Cochrane - Image-Guided Versus Blind Glucocorticoid Injection For Shoulder Pain (Review) PDF

Image-guided versus blind glucocorticoid injection for shoulder pain (Review)
Bloom JE, Rischin A, Johnston RV, Buchbinder R
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2012, Issue 8 http://www.thecochranelibrary.com
Image-guided versus blind glucocorticoid injection for shoulder pain (Review) Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . . BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.1. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 1 Overall pain (or daytime, activity-related or unspecied). . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.2. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 2 Function. Analysis 1.3. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 3 Proportion of patients showing 50% improvement at 6 weeks. . . . . . . . . . . . . . . . . . . . . . . Analysis 1.4. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 4 Range of abduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.5. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 5 Range of exion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.6. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 6 Number of adverse events. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 2.1. Comparison 2 Sensitivity analysis (adequate treatment allocation concealment, and blinding), Outcome 1 Overall Pain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 2.2. Comparison 2 Sensitivity analysis (adequate treatment allocation concealment, and blinding), Outcome 2 Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . . INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 2 3 7 8 8 10 11 14 17 18 19 19 21 37 38 39 40 41 42 43 44 44 44 46 49 49 49 50 50
[Intervention Review]
Image-guided versus blind glucocorticoid injection for shoulder pain

Jason E Bloom1 a , Adam Rischin2 b , Renea V Johnston3 , Rachelle Buchbinder3 University, Parkville, Australia. 2 Monash University, Clayton, Australia. 3 Monash Department of Clinical Epidemiology at Cabrini Hospital, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Malvern, Australia
a Joint 1 Melbourne
rst author. b Joint rst author
Contact address: Rachelle Buchbinder, Monash Department of Clinical Epidemiology at Cabrini Hospital, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Suite 41, Cabrini Medical Centre, 183 Wattletree Road, Malvern, Victoria, 3144, Australia. rachelle.buchbinder@monash.edu. Editorial group: Cochrane Musculoskeletal Group. Publication status and date: New, published in Issue 8, 2012. Review content assessed as up-to-date: 14 December 2011. Citation: Bloom JE, Rischin A, Johnston RV, Buchbinder R. Image-guided versus blind glucocorticoid injection for shoulder pain. Cochrane Database of Systematic Reviews 2012, Issue 8. Art. No.: CD009147. DOI: 10.1002/14651858.CD009147.pub2. Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT Background Traditionally, glucocorticoid injection for the treatment of shoulder pain has been performed guided by anatomical landmarks alone. With the advent of readily available imaging tools such as ultrasound, image-guided injections have increasingly become accepted into routine care. While there is some evidence that the use of imaging improves accuracy, it is unclear from current evidence whether or not it improves patient-relevant outcomes. Objectives The aim of this review was to assess whether image-guided glucocorticoid injections improve patient-relevant outcomes compared to landmark-guided or systemic intramuscular injections in patients with shoulder pain. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL, via The Cochrane Library), MEDLINE (Ovid), and EMBASE (Ovid) to June 2011. We also searched the World Health Organisation International Clinical Trials Registry Platform (http:/ /www.who.int/trialsearch/Default.aspx) to identify ongoing trials and screened reference lists of retrieved review articles and trials to identify potentially relevant studies. Selection criteria We included randomised controlled trials (RCTs) and quasi-randomised controlled clinical trials that compared image-guided glucocorticoid injection to landmark-guided or systemic intramuscular injection. Outcomes of interest included pain, function, range of motion, proportion of participants with overall improvement and adverse events. There were no restrictions on language or date of publication.
Image-guided versus blind glucocorticoid injection for shoulder pain (Review) Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1
Data collection and analysis Two review authors independently selected the studies for inclusion, extracted the data and performed a risk of bias assessment. Disagreement about inclusion or exclusion of individual studies and risk of bias was resolved by a third review author. Main results Five studies (290 participants) were included in the review. The image-guided groups in all trials used ultrasound to guide injection. Four studies included participants with rotator cuff disease; in three the comparator was local landmarks to direct injection into the subacromial bursa and in the fourth the comparator was systemic intramuscular injection into the upper gluteal muscles in the buttock region. One study included participants with adhesive capsulitis and injection was directed into the glenohumeral joint by either ultrasound or anatomical landmark guidance. No signicant differences between groups were observed with respect to reduction in pain at one to two weeks (two trials, 146 participants, standardized mean difference (SMD) -1.44, 95% CI -4.14 to 1.26), or function at one to two weeks (two trials, 146 participants, SMD 0.95, 95% condence interval (CI) -1.29 to 3.20; back-translated to mean difference (MD) 4 points, 95% CI -5 to 13, on a 0 to 100 point scale, higher score means better function) or six weeks (three trials, 207 participants, SMD 0.63, 95% CI 0.06 to 1.33; back-translated to MD -3 points, 95% CI -11 to 5, on a 0 to 100 point scale) and the sensitivity analyses did not alter these results. While there was a signicant difference between groups with respect to reduction in pain at six weeks favouring image guidance (three trials, 207 participants, SMD -0.80, 95% CI -1.46 to -0.14), there was considerable statistical heterogeneity and after removing trials with inadequate allocation concealment and inadequate blinding in a sensitivity analysis, the difference was no longer signicant (one trial, 106 participants, MD -0.60 points, 95% CI -1.44 to 0.24 points on a 9-point scale). No statistical difference in adverse events between groups was identied (10/104 image-guided group versus 16/103 comparator; risk ratio (RR) 0.55, 95% CI 0.17 to 1.85). Minor adverse events reported included transient post-injection pain, facial redness and warmth. Authors conclusions Based upon moderate evidence from ve trials, our review was unable to establish any advantage in terms of pain, function, shoulder range of motion or safety, of ultrasound-guided glucocorticoid injection for shoulder disorders over either landmark-guided or intramuscular injection. The lack of any added benet of ultrasound guided subacromial bursal injection over glucocorticoid injection administered into the upper gluteal muscles of the buttock suggests that the benets of glucocorticoid may arise through systemic rather than local effects. Therefore, although ultrasound guidance may improve the accuracy of injection to the putative site of pathology in the shoulder, it is not clear that this improves its efcacy to justify the signicant added cost.
PLAIN LANGUAGE SUMMARY Image-guided versus blind glucocorticoid injection for shoulder pain This summary of a Cochrane review presents what we know from research on whether using images (e.g. ultrasound) to guide injections into specic sites in the shoulder improves outcomes (e.g., pain, function) compared to no images in patients with shoulder pain. This review shows that in people with shoulder pain who are treated with a glucocorticoid injection: - Placing an injection into the shoulder guided by ultrasound imaging may not improve pain or function any more than placing the injection into the shoulder without ultrasound (blind injection) or placing the injection into the buttock muscles. - Success, as assessed by the participant was not reported. - Ultrasound-guided injection into the sore shoulder may not result in any more adverse events (such as facial redness, warmth, postinjection pain) compared with blind injection into the sore shoulder or injection into the buttocks. What are the common causes of shoulder pain and what are glucocorticoid injections? Shoulder pain is most commonly caused by rotator cuff disease. The rotator cuff is a group of tendons that contribute to hold the shoulder joint in place. The rotator cuff helps people lift their arm and reach overhead. In a lot of people, wear and tear of the rotator cuff tendons is a normal part of ageing and they may not have symptoms. However many people will develop pain in their shoulder at some time as the tendons degenerate further and tears in the rotator cuff tendons develop. There may also be inammation of the shoulder tendons or bursa (another part of the shoulder that helps it move). Often the pain is made worse by sleeping on the affected
shoulder and moving the shoulder in certain directions. Often there will be pressure on the tendons by the overlying bone when lifting the arm up. This is called impingement. It may become difcult to use the shoulder in every day activities, sports or work. Adhesive capsulitis (also called frozen shoulder, stiff painful shoulder or periarthritis) is also a common cause of shoulder pain and stiffness. It is believed to be due to inammation in the lining of the joint of unknown cause. As well as being painful, adhesive capsulitis also tends to cause stiffness in the shoulder resulting in pain and difculties moving the arm in all directions. The pain and stiffness in the shoulder can last up to 2 to 3 years before going away but in the early stages it can be very painful. Glucocorticoids injections are known to relieve shoulder pain but their effect usually wears off after six to eight weeks. Traditionally, a doctor uses anatomic landmarks around the shoulder to guide the injection into the desired location around the shoulder depending upon the cause. The injection can be placed in the shoulder joint or in locations around the shoulder such as the space under the acromion above the top of the humerus and the doctor can approach the patient from the front, side or back. Sometimes imaging techniques, such as ultrasound are used to more accurately guide the injections into the specic sore part of the shoulder, but it is not known if image-guided injection relieves the symptoms of shoulder pain more effectively than if the injection was delivered blind, i.e., without imaging, either into the same location in the shoulder, or even injected into muscle away from the shoulder (e.g., into the buttocks muscle). Best estimate of what happens to people who have image-guided injection compared with those who have an injection without imaging: Pain (higher scores mean worse pain): People who had image-guided injection rated their pain 0.2 points better on a 1 to 9 point scale (ranging from 0.1 points better to 0.07 points worse) 2 weeks after treatment (2% absolute improvement, ranging from 11% improvement to 7% worsening); and 0.6 points better (ranging from 1 point better to 0.24 points worse) 6 weeks after treatment (7% improvement (ranging from 16% improvement to 3% worsening). Function (lower scores mean better function or less disability): People who had image-guided injection rated their function 4 points worse on a 0 to 100 point scale (ranging from 13 points worse to 5 points better) at 2 weeks after treatment (4% worsening, ranging from 13% worsening to 5% improvement); and 3 points better (ranging from 11 points better to 5 points worse) 6 weeks after treatment (3% improvement, ranging from 11% improvement to 5% worsening). Side effects: - 6 fewer people out of 100 had minor side effects such as transient pain at the site of the injection or facial ushing with image-guided injection (6% absolute improvement, ranging from 16% improvement to 2% worsening). - 9 people out of 100 had minor side effects with image-guided injection. - 15 people out of 100 had minor side effects with injection without imaging.
S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation]
Ultrasound-guided injection compared to landmark or intramuscular injection for shoulder pain
Patient or population: Patients with shoulder pain Settings: International; clinic/hospital Intervention: Ultrasound-guided injection Comparison: Landmark or intramuscular injection Illustrative comparative risks* (95% CI) Relative effect (95% CI) No of Participants (studies) Quality of the evidence (GRADE) Comments
Outcomes
Assumed risk Landmark or intramus- Ultrasound-guided cular injection jection Mean pain 0.20 points lower (1.04 points lower to 0. 64 points higher) 106 (1 study) in-
Corresponding risk
Overall Pain - 1 to 2 4.5 points weeks (adequate allocation concealment, and blinding) visual analogue scale; 1 to 9 points (higher indicates worse pain) Mean pain 0.60 points lower (1.44 lower to 0.24 higher)
moderate2
Absolute risk difference 2% (-12 to 7%); relative percent change -3% (-16 to 10%); NNT n/a1
Overall Pain - 6 4.6 points weeks (adequate allocation concealment, and blinding) visual analogue scale; 1 to 9 points (higher indicates worse pain) Mean function 4 points higher (5.15 lower to 13.15 higher)
106 (1 study)
moderate2
Absolute risk difference 7% (-16 to 3%); relative percent change -10% (23 to 4%); NNT n/a1
Function - 1 to 2 28 points weeks (adequate allocation concealment, and blinding) Disability of Arm, Shoul-
106 (1 study)
moderate2
Absolute risk difference 4% (-13 to 5%); relative percent change 8% (-27 to 11%); NNT n/a1
der, Hand (DASH) scale; 0 to 100 points (lower score indicates better function) Mean function 3 points lower (11.38 lower to 5.38 higher) moderate3 147 (2 studies) Absolute risk difference 3% (-11 to 5%); relative percent change -6% (-22 to 11%), NNT n/a1
Function - 6 weeks (ad- 32 points equate allocation concealment, and blinding) DASH scale; 0 to 100 points (lower score indicates better function) See comment See comment Not estimable See comment
Participant-assessed success - not measured RR 0.55 (0.17 to 1.85) 85 per 1000 (26 to 287) 207 (3 studies)
This outcome was not measured in the trials moderate4 Absolute risk difference 7% fewer events in the image-guided group (16% fewer to 2% more); relative percent change -45% (-83 to 85%); NNT n/a1,3
Number of adverse Study population events - 6 weeks 155 per 1000 Follow-up: 6 weeks
Medium risk population 170 per 1000 94 per 1000 (29 to 315) See comment Not estimable See comment
Serious adverse events See comment - not reported
One trial (Ekeberg) reported that there were no serious side effects. The remaining trials did not report the incidence of serious adverse events
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
Number needed to treat (NNT)=not applicable (n/a) when result is not statistically significant. NNT for dichotomous outcomes calculated using Cates NNT calculator (http://www.nntonline.net/visualrx/). NNT for continuous outcomes calculated using Wells Calculator (CMSG editorial office) Potential imprecision due to availability of only 1 trial of 106 participants, and possibility of publication bias Two trials did not adequately conceal treatment allocation, and two did not blind participants Three trials reported adverse events; one trial (Chen 2006) did not report this outcome
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BACKGROUND
systemic effect and does not rely on the accuracy of the needle placement. Overall these conicting trials do not provide denitive proof one way or another, of the association between accuracy and outcome.
Description of the intervention

Glucocorticoid injections, which act to reduce inammation, are commonly used in routine care to treat shoulder pain due to various conditions including rotator cuff disease (degeneration and tears of the rotator cuff tendons that help to stabilise and move the shoulder) and adhesive capsulitis (also termed frozen shoulder or painful stiff shoulder). They are recommended as standard treatment in the clinical guideline for shoulder pain developed by the American Academy of Orthopaedic Surgeons (American Academy of Orthopedic Surgeons 2001). Traditionally, injection has been performed in the doctors ofce at the time of the consultation, using anatomical landmarks to guide needle placement into the subacromial space and/or glenohumeral joint (shoulder joint). However, with the advent of new imaging modalities such as ultrasound, more people are referred for injections using image guidance. While results of placebo-controlled trials of glucocorticoid injection have been mixed, systematic reviews that have synthesised the evidence from these trials have reported that these injections provide signicant short-term benet (Buchbinder 2003). A more recent review reported a relative risk for improvement for subacromial corticosteroid injection for rotator cuff tendonitis to be 3.08 (95% CI 1.94 to 4.87) and the number needed to treat based on the pooled relative risk to be 3.3 (95% CI 1.8 to 7.7) patients to obtain one improvement with benets maintained for up to 9months (Arroll 2005). They also found that subacromial steroid injections are probably more effective than NSAID medication. Only 30 to 80% of subacromial injections given as a blind injection are reported to reach the subacromial bursa or space (Eustace 1997; Partington 1998; Henkus 2006), although in expert hands, blinded injection may not differ in accuracy to ultrasound-guided injection (Rutten 2007). For glenohumeral injections, the reported accuracy of blinded injections has varied from 27% (Porat 2008); to 99% (Sethi 2005) with one study reporting that accuracy was greater with an anterior approach (Intra-articular in 95% given by anterior approach versus 50% given by a posterior approach) (White 1996). However, the importance of the accuracy of needle placement with respect to outcome has only recently been studied and ndings are inconsistent (Hall 2004). While some studies report a greater degree of improvement with accurate needle placement (Eustace 1997; Henkus 2006), others have not (Yamakado 2002; Esenyel 2003; White 1996). Several randomised controlled trials that have examined the importance of accurate needle placement in other regions have been unable to demonstrate an advantage over blind injections (Taras 1998; Kane 2001; Shanahan 2004). As well, two trials have reported similar outcomes from subacromial corticosteroid injections and similar injections placed in the gluteal region (buttock) (Valtonen 1978; Ekeberg 2009). This suggests that any therapeutic benet of the injection may be derived from its
How the intervention might work

Glucocorticoid injections are potent anti-inammatories and have both systemic and local effects (Ekeberg 2009; Pekarek 2011). The onset, duration, and local effect depends upon the anti-inammatory potency of the glucocorticoid, its solubility (depot effect), and the dose given; and may be short, intermediate or long acting corresponding to their anti-inammatory potency (Pekarek 2011). A variety of imaging methods have been used to better localise needle placement for glucocorticoid injection into the subacromial bursa or space (the bursa or space under the acromion) or the glenohumeral joint (shoulder joint). Potential advantages of image guidance might be increased safety (avoidance of important neurovascular structures), decreased discomfort, and diagnostic value in terms of response to accurate anatomic administration. Ultrasound imaging uses no radiation and can be used to visualize subcutaneous body structures including tendons, muscles and joints. Computerized tomography (CT) scans or magnetic resonance imaging (MRI) scans may also be used to visualise the structures around the shoulder. A series of images, usually X-rays, can be taken after injection of a small amount of contrast (an arthrogram) to ensure that a needle is placed in the correct position in the joint. In contrast to anatomical landmark-guided injection which in many instances can be performed by trained general practitioners or specialists such as rheumatologists and orthopaedic surgeons, most image-guided procedures are performed by radiologists in a radiology service. While still in the minority, some clinical specialists are now learning these techniques and may have the necessary equipment to perform image-guided injections in their ofce.
Why it is important to do this review

It is important to know whether image-guided injection improves outcomes for people with shoulder disorders. Any added benet in patient outcome achieved by the image-guided approach will also need to be considered in light of any delay in receiving imageguided treatment and the added expense of the imaging modality used. In Australia, there has been more than a 28-fold increase in the number of image-guided injections since 2000 from 3,504 services in 2000-01 (18 per 100,000 population) to 99,208 services in 2008-9 (2036 per 100,00 population) (Medicare Australia 2010). This has been accompanied by a substantial increase in health care costs. Whether image-guided corticosteroid injection is a cost-effective therapeutic tool for improving the care and outcomes of people
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with shoulder disorders is not yet established.
Overall pain measured by visual analogue scales, numerical or categorical rating scales; Function as measured in the trials (e.g., Shoulder Pain and Disability Index (SPADI), Constant score). The primary safety outcome was the number of participants experiencing any adverse event.
Secondary outcomes
OBJECTIVES
To assess the benet, in terms of pain and function, and harms of image-guided glucocorticoid injections (e.g., injection guided by ultrasound or other imaging modality) into the subacromial bursa or space or glenohumeral joint compared with blind injection (that relies on anatomical landmarks) or systemic intramuscular injection for people with shoulder pain.
METHODS
Criteria for considering studies for this review

Types of studies We included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) that use quasi-randomised methods to allocate participants, for example by date of birth, hospital record number, or alternation. There were no restrictions on language or date of publication. Types of participants Trials that included participants with rotator cuff disease or adhesive capsulitis (as dened by the authors) of any age were included. We also included trials with participants of unspecied shoulder pain provided that the inclusion/exclusion criteria were compatible with a diagnosis of either rotator cuff disease or adhesive capsulitis. We excluded trials that included participants with osteoarthritis where this was the primary diagnosis, a history of signicant injury or fracture, and systemic inammatory conditions such as rheumatoid arthritis or polymyalgia rheumatica. Types of interventions Trials comparing image-guided (ultrasound, arthrogram or MRI) subacromial and/or glenohumeral injection to blind injection (i.e., injection relying on anatomical landmarks) or systemic intramuscular injection of corticosteroid were included. Trials that only considered accuracy of needle placement were excluded. Types of outcome measures
Measures of treatment success as dened in the trials (e.g., Proportion of participants with a signicant overall improvement) Other pain outcomes (e.g., night pain, pain at rest or with activities and pain with resisted movements) Range of motion Strength Quality of life The number of participants experiencing any serious adverse event Work disability We planned to extract outcome measures assessing the benet of treatment (e.g., pain and function) at the following time points: short term follow-up (up to 6 weeks following treatment); intermediate follow-up (> 6 weeks up to 6 months after the end of treatment; and longer term follow-up (> 6 months after the end of treatment). However, no trials were longer than 6 weeks and we therefore extracted outcome data at the following time points: up to 2 weeks following treatment and 6 weeks following treatment. We extracted all adverse events. The main results of the review are presented in summary of ndings (SoF) tables which provides key information concerning the quality of evidence, the magnitude of effect of the interventions examined, and the sum of available data on the outcomes. We included the following outcomes in the summary of ndings tables: pain; function; number of participants experiencing any serious adverse events; patient global assessment of success; and number of participants experiencing any adverse events. We included only trials with adequate allocation concealment and blinding of participants in the summary of ndings table for pain and function.
Search methods for identication of studies
Electronic searches We searched the following electronic databases, unrestricted by date or language up to June 2011: Cochrane Central Register of Controlled Trials (CENTRAL, via The Cochrane Library); MEDLINE (Ovid); EMBASE (Ovid);
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Primary outcomes
The primary efcacy outcomes were:
CINAHL (Ovid up to 2008; EBSCOHost 2008 to 2011); and ISI Web of Knowledge Specic subject headings and additional text words describing the intervention and participants were used to identify relevant trials. The complete search strategies for the MEDLINE database search is provided in Appendix 1. This strategy was adapted to the other electronic databases as appropriate (Appendix 2; Appendix 3; Appendix 4; Appendix 5). Searching other resources We searched the World Health Organisation International Clinical Trials Registry Platform (http://www.who.int/trialsearch/ Default.aspx) to identify ongoing trials. We also screened reference lists of retrieved review articles and trials to identify potentially relevant studies.
with other types of pain in the following hierarchy: unspecied pain or pain with activity or daytime pain. Where trials included more than one measure of function, for the purpose of pooling of data, we preferentially included the one according to the following hierarchy: primary outcome, outcome with the better delineated measurement properties. Where trials included both active and passive ROM we preferentially included active ROM for the purposes of data pooling. If additional data were required, we contacted the trial authors to obtain this. Where data were imputed or calculated (e.g., standard deviations calculated from standard errors, P values, or condence intervals, or imputed from from graphs, or from standard deviations in other trials) we reported this in the Characteristics of included studies table. Any disagreements were resolved by consensus and/or arbitration by a third review author (RB).
Assessment of risk of bias in included studies Two review authors (JB, AR) independently assessed the risk of bias of each included trial and resolved any disagreements by consensus, or consultation with a third review author (RB) where necessary. We assessed the following methodological domains, as recommended by The Cochrane Collaboration (Higgins 2008): sequence generation allocation sequence concealment blinding of participants, personnel and outcome assessors incomplete outcome data; selective outcome reporting; and other potential threats to validity. Each of these criteria were explicitly judged as: low risk of bias; high risk of bias; or unclear risk of bias (either lack of information or uncertainty over the potential for bias).
Data collection and analysis
Selection of studies Two review authors (JB, AR,) independently selected the trials to be included in the review and all articles selected by at least one of the review authors were retrieved for closer examination. The review authors were not blinded to the journal or authors. Disagreement about inclusion or exclusion of individual studies was resolved by a third review author (RB). Data extraction and management The same two review authors (JB, AR) independently extracted the following data from the included trials and entered the data in RevMan 5: 1) trial characteristics including size and location of the trial, and source of funding; 2) characteristics of the study population including age, and characteristics of shoulder pain including diagnosis criteria, and disease duration; 3) characteristics of the therapy in all trial arms including type and dose of corticosteroid therapy, site of injection and the method of anatomic or image-guided location of the needle; 4) methodologic domains as outlined in Assessment of risk of bias in included studies, below; 5) outcome measures - mean and standard deviation for continuous outcomes, and number of events for dichotomous outcomes (as outlined in Types of outcome measures). Where trials did not include a measure of overall pain but included one or more other measures of pain, for the purpose of pooling data for the primary analysis of pain, we combined overall pain
Measures of treatment effect When possible, the analyses were based on intention-to-treat data (outcomes provided for every randomised participant) from the individual trials. For each trial, we present outcome data as point estimates with mean and standard deviation for continuous outcomes and risk ratios (RRs) with corresponding 95% condence interval for dichotomous outcomes. Where possible, for continuous outcomes, we extracted end of treatment scores, rather than change from baseline scores. For continuous data, results were presented as mean differences (MD), if possible. However, where different scales were used to measure the same outcome or concept, standardized mean differences (SMD) was used.
Unit of analysis issues The unit of analysis was the participant. We did not identify any trials that injected both shoulders.
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Dealing with missing data We contacted trial authors to obtain data that was missing from the trial reports. For dichotomous outcomes, we used number randomised as the denominator, making the assumption that any participants missing at the end of treatment did not have a positive outcome. For continuous outcomes with no standard deviation reported, we calculated standard deviations if possible from standard errors, P values, or condence intervals. If no measures of variance were reported and standard deviation could not be calculated, we planned to impute standard deviations from other studies in the same meta-analysis, using the average of the other standard deviations available provided only a small proportion of studies comprising the meta-analysis had missing data. Assessment of heterogeneity We assessed included trials for clinical homogeneity in terms of participants and interventions and comparators. For studies judged as clinically homogeneous, we quantied the possible magnitude of inconsistency (i.e. heterogeneity) across studies, using the I2 statistic with a rough guide for interpretation as follows: 0% to 40% might not be important; 30% to 60% may represent moderate heterogeneity; 50% to 90% may represent substantial heterogeneity; 75% to 100% considerable heterogeneity (Deeks 2008). Assessment of reporting biases To examine the possibility of publication bias, we planned to construct funnel plots if at least 10 studies were available for the meta analysis of a primary outcome. However, we identied too few trials for this analysis. We planned to assess the presence of small study bias in the overall meta-analysis by checking if the random-effects estimate of the intervention effect was more benecial than the xed-effect estimate but again there were too few trials for this analysis. Data synthesis For clinically homogeneous studies, we pooled outcomes in a meta analysis using the random-effects model as a default. Subgroup analysis and investigation of heterogeneity In order to explain the heterogeneity between the results of the included studies, the following subgroup analyses were planned. 1. To assess if different diagnoses affect outcomes, we planned to present outcomes separately by diagnosis (rotator cuff disease, versus adhesive capsulitis, versus mixed or undened shoulder pain) 2. To assess if site of injection affects outcome (injection into the glenohumeral space versus subacromial space).
Too few trials were available to perform subgroup analyses. Sensitivity analysis We performed a sensitivity analysis to investigate the robustness of the treatment effect (of pain and function) to allocation concealment and participant blinding, by removing the trials that reported inadequate or unclear allocation concealment and lack of participant blinding from meta-analysis to see if this changed the overall treatment effect.
Presentation of key results
We presented the main results of the review in summary of ndings (SoF) tables which summarise the quality of evidence, the magnitude of effect of the interventions examined, and the sum of available data on the outcomes as recommended by the Cochrane Collaboration (Schnemann 2008a). The summary of ndings table includes an overall grading of the evidence related to each of the main outcomes, using the GRADE approach (Schnemann 2008b). In addition to the absolute and relative magnitude of effect provided in the summary of ndings table, for dichotomous outcomes (adverse events), the number needed to treat to benet (NNTB) or the number needed to treat to harm (NNTH) was calculated from the control group event rate and the risk ratio using the Visual Rx NNT calculator (Cates 2004). For continuous outcomes, pain and function, the NNT was calculated using the Wells calculator software available at the CMSG editorial ofce (www.cochranemsk.org). We assumed a minimal clinically important difference (MCID) of 1.5 points on a 10-point scale for pain, and 10 points on a 100 point scale for function or disability for input into the calculator.
RESULTS
Description of studies
See: Characteristics of included studies; Characteristics of excluded studies; Characteristics of studies awaiting classication. Results of the search The initial database search identied 1664 records and one additional record was identied from a recently published systematic review (Soh 2011)(see ow chart in Figure 1). There were 574 records after removal of duplicates of which 22 possibly eligible studies were assessed in full text. Of these, ve studies published between 2004 and 2009 and involving 290 participants (range 40 to 106), were included in the review.
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Figure 1. Study ow diagram.
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Included studies See Characteristics of included studies and Additional Table 1. Design Three of the included studies were randomised controlled trials (Ekeberg 2009; Naredo 2004; Ucuncu 2009); one trial was categorised as a controlled clinical trial as participants were alternately assigned to treatment (Lee 2009); while the fth trial, also categorised as a controlled clinical trial, did not specify how participants were allocated to treatment group (Chen 2006). Participants Four trials included participants that could be categorised as having rotator cuff disease (Chen 2006; Ekeberg 2009; Naredo 2004; Ucuncu 2009). Chen 2006 included 40 participants with sonographic conrmation of subacromial bursitis (mean age: 53 years, ratio males to females: 2:1; duration of symptoms ranged between 2 and 10 months). Ekeberg 2009 included 106 participants with rotator cuff disease (mean age: 51 and 50 years in the ultrasound-guided and intramuscular gluteal injection groups respectively; 41 males and 65 females, duration of symptoms: <6 months: N=30 (28%), 6-12 months: N=32 (30%), >1 year to 2 years: N=18 (17%) and >2 years N=26 (25%)). Naredo 2004 included 41 participants with periarticular disorders (mean age: 52.9 and 51.9 years and mean duration of symptoms: 11.9 and 10.2 months in the ultrasound- and landmarkguided injection groups respectively). Ucuncu 2009 included 60 participants with soft-tissue lesions of the shoulder (mean age: 52.1 and 52.9 years in the ultrasound and landmark-guided injection respectively, 16 males and 44 females, mean duration of symptoms: 10.7 and 9.6 months in the ultrasound- and landmark-guided groups respectively). One trial included 43 participants with adhesive capsulitis (Lee 2009) (baseline data only recorded for the 40 participants (20/22 in landmark-guided group and 20/21 in the ultrasound-guided group) who completed the 6-week study: mean age: 53.1 and 54.1 years in the ultrasound- and landmark-guided groups respectively; 19 males, 21 females; mean duration of symptoms: 8.5 and 10.6 months in the ultrasound- and landmark-guided groups respectively). Interventions The landmark-guided glucocorticoid injections of three studies ( Chen 2006; Naredo 2004; Ucuncu 2009) targeted the subacromial bursa, while Lee 2009 targeted the glenohumeral joint, and Ekeberg 2009 targeted the upper gluteal buttock region (intramuscular injection). Image guidance in all trials utilised ultrasound. In two studies, ultrasound was used to direct the injection to the site of observed
pathology (Naredo 2004; Ucuncu 2009), while in the other three studies the ultrasound image targeted either the subacromial bursa (Chen 2006; Ekeberg 2009) or glenohumeral joint (Lee 2009). The dose and type of glucocorticoid and local anaesthetic used varied between studies. Three studies used 20mg triamcinolone (Ekeberg 2009; Lee 2009; Naredo 2004); one trial used 40mg triamcinolone (Ucuncu 2009), and one used 1ml betamethasone (dosage not specied) (Chen 2006). One week after glucocorticoid injection, all participants in Lee 2009 received 5 x weekly injections of low-molecular-weight sodium hyaluronate (25mg) and we therefore only considered their one-week data for the purpose of this review. Outcomes Four of the ve trials included at least one pain measure (Ekeberg 2009; Lee 2009; Naredo 2004; Ucuncu 2009)(see Additional Table 1) but the type of pain varied and no trial measured pain in exactly the same way. Ekeberg 2009 measured pain at rest and with activity; Lee 2009 measured pain in the daytime and just before sleep; Naredo 2004 measured pain in the previous week; and Ucuncu 2009 did not specify type of pain. Both Naredo 2004 and Ucuncu 2009 were considered to have measured our primary outcome of overall pain but for the purpose of pooling we also included pain with activity measured in Ekeberg 2009 and pain in the daytime measured in Lee 2009. Four of the ve trials included at least one measure of function (Ekeberg 2009; Lee 2009; Naredo 2004; Ucuncu 2009)(see Additional Table 1) but no trials used the same tool. Ekeberg 2009 included the SPADI (primary outcome), Western Ontario Rotator Cuff Index and a self-assessment of change in main complaint; Lee 2009 included the Functional Activities of the Shoulder scale which was developed for the study; Naredo 2004 include the Shoulder Function Assessment (SFA) scale; and Ucuncu 2009 included the Constant score. Three trials reported on adverse events (Ekeberg 2009; Naredo 2004; Ucuncu 2009). Only one trial included any dichotomous measures of treatment success. Naredo 2004 measured the number of participants with 50% improvement in pain and SFA score. All ve trials included a measure of range of motion including abduction, but measurements varied between trials. Chen 2006 only measured range of abduction (active or passive not specied); Ekeberg 2009 measured active abduction and exion; Lee 2009 measured passive abduction, exion, extension, internal and external rotation; Naredo 2004 measured active and passive abduction, exion, internal and external rotation; while Ucuncu 2009 measured active and passive abduction and exion. No trials measured health-related quality of life or work disability.
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Excluded studies See Characteristics of excluded studies. Seventeen studies assessed in full text were excluded. Seven studies were not randomised or quasi-randomised controlled trials (Alfredson 2006; Bamji 2004; Esenyel 2003; Gutierrez 2004; Koes 2009; McCormack 2009; Yi 2006) ; two studies did not include the participants of interest (Cohen 2009; Sibbitt 2009); four studies did not include the interventions of interest (Buchbinder 2004; Henkus 2006; Kang 2008; Widiastuti-Samekto 2004); two studies did not include the comparator of interest (Chavez-Lopez 2009; Tveita 2008); and one study did not measure the correct outcomes (Rutten 2007). One
study was excluded because data were not presented separately for participants who were randomly allocated to either subacromial steroid injection, intramuscular gluteal steroid injection or intramuscular gluteal placebo injection by birth date from 60 consecutive patients who had been given subacromial steroid injection and 30 consecutive patients who had been given intramuscular gluteal steroid injection (Valtonen 1978).
Risk of bias in included studies

See Characteristics of included studies. The results of the risk of bias assessment are also presented graphically in Figure 2.
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Figure 2. Risk of bias summary: review authors judgements about each risk of bias item for each included study.
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Summary of risk of bias by trial Only one study was assessed as low risk of bias in all categories (Ekeberg 2009). This double-blind randomised trial compared ultrasound-guided injection of glucocorticoid with intramuscular injection into the gluteal muscles in the buttock. Both groups received local anaesthetic into the shoulder and gluteal region to ensure participants were blinded and injections for both groups were performed by the same physician. This was the only trial that provided a sample size calculation. Only one other study was assessed as low risk for random sequence generation and allocation concealment (Naredo 2004). This trial blinded a single outcome assessor but did not blind participants to treatment allocation and results for range of movement were incompletely reported. Three of the other trials had signicant methodological aws that rendered them at high risk of bias. It was unclear whether or not the trial by Chen 2006 was randomised and/or concealed treatment allocation, blinded participants, study personnel and/or outcome assessment. Different physicians performed injections for both groups, only one outcome was reported to have been measured and the number of participants assessed at one week was not reported. In addition, no between group analysis was performed. The trial by Lee 2009 did not adequately randomise participants and treatment allocation was not concealed although participants and the single outcome assessor were blinded to treatment allocation. Like Chen 2006, different physicians performed the injections for each group. The trial by Ucuncu 2009 did not describe their method of randomisation and did not specify whether treatment allocation was concealed, did not blind participants and did not state whether or not outcome assessment was blinded. In addition it did not report whether or not all participants were included in the analysis and provided no details about who performed the injections. As well, baseline function was imbalanced between groups and could have favoured the ultrasound-guided group. Allocation Two studies were assessed as low risk of selection bias (Ekeberg 2009; Naredo 2004); both were assessed as having adequate random sequence generation and allocation concealment. One trial was assessed as high risk of selection bias as participants were allocated to treatment group on an alternate basis and treatment allocation was not blinded (Lee 2009). Two trials were assessed as unclear risk of selection bias (Chen 2006; Ucuncu 2009): one trial, reported to be a randomised, did not specify the method of random sequence generation and it was not clear whether or not treatment allocation was concealed (Ucuncu 2009), and the other trial did not specify how participants were allocated to treatment groups or whether or not treatment allocation was concealed (Chen 2006).
Blinding None of the trials blinded the study personnel who administered the interventions. Two trials adequately blinded both participants and outcome assessors (Ekeberg 2009; Lee 2009). Naredo 2004 adequately blinded a single outcome assessor, but did not blind participants to treatment allocation. Chen 2006 did not report whether or not participants or study personnel were blinded and did not provide any details about outcome assessment. Ucuncu 2009 did not blind participants and did not specify whether or not outcome assessment was blinded.
Incomplete outcome data Only two trials were assessed as low risk for attrition bias (Ekeberg 2009; Lee 2009). The remaining three trials inadequately described the number of participants completing the study, and were therefore classied as having an unclear risk of attrition bias (Chen 2006; Naredo 2004; Ucuncu 2009).
Selective reporting Four studies were assessed as being at low risk for reporting bias (Chen 2006; Ekeberg 2009; Lee 2009; Ucuncu 2009), while Naredo 2004 was assessed as being at unclear risk because for range of movement, only results for whether or not participants had active abduction impairment were reported; no goniometer measures were reported and no results for active exion and internal and external rotation were provided although these were all prespecied outcomes.
Other potential sources of bias For two trials, no other potential sources of bias were identied (Ekeberg 2009; Naredo 2004). In both Chen 2006 and Lee 2009 one physician performed all ultrasound-guided injections and a different physician performed all anatomic landmark-guided injections. If the expertise of these physicians differed then this could have biased the treatment effect estimates. Ucuncu 2009 did not specify who performed the injections and whether or not the same person performed injections for both groups. In two trials, there were baseline differences between groups that could have favoured the ultrasound-guided groups in both trials (Chen 2006; Ucuncu 2009). In Chen 2006 baseline shoulder abduction was slightly more restricted (worse) in the ultrasound-guided group, while in Ucuncu 2009 baseline function as measured by the Constant score was signicantly worse in the ultrasound-guided group.
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Effects of interventions
See: Summary of ndings for the main comparison Ultrasoundguided injection compared to landmark or systemic injection for shoulder pain Only one of the ve trials was considered sufciently free of bias (Ekeberg 2009). This trial did not observe any important differences in short term outcomes between ultrasound-guided injection into the subacromial bursa and intramuscular injection into the upper gluteal buttock region. While an argument could be made for dismissing the results of other trials, we elected to pool all the available data from all trials and performed a sensitivity analysis excluding trials with inadequate or unclear treatment allocation concealment. Although the trials differed somewhat in their study populations, each study addressed a similar question and measured outcomes in a similar way at similar time points so we considered there was sufcient clinical homogeneity to proceed.
landmark-guided/intramuscular injection in terms of improvement in function at six weeks (SMD 0.63 [-0.06, 1.33]). Again, there was considerable statistical heterogeneity (I2 =81%). See Analysis 1.3. Based upon one trial (Naredo 2004), signicantly more participants who received ultrasound-guided injection improved by at least 50% with respect to pain (RR 10.48 [1.49, 73.88]) although no difference between groups was observed for the proportion of participants who improved by at least 50% with respect to function (RR 2.38 [0.52, 10.90]).
Range of movement of the shoulder
Efcacy of ultrasound-guided injection versus landmark or intramuscular injection
Overall Pain (includes daytime, activity-related and unspecied pain)
See Analysis 1.4. Based upon three trials (Chen 2006; Ekeberg 2009; Lee 2009), range of abduction improved more with ultrasound-guided injection at two weeks (MD 19.77 [4.29, 35.26], however statistical heterogeneity was considerable (I2 =90%). The positive results of both Lee 2009 and Chen 2006 may be explained by lack of randomisation and blinded treatment allocation. Two trials contributed to the pooled analysis for range of abduction at 6 weeks (Ekeberg 2009; Ucuncu 2009) and no differences between groups were observed (MD 6.45 [-3.24, 16.15])(I2 =21%, interpreted as heterogeneity might not be important). No differences between treatment groups were observed for range of exion at either one to two or six weeks (see Analysis 1.5).
Safety of ultrasound-guided injection versus landmark or intramuscular injection
See Analysis 1.1. Based upon two trials (Ekeberg 2009; Lee 2009), there was no difference between ultrasound-guided and landmarkguided/intramuscular injection in terms of improvement in pain at one-two weeks (SMD -1.44 [-4.14, 1.26]), however there was considerable statistical heterogeneity (I2 =97%). The positive results favouring ultrasound-guided injection observed in Lee 2009 may be explained by lack of randomisation and blinded treatment allocation. Based upon three trials (Ekeberg 2009; Naredo 2004; Ucuncu 2009), ultrasound-guided injection was superior to landmarkguided/intramuscular injection in terms of improvement in pain at six weeks (SMD-0.80 [-1.46, -0.14]), however there was considerable statistical heterogeneity (I2 =79%). The benets of ultrasound-guided injection over landmark-guided injections observed in both Naredo 2004 and Ucuncu 2009 may be explained by lack of blinding of participants.
Function
See Analysis 1.2. Based upon two trials (Ekeberg 2009; Lee 2009), there was no difference between ultrasound-guided and landmarkguided/intramuscular injection in terms of improvement in function at one-two weeks (SMD 0.95 [-1.29, 3.20]). Similar to the results for overall pain, there was considerable statistical heterogeneity (I2 =96%). Based upon three trials (Ekeberg 2009; Naredo 2004; Ucuncu 2009), there was no difference between ultrasound-guided and
See Analysis 1.6. There were no important differences between groups with respect to reported adverse events in three trials (10/104 (9.6%) participants in the ultrasound-guided group and 16/103 (15.5%) participants in the landmark or intramuscular injection groups reported adverse events (RR 0.55 [0.17, 1.85])(Ekeberg 2009; Naredo 2004; Ucuncu 2009). Mild postinjection pain was observed in 6/50 (12%) participants in the landmark guided groups and 2/50 (4%) participants in the ultrasound-guided groups in two trials (Naredo 2004; Ucuncu 2009) while Ekeberg 2009 reported that one participant who received glucocorticoid injection in the shoulder and four participants who received glucocorticoid injection in the gluteal region had mild post-injection pain in the shoulder; and nine participants from both groups reported mild adverse effects such as facial redness, dizziness and a feeling of warmth. Ucuncu 2009 reported that one patient who received landmark injection developed skin peeling at the site. The other two trials did not report whether or not adverse events occurred and no serious adverse events were reported in any trials.
Sensitivity analyses
See Analysis 2.1; Analysis 2.2. After removing trials with inadequate or unclear allocation concealment or inadequate participant blinding, only one trial remained (Ekeberg 2009). There were no
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differences between groups with respect to improvement at pain one to two weeks (MD -0.20, 95% CI -1.04, 0.64 points, 9 point scale) or six weeks (MD -0.60, 95% CI-1.44 to 0.24 points on a 9-point scale), Similarly there were no differences between groups with respect to improvement in function (or reduction in disability), measured on the DASH scale at one to two weeks (MD 4.00, 95% CI -5.15 to 13.15 points, 100 point scale) or six weeks (MD -3.00, 95% CI -11.38 to 5.38 points, 100 point scale).
patients with either image- or landmark-guided or intramuscular injection.
Overall completeness and applicability of evidence

The ve trials included in this review all included participants with shoulder pain. Four of the trials included participants with rotator cuff disease Chen 2006; Ekeberg 2009; Naredo 2004; Ucuncu 2009) and one trial included participants with adhesive capsulitis (Lee 2009), and the site of injection varied across trials. However the study populations in all trials appeared to be representative of patients seen in routine care and the age, gender ratio and symptom duration was similar across studies. While no trial was longer than six weeks, the benets of glucocorticoid injection are immediate and generally only last for six to eight weeks (Buchbinder 2003), therefore longer trials are unnecessary to determine the comparative effectiveness of different forms of administration of glucocorticoid injection. Two of the trials excluded participants who had previously had glucocorticoid injected into the shoulder at any time (Naredo 2004; Ucuncu 2009) and one trial excluded participants who had had glucocorticoid into the shoulder within the preceding month, although about 40% of participants in both groups had previously received glucocorticoid injection into the shoulder (Ekeberg 2009). The other two trials did not specify whether or not participants had previously received glucocorticoid (Chen 2006; Lee 2009).
Summary of Findings
Moderate quality evidence from one trial indicates that there is no difference in pain or function with ultrasound-guided or systemic intramuscular injection of glucocorticoid, and moderate quality evidence from three trials suggests there is probably no difference in the incidence of adverse events between the two groups (Summary of ndings for the main comparison).
DISCUSSION
Summary of main results

Based upon the results of ve trials involving 290 participants, of which only one trial of 106 participants was deemed to be at low risk of bias, current evidence does not conrm an advantage of ultrasound-guided imaging for improving patient-relevant outcomes, such as pain and function, over landmark shoulder injection or systemic intramuscular injection for shoulder pain. While pooled data based upon three trials suggested a benet of ultrasound-guided injection over landmark-guided or intramuscular injection for pain at six weeks, there was considerable statistical heterogeneity and when the trials with inadequate allocation concealment and inadequate participant blinding were excluded in a sensitivity analysis, this benet was no longer apparent. This demonstrates that inadequately designed studies for conditions that are assessed by subjective outcomes are likely to overestimate treatment benets (Wood 2008). Based upon one trial that did not blind participants, signicantly more participants who received ultrasound-guided injection improved by at least 50% with respect to pain but not function at 6 weeks compared to landmark-guided injection. For range of motion only the pooled analysis for improvement in abduction at one to two weeks demonstrated a difference between groups, favouring the ultrasound-guided group. However this analysis also displayed considerable heterogeneity and was likely to be biased by the inclusion of two trials at high risk of bias. There was no demonstrable difference between groups with respect to safety. Mild post-injection pain and systemic effects of glucocorticoids (facial redness, warmth) may arise in a minority of
Quality of the evidence

The overall quality of the evidence was moderate applying the GRADE approach (Summary of ndings for the main comparison). We limited the presentation of pain and function to evidence from trials with adequate allocation concealment and adequate participant blinding. There was moderate quality evidence from one trial (106 participants) that there was no benet of ultrasound-guided injection over gluteal muscle injection in terms of pain or function at two or six weeks after treatment. The evidence was downgraded due to some imprecision around the effect size, and the potential for publication bias. Thus, although we can have some condence in the magnitude and direction of the effect, further trials may improve the precision. There was moderate quality evidence from three trials (207 participants) indicating no difference between groups in the number of adverse events and these were transient and mild. The evidence was downgraded because of lack of participant blinding in two of the three trials. There was no evidence available to assess participant assessment of success.
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Only one of the included trials was judged to be at low risk of bias across all risk of bias domains (Ekeberg 2009). Only one other trial adequately randomised participants and concealed treatment allocation although it did not blind participants (Naredo 2004) and only one other trial blinded participants (Lee 2009). Blinding participants is a necessary component of shoulder pain trials because the primary outcomes are predominantly self-reported (pain and function) and unblinded assessment of subjective outcomes are known to overestimate the treatment benet by about twenty ve percent (Wood 2008).
Potential biases in the review process

We believe that all relevant published studies were identied. One unpublished study (Saeed 2010) was identied and will be included in an update when it becomes available. A thorough search strategy was devised and all major databases were searched for relevant studies with no language restrictions applied. Two review authors assessed the trials for inclusion in the review and risk of bias, with a third reviewer adjudicating if there was any discrepancy. Apart from the risk of bias of the included trials, the biggest limitation of the review process was that the trials varied in their outcome measures. Measures of both pain and function varied across studies with no studies including the exact same measures. For overall pain, one of our pre-specied primary outcomes, we elected to pool results for pain with activity, daytime pain and unspecied type of pain, each measured on different scales. For function, we similarly pooled different measures that may not necessarily be measuring the exact same concept.
quality, adequately powered trial that fullled all criteria of low risk of bias in our assessment and failed to demonstrate a difference in efcacy between local ultrasound-guided injection and intramuscular injection in the upper gluteal buttock region. Furthermore, the pooled analysis of change in function at six weeks is likely to have overestimated the benet of ultrasound-guided injection as participants in one trial had signicantly worse functional scores at baseline (Ucuncu 2009) and the pooled analysis of change scores appeared to exaggerate this difference more than the nal score pooled analysis that we conducted. There continues to be debate in the literature regarding whether or not accuracy of glucocorticoid injections is a prerequisite for efcacy for the treatment of joint and soft tissue pathology (Hall 2004; Iagnocco 2010), with studies continuing to produce conicting results (Hartung 2010; Micu 2010; Sibbitt 2009). As outlined by Iagnocco 2010 and Naredo 2004 and Ekeberg 2009, the mechanism of local glucocorticoid action is not well understood. However the trial by Ekeberg et al provides evidence for a significant systemic effect as intramuscular injection of glucocorticoid into the upper gluteal region provided almost equivalent benet to glucocorticoid delivered locally (Ekeberg 2009). Use of ultrasound by clinicians as well as radiologists for both diagnostic and therapeutic purposes for a variety of musculoskeletal indications is expanding rapidly in many settings. There are distinct advantages of ultrasound guidance, for example, when diagnostic aspiration into joints that are deep and difcult to locate using landmark-guidance are necessary, or for injection of radioisotopes or visco supplementation where accuracy is paramount (Iagnocco 2010). However, the results of the one low risk of bias trial in our review, has questioned the need to accurately place the needle in the target area for the purpose of maximising efcacy when treating shoulder disorders. Further studies are justied to conrm this nding.
Agreements and disagreements with other studies or reviews

Another systematic review of image-guided injection versus landmark-guided injection for shoulder pain has been published since the publication of our review protocol (Soh 2011). They included only two of the ve trials included in our review (Naredo 2004; Ucuncu 2009). In contrast to our review, they concluded that patients who underwent image-guided (ultrasound) injections had statistically signicantly greater improvement in shoulder pain and function at six weeks compared with those who received blind (landmark-guided) injections although did note that the results should be interpreted cautiously in view of the limited number of studies and small sample sizes (Soh 2011). Their assessment of risk of bias for these trials differed from our own, and they pooled change scores while we pooled nal scores. Although no reasons were given for the exclusion of studies, the exclusion of both Chen 2006 and Lee 2009 from their review could have been justied on the basis that neither trial was clearly randomised. However, they also excluded Ekeberg 2009, a high
AUTHORS CONCLUSIONS Implications for practice

Based upon ve trials, our review was unable to establish any advantage in terms of pain, function, shoulder range of motion or safety, of ultrasound-guided glucocorticoid injection for shoulder disorders over either landmark-guided or intramuscular injection. The lack of any added benet of ultrasound guided injection into the subacromial bursa of the shoulder over intramuscular glucocorticoid injection administered into the upper gluteal region in the buttock suggests that the benets of glucocorticoid may arise independent of accuracy of needle placement. Therefore, although ultrasound guidance may improve the accuracy of injection to the putative site of pathology in the shoulder, it is not clear that this improves its efcacy to justify the signicant added cost.
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Implications for research

Our conclusions are based upon one trial at low risk of bias, and moderate quality evidence overall. Our condence in the estimate of effect is only limited due to the availability of a single low risk trial. If further comparative effectiveness trials to determine whether or not ultrasound guidance to direct glucocorticoid injection into the putative site of local pathology in the shoulder is superior to anatomic landmark guided injection or intramuscular injection are contemplated, these should consider the sample size required to change our conclusions. In addition to adequate randomisation and treatment allocation concealment, participant blinding is a necessary requirement. Trials should also measure
valid outcomes of importance to patients. A core set of outcomes for shoulder pain trials would enhance these efforts.
ACKNOWLEDGEMENTS
We would like to thank Louise Falzon, Search Specialist for the Cochrane Musculoskeletal Group, for designing the search strategy, and performing the search. We would like to thank Dr Juliana Roos who contributed to the drafting of the protocol. We would also like to thank Drs Ekeberg and Naredo who responded to our requests for further details with additional information about their trials.
REFERENCES
References to studies included in this review

Chen 2006 {published data only} Chen MJ, Lew HL, Hsu TC, Tsai WC, Lin WC, Tang SF, et al.Ultrasound-guided shoulder injections in the treatment of subacromial bursitis. American Journal of Physical Medicine and Rehabilitation 2006;1:315. Ekeberg 2009 {published data only} Ekeberg OM, Bautz-Holter E, Tveita EK, Juel NG, Kvalheim S, Brox JI, et al.Subacromial ultrasound guided or systemic steroid injection for rotator cuff disease: randomised double blind study. BMJ 2009;338:a3112. Lee 2009 {published data only} Lee H-J, Lim K-B, Kim D-Y, Lee K-T. Randomized controlled trial for efcacy of intra-articular injection for adhesive capsulitis: ultrasonography-guided versus blind technique. Archives of Physical Medicine & Rehabilitation 2009;90(12):19972002. Naredo 2004 {published data only} Naredo E, Cabero F, Beneyto P, Cruz A, Mondejar B, Uson J, et al.A randomized comparative study of short term response to blind injection versus sonographic-guided injection of local corticosteroids in patients with painful shoulder. Journal of Rheumatology 2004;31(2):30814. Ucuncu 2009 {published data only} Ucuncu F, Capkin E, Karkucak M, Ozden G, Cakirbay H, Tosun M, et al.A comparison of the effectiveness of landmark-guided injections and ultrasonography guided injections for shoulder pain. Clinical Journal of Pain 2009; 25(9):7869.
collaborative pilot study. Knee Surgery Sports Traumatology Arthroscopy 2006;14(12):13216. Bamji 2004 {published data only} Bamji AN. Treatment of shoulder pain. Annals of the Rheumatic Diseases 2004;63(5):607. [MEDLINE: ft] Buchbinder 2004 {published data only} Buchbinder R, Green S. Effect of arthrographic shoulder joint distension with saline and corticosteroid for adhesive capsulitis. British Journal of Sports Medicine 2004;38(4): 3845. Buchbinder R, Green S, Forbes A, Hall S, Lawler G. Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial. Annals of the Rheumatic Diseases 2004;63(3):3029. Chavez-Lopez 2009 {published data only} Chavez-Lopez MA, Navarro-Soltero LA, Naredo E, Gallaga A, Huerta-Yanez G, Avalos-Romero E, et al.Methilprednisolone vs triamcinolone in painful shoulder using ultrasound-guided injection: A randomized, prospective, double-blind study. Annals of the Rheumatic Diseases 2004;63:243. Chavez-Lopez MA, Navarro-Soltero LA, Rosas-Cabral A, Gallaga A, Huerta-Yanez G, Chavez-Lopez MA, et al.Methylprednisolone versus triamcinolone in painful shoulder using ultrasound-guided injection. Modern Rheumatology 2009;19(2):14750. [MEDLINE: ft; : 14397595] Cohen 2009 {published data only} Cohen SP, Strassels SA, Foster L, Marvel J, Williams K, Crooks M, et al.Comparison of uoroscopically guided and blind corticosteroid injections for greater trochanteric pain syndrome: multicentre randomised controlled trial. BMJ 2009;338(7701):9868.
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References to studies excluded from this review

Alfredson 2006 {published data only} Alfredson H, Harstad H, Haugen S, Ohberg L. Sclerosing polidocanol injections to treat chronic painful shoulder impingement syndrome - results of a two-centre
Esenyel 2003 {published data only} Esenyel CZ, Esenyel M, Yesiltepe R, Ayanoglu S, Bulbul M, Sirvanci M, et al.[The correlation between the accuracy of steroid injections and subsequent shoulder pain and function in subacromial impingement syndrome] [Subakromiyal sikisma sendromunda steroid enjeksiyonunun dogru sekilde uygulanmasi ile omuz agrisi ve fonksiyonu arasindaki iliski]. Acta Orthopaedica et Traumatologica Turcica 2003;37(1): 415. [MEDLINE: ft; : 1017995X] Gutierrez 2004 {published data only} Gutierrez G, Burroughs M. Does injection of steroidsand lidocaine in the shoulderrelieve bursitis?. Journal of Family Practice 2004;53(6):492. [MEDLINE: ft; : 00943509] Henkus 2006 {published data only} Henkus HE, Cobben LP, Coerkamp EG, Nelissen RG, van Arkel ER. The accuracy of subacromial injections: a prospective randomized magnetic resonance imaging study. Arthroscopy 2006;22(3):27782. [MEDLINE: ft] Kang 2008 {published data only} Kang MN, Rizio L, Prybicien M, Middlemas DA, Blacksin MF. The accuracy of subacromial corticosteroid injections: a comparison of multiple methods. Journal of Shoulder & Elbow Surgery 2008;17(1 Suppl):61S6S. Koes 2009 {published data only} Koes BW. Corticosteroid injection for rotator cuff disease: systemic injection of corticosteroid is as effective as local injection. BMJ 2009;338(7689):245. McCormack 2009 {published data only} McCormack R. Subacromial or systemic steroid injection for rotator cuff disease?. Clinical Journal of Sport Medicine 2009;19(6):5078. Rutten 2007 {published data only} Rutten M, Maresch BJ, Jager GJ, Malejt MCD. Injection of the subacromial-subdeltoid bursa: blind or ultrasoundguided?. Acta Orthopaedica 2007;78(2):2547. Sibbitt 2009 {published data only} Sibbitt WL Jr, Peisajovich A, Michael AA, Park KS, Sibbitt RR, Band PA, Bankhurst AD. Does sonographic needle guidance affect the clinical outcome of intraarticular injections?. Journal of Rheumatology 2009;36:1892902. Tveita 2008 {published data only} Tveita EK, Tariq R, Sesseng S, Juel NG, Bautz-Holter E. Hydrodilatation, corticosteroids and adhesive capsulitis: a randomized controlled trial. BMC Musculoskeletal Disorders 2008;9:53. Valtonen 1978 {published data only} Valtonen EJ. Double acting betamethasone (Celestone Chronodose) in the treatment of supraspinatus tendinitis: a comparison of subacromial and gluteal single injections with placebo. The Journal of International Medical Research 1978;6(6):4637. Widiastuti-Samekto 2004 {published data only} Widiastuti-Samekto M, Sianturi GP. Frozen shoulder syndrome: comparison of oral route corticosteroid and
intra-articular corticosteroid injection. Medical Journal of Malaysia 2004;59(3):3126. Yi 2006 {published data only} Yi TI, Kim ST, Kim DH, Kim JS, Park JS, Lee JH. Comparison of blind technique and ultrasonography guided technique of intraarticular injection of the shoulder. Journal of Korean Acadademic and Rehabilitation Medicine 2006;30: 4550.
References to studies awaiting assessment

Saeed 2010 {published data only} Saeed A, Khan M, Morrissey S, Fraser A. Clinic based MSK Ultrasound in the diagnosis and treatment of shoulder pain a randomized prospective study [abstract]. Rheumatology. 2010; Vol. Conference: Rheumatology 2010 British Society for Rheumatology, BSR and British Health Professionals in Rheumatology, BHPR Annual Meeting 2010 Birmingham United Kingdom. Conference Start: 20100420 Conference End: 20100423. Conference: Rheumatology 2010 British Society for Rheumatology, BSR and British Health Professionals in Rheumatology, BHPR Annual Meeting 2010 Birmingham United Kingdom. Conference Start: 20100420 Conference End: 20100423. Conference Publication: (var.pagings). 49:i24. Saeed A, Khan M, Morrissey S, Fraser AD. Clinic based MSK Ultrasound in the diagnosis and treatment of shoulder pain a randomized prospective study [abstract]. Arthritis and Rheumatism. 2010; Vol. 62 Suppl 10:2224.
Additional references
American Academy of Orthopedic Surgeons 2001 American Academy of Orthopedic Surgeons. AAOS clinical guidelines on shoulder pain. Rosemont, IL 2001. Arroll 2005 Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. British Journal of General Practice 2005;55(512):2248. Buchbinder 2003 Buchbinder R, Green S, Youd J. Corticosteroid injections for shoulder pain. Cochrane Database of Systematic Reviews 2003, Issue 1. [DOI: 10.1002/14651858.CD004016] Cates 2004 Cates, CD. Visual Rx NNT Calculator [Computer program]. Dr Chris Cates EBM website. Available from http://www.nntonline.net/ 2004. Deeks 2008 Deeks JJ, Higgins JPT, Altman DG (editors). Chapter 9: Analysing data and undertaking meta-analyses. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 (updated September 2008). The Cochrane Collaboration. Available from www.cochranehandbook.org. Eustace 1997 Eustace JA, Brophy DP, Gibney RP, Bresnihan B, FitzGerald O. Comparison of the accuracy of steroid placement with
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clinical outcome in patients with shoulder symptoms. Annals of the Rheumatic Diseases 1997;56(1):5963. Hall 2004 Hall S, Buchbinder R. Do imaging methods that guide needle placement improve outcome? [Editorial]. Annals of the Rheumatic Diseases 2004;63:10078. Hartung 2010 Hartung W, Ross CJ, Straub R, Feuerbach S, Schlmerich J, Fleck M, Herold T. Ultrasound-guided sacroiliac joint injection in patients with established sacroiliitis: precise IA injection veried by MRI scanning does not predict clinical outcome. Rheumatology 2010;49:147982. Higgins 2008 Higgins JPT, Altman DG (editors). Chapter 8: Assessing risk of bias in included studies. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 (updated September 2008). The Cochrane Collaboration. Available from www.cochrane-handbook.org. Iagnocco 2010 Iagnocco A, Naredo E. Ultrasound-guided corticosteroid injection inrheumatology: accuracy or efcacy? Is it the best way to deliver corticosteroid injections?. Rheumatology 2010;49(8):1427-8. Kane 2001 Kane D, Greaney T, Shanahan M, Duffy G, Bresnihan B, Gibney R, FitzGerald, O. The role of ultrasonography in the diagnosis and management of idiopathic plantar fasciitis. Rheumatology 2001;9:10028. Medicare Australia 2010 Medicare Australia. Medicare Item Reports: Medicare Australia, 2010. https://www.medicareaustralia.gov.au/ statistics/mbsitem.shtml. Micu 2010 Micu MC, Bogdan GD, Fodor D. Steroid injection for hip osteoarthritis: efcacy under ultrasound guidance. Rheumatology 2010;49:14904. Partington 1998 Partington PF, Broome GH. Diagnostic injection around the shoulder: hit and miss? A cadaveric study of injection accuracy. Journal of Shoulder and Elbow Surgery 1998;7(2): 14750. Pekarek 2011 Pekarek B, Osher L, Buck S, Bowen M. Intra-articular corticosteroid injections: A critical literature review with up-to-date ndings. Foot 2011;21(2):6670. Porat 2008 Porat S, Leupold JA, Burnett KR, Nottage WM. Reliability of non-imaging-guided glenohumeral joint injection through rotator interval approach in patients undergoing diagnostic MR arthrography. American Journal of Roentgenology 2008;191(3):W969.
Schnemann 2008a Schnemann HJ, Oxman AD, Higgins JPT, Vist GE, Glasziou P, Guyatt GH. Chapter 11: Presenting results and Summary of ndings tables. In Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 (updated September 2008). The Cochrane Collaboration. Available from www.cochranehandbook.org. Schnemann 2008b Schnemann HJ, Oxman AD, Vist GE, Higgins JPT, Deeks JJ, Glasziou P, Guyatt GH. Chapter 12: Interpreting results and drawing conclusions. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 (updated September 2008). The Cochrane Collaboration. Available from: www.cochranehandbook.org. Sethi 2005 Sethi PM, Kingston S, Elattrache N. Accuracy of anterior intra-articular injection of the glenohumeral joint. Arthroscopy 2005;21(1):7780. Shanahan 2004 Shanahan E, Smith M, Wetherall M, Lott C, Slavotinek J, FitzGerald O, Ahern, MJ. Suprascapular nerve block in chronic shoulder pain - are the radiologists better?. Annals of the Rheumatic Diseases 2004;63(9):103540. Soh 2011 Soh E, Li W, Ong KO, Chen W, Bautista D. Image-guided versus blind corticosteroid injections in adults with shoulder pain: A systematic review. BMC Musculoskeletal Disorders 2011;12:137. Taras 1998 Taras J, Raphael J, Pan W, Movagharnia F, Sotereanos D. Corticosteroid injections for trigger digits: is intrasheath injection necessary?. Journal of Hand Surgery [American] 1998;23:71722. White 1996 White AET, Tuite JD. The accuracy and efcacy of shoulder injections in restrictive capsulitis. Journal of Orthopaedic Rheumatology 1996;9:3740. Wood 2008 Wood L, Egger M, Gluud LL, Schulz KF, Jni P, Altman DG, Gluud C, Martin RM, Wood AJG. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes:meta-epidemiological study. BMJ 2008;336(7644):6015. Yamakado 2002 Yamakado K. The targeting accuracy of subacromial injection to the shoulder: an arthrographic evaluation. Arthroscopy 2002;18(8):88791. Indicates the major publication for the study
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CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]

Chen 2006 Methods Design: Parallel group, two-arm controlled clinical trial in participants with subacromial bursitis (Taiwan) Interventions: Ultrasound-guided or blind (anatomical landmark-guided) injection into subacromial bursa Sample size: Not reported Analysis: Only before-after analysis by group planned and reported Number of participants: 40 (20 per group) Baseline characteristics: Baseline characteristics by group were not reported. Mean (range) age: 53 (30-66) years Ratio of men:women = 2:1 Duration of symptoms: 2-10 months Inclusion criteria: 1. Shoulder pain for >1 month; and 2. shoulder pain that could be elicited during abduction manoeuvres; and 3. shoulder range of motion limitation and the existence of painful arc syndrome; and 4. sonographic conrmation of subacromial bursitis. Exclusion criteria: Capsular lesions of the shoulder. All participants had an ultrasound performed prior to the procedure. They were seated in an upright position with their back well supported and arms behind their backs with their elbows bent Both groups received a single injection of a suspension containing 1 ml of betamethasone and 1 ml of 1% lidocaine using a 21-gauge needle Ultrasound-guided injection (N=20): The needle was inserted into the subacromial bursa. Advancement of the need to the lesion site was observed as continuous and real-time images. The ultrasound-guided injections were performed by a physician experienced in using ultrasound probes and in reading musculoskeletal sonograms Anatomical landmark-guided injection (N=20): The acromion was palpated by the thumb and the needle inserted in a horizontal approach. The needle was adjusted in different depths and angles to try to aspirate the effusion. If no effusion could be aspirated, the physician injected the suspension into the subacromial bursa. The blind injection was performed by a physician experienced with peripheral joint and soft-tissue injections. Outcomes Outcome measured before and 1 week after the injection. Primary outcome 1, Shoulder abduction ROM in degrees measured using a universal goniometer (not specied if active or passive) No other outcomes were specied.
Participants
Interventions
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Chen 2006
(Continued)
Sources of funding Notes
No funding reported. It appears that a different physician performed the injections for each group following the ultrasound of the shoulder. It is not clear whether or not the physician who performed the blinded injections was present at the time of the ultrasound and/or was blinded to the ndings The baseline shoulder abduction ROM was reported to be 71.03 12.38 degrees, improving to 100 degrees 18.18 degrees at one week in the blinded injection group, and 69.05 14.72 degrees improving to 139.29 20.14 degrees at one week in the ultrasound-guided group. The authors reported that the before-after comparison was signicant in the ultrasound-guided group (P <0.05) but not the blinded injection group. No between group analysis was reported and it is unclear if variance estimates reported were SD or SE. We were unable to contact the trial authors so we assumed that SDs were reported for the purpose of pooling
Risk of bias Bias Authors judgement Support for judgement Quote: the patients were divided into blind and ultrasound-guided injection groups The method of division of patients into the two groups was not specied (no mention of randomisation or random sequence generation) The study does not report if or how sequence allocation was concealed The study does not report whether or not participants and/or personnel were blinded to treatment allocation The study does not report who measured the outcomes and whether or not they were aware of the patients allocated group The number of participants who completed the one week assessment was not reported Only range of shoulder abduction was reported to have been measured One physician performed all ultrasoundguided injections and a different physician performed all anatomic landmark-guided
23
Random sequence generation (selection Unclear risk bias)
Allocation concealment (selection bias)
Unclear risk
Blinding of participants and personnel Unclear risk (performance bias) All outcomes Blinding of outcome assessment (detection Unclear risk bias) All outcomes Incomplete outcome data (attrition bias) All outcomes Unclear risk
Selective reporting (reporting bias)
Unclear risk
Other bias
Unclear risk
Chen 2006
(Continued)
injections. If the expertise of these physicians differed then this could have biased the treatment effect estimates The baseline shoulder abduction ROM was slightly more restricted (worse) in the ultrasound-guided group which may have slightly biased the results in favour of the ultrasound-guided group
Ekeberg 2009 Methods Design: Parallel group, two-arm, double blind randomised controlled trial in participants with rotator cuff disease (Norway) Interventions: Ultrasound-guided corticosteroid and lidocaine injection in the subacromial bursa and lidocaine injection in the gluteal region (local group) or corticosteroid and lidocaine injection in the gluteal region and ultrasound-guided lidocaine injection in the subacromial bursa (systemic group) Sample size: 106 participants were estimated to be needed based upon detecting a clinically relevant difference of 10 points in the Shoulder Pain and Disability Index (SPADI)(SD=20) at 6 weeks with 95% probability and 80% power including a 10% rate of loss at follow-up Analysis: Intention to treat analysis planned. Number of participants: 106 (53 per group) Baseline characteristics: Local group (Image-guided steroid injection into the subacromial bursa): Mean (SD) age = 51 (11) years; M:F = 21:32 Duration of symptoms: <6months: 15 (28%); 6m-1yr: 17 (32%); 1-2yrs: 7 (13%); >2yrs: 14 (26%) Treatment history: Physiotherapy: 29 (55%); Corticosteroid injection: 22 (42%) Concurrent treatment: Physiotherapy: 9 (17%); Analgesics: 19 (36%) Systemic group (Steroid injection into the gluteal region): Mean (SD) age = 50 (12) years; M:F = 20:33 Duration of symptoms: <6months: 15 (28%); 6m-1yr: 15 (28%); 1-2yrs: 11 (21%); >2yrs: 12 (23%) Treatment history: Physiotherapy: 23 (43%); Corticosteroid injection: 20 (38%) Concurrent treatment: Physiotherapy: 6 (11%); Analgesics: 21 (40%) Inclusion Criteria: Patients with rotator cuff disease according to the following criteria: 1. Age > 18 years; and 2. shoulder pain for >3 months; and 3. pain on abduction; and 4. less than a 50% reduced glenohumeral range of motion in no more than one direction of external rotation, internal rotation or abduction; and 5. pain on two of three isometric tests for abduction, external rotation and internal rotation; and 6. positive Hawkins-Kennedy impingement sign.
Participants
Ekeberg 2009
(Continued)
Exclusion Criteria: 1. Symptomatic acromioclavicular arthritis; 2. clinical and radiological ndings indicating glenohumeral joint pathology; 3. referred pain from the neck or internal organs; 4. generalised muscular pain syndrome with bilateral muscular pain in the neck and shoulders; 5. a history of inammatory arthritis; 6. diabetes mellitus type 1; 7. previous fractures or surgery to the shoulder; 7. contraindications to local steroid injections; 8. receipt of any corticosteroids in the month before inclusion; 9. shoulder pain and disability index (SPADI) score < 30/100 Interventions All injections were performed in a standardised way by the same independent consultant physician who was responsible for preparing the syringes immediately before use according to the randomisation schedule The sonographically-guided injection into the subacromial bursa was performed rst, using commercial ultrasound equipment with a 5-9 MHz linear transducer for guidance. Patients sat facing the ultrasound screen with the affected arm rotated internally behind the back, elbow bent, and the back of the hand resting against the lower back. The physician used the ultrasound probe to visualise the insertion of the supraspinatus tendon and the subacromial bursa on the longitudinal axis, taking care that the contents of the syringes were never shown to the participants. She used the anterior approach with a 0. 850 mm intra-muscular needle for the subacromial injections, perforating the skin and tracking the needle in real time until it reached the subacromial bursa. She emptied the content of the syringe into the subacromial bursa, taking care to avoid direct injection into the rotator cuff tendons. The physician then gave patients the intramuscular injection in the upper gluteal region Local group (N=53): 2 ml (10 mg/ml) triamcinolone (Kenacort-T, Bristol-Myers Squibb) and 5 ml (10 mg/ ml) lidocaine hydrochloride (Xylocaine, AstraZeneca) to the subacromial bursa; and 4 ml (10 mg/ml) lidocaine hydrochloride to the upper gluteal region Systemic group (N=53): 5 ml (10 mg/ml) lidocaine hydrochloride to the subacromial bursa; and 2 ml (10 mg/ ml) triamcinolone and 2 ml (10 mg/ml) lidocaine hydrochloride to the upper gluteal region. Outcomes Outcomes were measured at baseline, 2 weeks and 6 weeks by a blinded assessor Primary outcome: 1. Shoulder pain and disability index (SPADI) (0-100 scale where a higher score indicates worse pain and/or disability)(primary endpoint at 6 weeks) Secondary outcomes: 2. Western Ontario Rotator Cuff Index (score range 0 (best score) to 100, or can also be reported as a percentage of normal) 3. Active range of abduction and exion, measured in degrees using an electronic digital inclinometer
25
Ekeberg 2009
(Continued)
4. The participants assessment of change in the main complaint compared with baseline, measured on an 18 point ordinal scale 5. Pain at rest (time period not specied) measured on a nine point ordinal scale (1 to 9 where 0= no pain) 6. Pain with activity (time period not specied) measured on a nine point ordinal scale (1 to 9 where 0 = no pain) Sources of funding Notes University of Oslo funded the study. Dr Ekeberg provided mean (SD) values for pain at rest, pain with activities, active abduction and exion for each treatment group at baseline, 2 and 6 weeks (as these data were not reported in the published paper). We extracted pain with activity for our analyses. Because a higher score in function measures in other trials indicated better function while a higher score on the SPADI indicates worse function we transformed the SPADI scores by subtracting the value from 100 for the purpose of pooling data in Analysis 1. However for the sensitivity analysis (Analysis 2), and presentation of results in the summary of ndings table, we presented the SPADI scores as reported in the trial The authors noted that there were no serious adverse events.
Risk of bias Bias Authors judgement Support for judgement Quote: We used the computer program Clinstat to generate a predetermined randomisation sequence with a randomised variable block size of three, four, and ve Quote: The consultant physician responsible for the injections held the only copy of the randomisation sequence. After the baseline registrations, we gave each participant a study number. To ensure concealed allocation, each patient was referred to the consultant physician responsible for injections, who then allocated the patient to one of the treatment groups according to the randomisation sequence Quote: Both groups received injections of local anaesthetic in the shoulder and the gluteal region. We provided local anaesthetic to improve blinding of participants by inducing a temporary pain relief (impingement test) and mask possible post-injection pain. The physician performing the injection was not blinded.
Random sequence generation (selection Low risk bias)
Low risk
Blinding of participants and personnel Low risk (performance bias) All outcomes
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Ekeberg 2009
(Continued)
Blinding of outcome assessment (detection Low risk bias) All outcomes Incomplete outcome data (attrition bias) All outcomes Low risk
Quote: Patients ... were assessed by the same physician (OME) blinded for treatment group All 53 patients in the local group completed follow-up. 2/53 in the systemic group were not available for follow up at 6 weeks - one due to a medical condition and the other was unable to be contacted. These losses to follow up were reported and analysed on an intention-to-treat basis All proposed outcomes are reported in the results. No evidence of any other bias.
Low risk
Other bias
Low risk
Lee 2009 Methods Design: Parallel group, two-arm controlled clinical trial in participants with adhesive capsulitis (South Korea) Interventions: Ultrasound-guided or blind (anatomical landmark-guided) intra-articular injection of 0.5mL intra-articular injection of triamcinolone (20mg) mixed with 1. 5mL of 2% lidocaine and 3mL of normal saline, followed by 5 x2.5mL injections of lowmolecular-weight sodium hyaluronate (25mg) at weekly intervals by the same approach Sample size: Not specied Analysis: Intention to treat analysis not specied Number of participants: 43 (21 ultrasound-guided and 22 anatomical landmark guided) Baseline characteristics: Mean (SD) age: 53.1 (7.3) years in the ultrasound-guided group and 54.1 (7.74) years in the blind group Male:female ratio 9:11 in the ultrasound-guided group and 10:10 in the blind group Average duration of shoulder pain: 8.5 months for the ultrasound-guided group and 10. 6 months in the blind group Five participants in the ultrasound-guided group had diabetes compared with three in the blind group Inclusion criteria: Diagnosis of clinical disease stage II idiopathic adhesive capsulitis on the basis of 1. Main complaint of limited range of movement of the shoulder joint and pain; and 2. normal X rays of the shoulder joint; and 3. ultrasound of the shoulder showing no particular problems such as rotator cuff injury, calcic tendinopathy, and subacromial bursitis Exclusion Criteria: 1. Other disorders that can cause similar clinical symptoms
Participants
Lee 2009
(Continued)
2. Cervical examination showing signicant dysfunction suggestive of cervical disk disorder or radiculopathy; 3. Ultrasound showing rotator cuff injury, calcic tendinopathy or subacromial bursitis Interventions Both groups received a 0.5mL intra-articular injection of triamcinolone (20mg) mixed with 1.5mL of 2% lidocaine and 3mL of normal saline in the rst week. This was followed by a 2.5mL injection of low-molecular-weight sodium hyaluronate (25mg) in the second week and then once weekly for the next 4 weeks for a total of 5 hyaluronate injections The posterior approach was used for both groups. Patients were seated on a chair, with the affected shoulder bent and adducted Image-guided injection (N=21): The probe touched the lower part of the acromion sideways, and a long needle (23G, 7cm) was inserted to the posterior articular surface of the humeral head and positioned inside the articular capsule. The expansion of the articular capsule was checked while the uid was being injected. All image-guided injections were performed by one doctor with two years experience in ultrasound-guided shoulder injections Blind injection (N=22): The acromion of the scapula was palpated and the needle inserted 1cm inferior to the tip of the acromion. The needle was directed toward the coracoid process and advanced into the articular capsule, after which the drug was injected. All anatomic landmarkguided injections were performed by one doctor with seven years experience in anatomic landmark-guided shoulder injections Additional treatment in both groups: Both groups were taught exercises for increasing joint ROM including stretching forward and bending down to a desk, Codman exercise, and a wall-climbing exercise with the ngers. They were instructed to practice these at home and then checked and encouraged to keep up with the exercises every time they visited the hospital Outcomes All outcomes were measured at baseline and 1, 2, 3, 4, 5, 6 weeks. No primary outcome was specied Outcomes: 1. Intensity of shoulder pain in the daytime (time period not specied) measured on a VAS (scale not specied) 2. Intensity of shoulder pain just before sleep (time period not specied) measured on a VAS (scale not specied) 3. Passive abduction, exion, extension, internal and external rotation, measured in degrees using universal goniometer 4. Functional activities of the shoulder which evaluates pain intensity while the patient performs ten common functional activities in daily life (putting on clothes, combing hair with the affected arm, using a spoon and chopsticks during a meal, writing or typing on keyboards, carrying a handbag, cleaning the anus, catching something overhead, putting a hand on the back, doing routine sports, and sleeping on the painful side). Each function is evaluated on a 0 to 4 scale where 4 = normal condition, 3 = slight difculty, 2 = considerable difculty, 1 = requires help and 0 = impossible to perform the function), total score out of 40 with higher score indicating better function
Lee 2009
(Continued)
No funding specied. For the purpose of the review we only included the 1-week outcome data due to cointervention in both groups with ve intra-articular injections of 2.5mls low-molecularweight sodium hyaluronate (25mg) at weekly intervals after this time point
Risk of bias Bias Authors judgement Support for judgement Quote: They were alternately assigned to either US-guided injection or blind injection groups in the sequence in which they joined the study. As participants were alternately allocated into groups (see above), allocation was not concealed Quote: To mimic injection under the guidance of US, we rst contacted the patients in the blind injection group by an ultrasound probe at the skin under the acromion before the intra-articular injection Personnel performing the injections were not blinded but were not involved in outcome assessment Quote: One tester, who did not know which patient belonged to which group, performed the evaluations before and after treatment 2/22 in the blind group and 1/21 in the ultrasound-guided group did not complete the 6-week follow up. Reasons for noncompletion were not given. The number of participants who provided data at other time points (1, 2, 3, 4 and 5 weeks) was not reported. Baseline characteristics were only provided for participants who completed the 6-week follow up All the outcomes listed in the methods were reported.
Random sequence generation (selection High risk bias)
High risk
Blinding of participants and personnel Low risk (performance bias) All outcomes
Blinding of outcome assessment (detection Low risk bias) All outcomes
Incomplete outcome data (attrition bias) All outcomes
Low risk
Low risk
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Lee 2009
(Continued)
Other bias
Unclear risk
One physician performed all ultrasoundguided injections and a different physician performed all anatomic landmark-guided injections. If the expertise of these physicians differed then this could have biased the treatment effect estimates
Naredo 2004 Methods Design: Parallel group, two-arm randomised controlled trial and participants with periarticular disorders of the shoulder (impingement syndrome, rotator cuff lesions, subacromial-subdeltoid bursitis, and/or biceps tendon abnormalities)(Spain) Interventions: Anatomical landmark-guided injection of 20 mg triamcinolone into the subacromial space or ultrasound-guided injection of 20 mg triamcinolone into either the subacromial-subdeltoid bursa, biceps tendon sheath or rotator cuff calcications depending upon the ultrasound ndings Sample size: Not specied Analysis: Intention to treat analysis not specied Participants: 41 (20 in the ultrasound-guided group and 21 in the landmark-guided group) Baseline characteristics: Anatomic landmark-guided group Mean (SD) age: 51.9 (13.8) years Male:female ratio: 8:12 Mean (SD) symptom duration: 10.2 (14.7) months Ultrasound-guided group Mean (SD) age: 52.9 (11) years Male:Female ratio: 6:15 Mean (SD) symptom duration: 11.9 months (14.6) months Inclusion criteria: 1. First are of shoulder pain of periarticular etiology (impingement syndrome, rotator cuff lesions, subacromial-subdeltoid bursitis, and/or biceps tendon abnormalities) diagnosed by clinical history and examination 2. At least one month duration 3. Without response to nonsteroidal antiinammatory drugs Exclusion criteria: 1. chronic inammatory arthritis, previous trauma, fracture, glenohumeral osteoarthritis, bone tumours, osteonecrosis or other bone conditions 2. previous physiotherapy or local corticosteroid injections in the same shoulder 3. local corticosteroid injections in any musculoskeletal location in the three months prior to the study Interventions Prior to injection, all patients underwent a sonographic examination of their shoulders. All participants received a single injection with a 21-gauge needle, containing 20mg of triamcinolone. A single rheumatologist experienced in ultrasound performed all injec30
Participants
Naredo 2004
(Continued)
tions in both groups, without knowledge of the clinical evaluation Anatomic landmark-guided group (N=21): Access to the subacromial space was achieved with a lateral approach, inserting the needle under the anterolateral aspect of the acromion process, passing it through the deltoid muscle, and directing it medially and slightly anterior to the subacromial-subdeltoid (SA-SD) bursa, with care taken to avoid injection directly into the tendons of the rotator cuff Ultrasound-guided injection group (N=20): The needle was placed under the probe and its route was visualized in real-time by US, as a hyperreective line, often with reverberation, from the skin to the target. Injection was directed into the subacromial-subdeltoid (SA-SD) bursa or biceps tendon sheath when increased uid was detected. When there was effusion in both the SA-SD bursa and the biceps tendon sheath, injection was directed into the SA-SD bursa due to its easier approach. Peri and intralesional injection was performed when rotator cuff calcications were found. Perilesional injection directed into the SA-SD bursa was performed when tendon lesions without increased uid were detected, avoiding direct injection into the rotator cuff tendons. Corticosteroid injection was sonographically guided to the SA-SD bursa in 14 patients, to biceps tendon sheath in 3 patients, and to rotator cuff calcication in 4 patients. Postinjection steroid location was conrmed by US in all patients Both groups: No patient received physical therapy during the followup period. However, patients with loss of shoulder ROM were instructed to start a home physical therapy program consisting of pendulum exercises and slow shoulder abduction. No restriction was placed on the patients ability to work or to use their shoulder as tolerated, or on NSAID intake Outcomes Outcomes were measured at baseline (within 5 days of intervention) and at 6-week follow-up. No primary outcome was specied Outcomes: 1. Pain during the previous week measured with a VAS (0 to 100mm scale, 0mm= no pain, 100mm=maximum pain)(type of pain, e.g., overall, activity, night pain not specied) 2. Shoulder Function Assessment (SFA) scale: This scale has two 2 items concerning pain on motion and at rest, four multiple choice items for shoulder function in activities of daily living (dressing, combing hair, washing opposite axilla, and using the toilet), and three objective ROM measures (active abduction measure (1 point per 10 of abduction, score: 0-18) and 2 semi-quantitative measures of combined movements). The overall score ranges 0 (maximum pain, maximum shoulder function impairment, and maximum motion loss) to 70 points (no pain, normal shoulder function and motion) 3. Presence of nocturnal pain 4. Intake of NSAID 5. The number of patients with a 50% improvement in VAS was calculated for each group 6. The number of patients with a 50% improvement in SFA score was calculated for each group 7. The active and passive ROM of the shoulder was subjectively assessed for exion, abduction, and internal and external rotation. A goniometer was used for measuring active abduction. The degree of impairment of the other movements was not measured. 8. Postinjection adverse effects (immediate or delayed).
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Naredo 2004
(Continued)
None reported. The SD for the mean duration of symptoms was larger than the mean duration of symptoms in both treatment groups The baseline (SD) and mean change (SD) scores were reported for each group but the nal 6-week mean scores were only presented graphically. We used Figure 5 and the change scores to estimate mean 6-week pain and function scores. We estimated the SD for the mean scores at 6 weeks using a formula that considers the SD of baseline means and change means and a correlation coefcient to allow for the correlation between baseline and 6-week scores. For the landmark/systemic group, the correlation was >0. 91 for the VAS (pain) and >0.82 for SFA (function). For the image-guided group, a correlation of 0.5 was used for both outcomes Dr Naredo conrmed that participants were not blinded to treatment allocation but was unable to provide further details regarding the analysis
Risk of bias Bias Authors judgement Support for judgement Quote: Patients were randomized by a random-number sequence.. Treatment allocation was performed by an independent rheumatologist, without knowledge of the clinical evaluation The study does not report whether or not participants were blinded to treatment allocation Personnel giving the intervention were aware of group allocation Quote: Each patient was reviewed 6 weeks post injection by the same rheumatologist who performed the initial clinical evaluation (FC), blinded to the injection technique and the sonographic ndings. The study provides no information on whether or not any participants were lost to follow-up For ROM, only results for whether or not participants had active abduction impairment were reported. No goniometer measures were reported and no results for active exion and internal and external rotation were provided
32
Random sequence generation (selection Low risk bias) Allocation concealment (selection bias) Low risk
Blinding of participants and personnel High risk (performance bias) All outcomes
Blinding of outcome assessment (detection Low risk bias) All outcomes
Unclear risk
Unclear risk
Naredo 2004
(Continued)
Other bias
Low risk
No evidence of any other bias.
Ucuncu 2009 Methods Design: Parallel group, two-arm randomised controlled trial in participants with soft tissue shoulder lesions (acromioclavicular degeneration, rotator cuff lesions (rupture, partial rupture, tendinosis, impingement, calcication) uid accumulation in the biceps tendon, partial rupture in the biceps tendon and bursitis (subdeltoid, subacromial)) (Turkey) Interventions: Triamcinolone (40 mg) either by landmark-guided injection into the subacromial region or ultrasound-guided injection perilesionally and intralesionally (site not specied further) Sample size: Not reported Analysis: Intention to treat analysis not specied Participants: 60 (30 in each group) Baseline characteristics: Landmark-guided injection group: Mean (SD) age: 52.9 (9.7) years Male: Female ration: 8:22 Mean (SD) symptom duration: 9.6 (8.7) months Ultrasound-guided injection group: Mean (SD) age: 52.1 (11.6) years Male: Female ration: 8:22 Mean (SD) symptom duration: 10.7 (12.5) months Inclusion criteria: 1. Shoulder pain for at least 1 month and not satisfactorily responding to at least 1 month of nonsteroidal antiinammatory drugs Exclusion criteria: 1. chronic inammatory arthritis (i.e., rheumatoid arthritis, ankylosing spondylitis); 2. diabetes mellitus; 3. previously major trauma in shoulder area; 4. pain in both shoulders; 5. receipt of previous physical therapy or local steroid injections Interventions All participants were examined with ultrasound, performed by a physician experienced in US without knowledge of the clinical evaluation. All participants received a single injection of 1 mL 40 mg triamcinolone and 1 mL 1% lidocaine Ultrasound-guided injection (N=30): The injector was directed to the target beneath the probe by imaging a hyper-reective line. Injectates were administered perilesionally and intralesionally Landmark-guided injection (N=30): Blind injection was administered with a lateral entry approach to the sub-acromial region. Both groups: The patients did not receive physical therapy during the follow-up period. Patients with
Participants
Ucuncu 2009
(Continued)
shoulder range of motion (ROM) loss performed a home exercise program consisting of shoulder abduction and pendulum exercises. No limit was imposed on nonsteroid antiinammatory consumption or use of the shoulder to the extent tolerable. Outcomes Outcomes were measured at baseline and 6-weeks following injection. No primary endpoint was specied Outcomes: 1. Pain (type of pain and time period not specied) measured on a VAS (0 to 10 scale) 2. Shoulder function was measured with the Constant scale. This test examines shoulder pain, impact of injury on activities of daily living, range of movement and power. Scale is 0-100 with a higher score indicating increased shoulder functionality 3. Active and passive shoulder exion in the supine and shoulder abduction in the sitting position were evaluated using goniometry 4. Early and late stage injection side-effects. Sources of funding Notes None reported. The study provided no information on numbers analysed in each group or loss to followup Baseline function was signicantly worse in the ultrasound-guided group
Risk of bias Bias Authors judgement Support for judgement Quote: This prospective randomized study allocated consecutive patients, stratied by sex to either LMG group or USG group. Method of random sequence generation not specied. Allocation concealment (selection bias) Unclear risk Study does not state if allocation concealment was occurred. Participants were not blinded. The study does not report whether or not personnel were blinded to treatment allocation The study does not provide details about who performed the outcome assessment and whether or not they were blinded to treatment allocation
Random sequence generation (selection Unclear risk bias)
Blinding of participants and personnel High risk (performance bias) All outcomes Blinding of outcome assessment (detection Unclear risk bias) All outcomes
34
Ucuncu 2009
(Continued)
Unclear risk
The study does not report whether or not all participants were included in the analysis All proposed outcomes are reported in the results. The study does not provide any details about who performed the injections and whether or not the same person performed injections for both groups Baseline function as measured by the Constant score was signicantly worse in the ultrasound-guided group versus the landmark-guided group which may have biased the result in favour of the ultrasoundguided group
Low risk
Other bias
Unclear risk
Characteristics of excluded studies [ordered by study ID]
Study Alfredson 2006 Bamji 2004 Buchbinder 2004 Chavez-Lopez 2009 Cohen 2009 Esenyel 2003 Gutierrez 2004 Henkus 2006 Kang 2008 Koes 2009 McCormack 2009 Rutten 2007
Reason for exclusion Not RCT Not RCT Not correct intervention Not correct comparator Not correct participants Not RCT (single arm before-after study) Not RCT Not correct intervention Not correct intervention Not RCT Not RCT RCT but only accuracy outcomes
35
(Continued)
Sibbitt 2009 Tveita 2008 Valtonen 1978
Not correct participants Not correct comparator First 60 patients given subacromial steroid injection, next 30 given intramuscular gluteal steroid injection and nal 90 patients randomly allocated by birth date to either subacromial steroid injection (N=30) , intramuscular gluteal steroid injection (N=30) or intramuscular gluteal placebo injection (N=30). However data for randomly allocated patients not presented separately Not correct intervention Not RCT (All patients with hemiplegia diagnosed with adhesive capsulitis received serial intra-articular injections with both blind and ultrasound guided technique)
Widiastuti-Samekto 2004 Yi 2006
Characteristics of studies awaiting assessment [ordered by study ID]

Saeed 2010 Methods Participants Randomised controlled trial N = 100 participants (125 shoulders) with painful shoulder enrolled; 80 participants with 90 symptomatic shoulders (46 blinded and 44 guided groups) completed the study. Mean age 57.7 years, 65% female; mean shoulder pain duration was 18 weeks (14-22) Group 1 (n = 66): sonographic assessment and blind subacromial injection of 40mg depomedrone Group 2 (n = 59): sonographic assessment and guided injection of 40mg depomedrone Outcomes measured at: baseline, 6 and 12 weeks: 1) Shoulder function: Hawkin-Kennedy test; 2) supraspinatous tendon tenderness; 3) patient global visual analogue score (VAS) for pain (0- 10); and 4) physician global visual analogue score (VAS) for pain (0- 10) The trial authors report that shoulder function improved signicantly from baseline in both groups at 6 and 12 weeks, with signicantly greater improvements at both time points in the guided vs the blind injection groups respectively. Patient VAS pain scores and physician global assessment for pain also improved signicantly in both groups at 6 and 12 weeks; improvements were signicantly greater at both time intervals in the guided group P<0.05 As the data is available only in an abstract from conference proceedings, with no mean and standard deviations reported for each treatment group, there is insufcient data for the review authors to verify the reported results
Interventions
Outcomes
Notes
36
DATA AND ANALYSES
Comparison 1. Ultrasound-guided injection versus landmark or systemic injection
Outcome or subgroup title 1 Overall pain (or daytime, activity-related or unspecied) 1.1 1-2 weeks 1.2 6 weeks 2 Function 2.1 1-2 weeks 2.2 6 weeks 3 Proportion of patients showing 50% improvement at 6 weeks 3.1 Pain 3.2 Function 4 Range of abduction 4.1 1-2 weeks 4.2 6 weeks 5 Range of exion 5.1 1-2 weeks 5.2 6 weeks 6 Number of adverse events 6.1 6 weeks
No. of studies 4 2 3 4 2 3 1 1 1 4 3 2 3 2 2 3 3
No. of participants
Statistical method Std. Mean Difference (IV, Random, 95% CI)
Effect size Subtotals only -1.44 [-4.14, 1.26] -0.80 [-1.46, -0.14] Subtotals only 0.95 [-1.29, 3.20] 0.63 [-0.06, 1.33] Totals not selected 0.0 [0.0, 0.0] 0.0 [0.0, 0.0] Subtotals only 19.77 [4.29, 35.26] 6.45 [-3.24, 16.15] 0.39 [-0.02, 0.80] 0.74 [-0.16, 1.65] 0.14 [-0.16, 0.45] Subtotals only 0.55 [0.17, 1.85]
146 207 146 207
Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Risk Ratio (M-H, Random, 95% CI) Risk Ratio (M-H, Random, 95% CI)
186 166 312 146 166 207
Comparison 2. Sensitivity analysis (adequate treatment allocation concealment, and blinding)
Outcome or subgroup title 1 Overall Pain 1.1 1-2 weeks 1.2 6 weeks 2 Function 2.1 1-2 weeks 2.2 6 weeks
No. of studies 1 1 1 1 1 1
No. of participants
Statistical method Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI)
Effect size Totals not selected 0.0 [0.0, 0.0] 0.0 [0.0, 0.0] Totals not selected 0.0 [0.0, 0.0] 0.0 [0.0, 0.0]
37
Analysis 1.1. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 1 Overall pain (or daytime, activity-related or unspecied).
Review: Image-guided versus blind glucocorticoid injection for shoulder pain
Comparison: 1 Ultrasound-guided injection versus landmark or systemic injection Outcome: 1 Overall pain (or daytime, activity-related or unspecied)
Study or subgroup
Image-guided N Mean(SD)
Landmark or systemic N Mean(SD)
Std. Mean Difference IV,Random,95% CI
Weight
1 1-2 weeks Lee 2009 Ekeberg 2009 20 53 3.6 (0.3) 4.3 (2.1) 20 53 4.8 (0.5) 4.5 (2.1) 48.8 % 51.2 % -2.85 [ -3.76, -1.95 ] -0.09 [ -0.48, 0.29 ]
Subtotal (95% CI)
73
73
100.0 %
-1.44 [ -4.14, 1.26 ]
Heterogeneity: Tau2 = 3.68; Chi2 = 30.35, df = 1 (P<0.00001); I2 =97% Test for overall effect: Z = 1.05 (P = 0.30) 2 6 weeks Naredo 2004 Ucuncu 2009 Ekeberg 2009 21 30 53 26.3 (21.4) 2.27 (1.94) 4 (2.2) 20 30 53 56.6 (18.9) 3.77 (1.65) 4.6 (2.2) 28.9 % 33.6 % 37.5 % -1.47 [ -2.17, -0.77 ] -0.82 [ -1.35, -0.29 ] -0.27 [ -0.65, 0.11 ]
Subtotal (95% CI)
104
103
100.0 % -0.80 [ -1.46, -0.14 ]
Heterogeneity: Tau2 = 0.26; Chi2 = 9.45, df = 2 (P = 0.01); I2 =79% Test for overall effect: Z = 2.39 (P = 0.017)
-2
-1
Favours image-guided
Favours landmark/systemic
38
Analysis 1.2. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 2 Function.
Comparison: 1 Ultrasound-guided injection versus landmark or systemic injection Outcome: 2 Function
Study or subgroup
Ultrasound-guided N Mean(SD)
Weight
1 1-2 weeks Ekeberg 2009 Lee 2009 53 20 68 (25) 31.1 (2.2) 53 20 72 (23) 27.1 (1.4) 51.2 % 48.8 % -0.17 [ -0.55, 0.22 ] 2.13 [ 1.34, 2.92 ]
Subtotal (95% CI)

Test for overall effect: Z = 0.83 (P = 0.41) 2 6 weeks Ekeberg 2009 Naredo 2004 Ucuncu 2009
73
73
100.0 % 0.95 [ -1.29, 3.20 ]
Heterogeneity: Tau2 = 2.53; Chi2 = 26.18, df = 1 (P<0.00001); I2 =96%
53 21 30
71 (21) 57.6 (13.2) 89 (13.1)
53 20 30
68 (23) 39.3 (11.1) 82.2 (16.5)
36.9 % 29.3 % 33.8 %
0.14 [ -0.25, 0.52 ] 1.47 [ 0.77, 2.17 ] 0.45 [ -0.06, 0.96 ]
Subtotal (95% CI)
104
103
100.0 % 0.63 [ -0.06, 1.33 ]
-4
-2
Favours ultrasound-guided
39
Analysis 1.3. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 3 Proportion of patients showing 50% improvement at 6 weeks.
Comparison: 1 Ultrasound-guided injection versus landmark or systemic injection Outcome: 3 Proportion of patients showing 50% improvement at 6 weeks
Study or subgroup
Ultrasound n/N
Landmark or systemic n/N
Risk Ratio M-H,Fixed,95% CI
Risk Ratio M-H,Fixed,95% CI
1 Pain Naredo 2004 2 Function Naredo 2004 5/21 2/20 2.38 [ 0.52, 10.90 ] 11/21 1/20 10.48 [ 1.49, 73.88 ]
0.001 0.01 0.1 Favours landmark-guided
10 100 1000 Favours ultrasound-guided
40
Analysis 1.4. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 4 Range of abduction.
Comparison: 1 Ultrasound-guided injection versus landmark or systemic injection Outcome: 4 Range of abduction
Study or subgroup
Mean Difference IV,Random,95% CI
Weight
1 1-2 weeks Chen 2006 Ekeberg 2009 Lee 2009 20 53 20 139.29 (20.14) 131.8 (26.8) 126.1 (4.6) 20 53 20 100 (18.18) 122.2 (31.6) 113.9 (5.8) 31.0 % 31.7 % 37.3 % 39.29 [ 27.40, 51.18 ] 9.60 [ -1.56, 20.76 ] 12.20 [ 8.96, 15.44 ]
Subtotal (95% CI)
93
93
100.0 % 19.77 [ 4.29, 35.26 ]
Heterogeneity: Tau2 = 164.53; Chi2 = 19.13, df = 2 (P = 0.00007); I2 =90% Test for overall effect: Z = 2.50 (P = 0.012) 2 6 weeks Ekeberg 2009 Ucuncu 2009 53 30 127.9 (32.2) 157 (21.8) 53 30 116.3 (33.4) 155.3 (25) 48.0 % 52.0 % 11.60 [ -0.89, 24.09 ] 1.70 [ -10.17, 13.57 ]
Subtotal (95% CI)
83
83
100.0 %
6.45 [ -3.24, 16.15 ]
-100
-50
50
100
41
Analysis 1.5. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 5 Range of exion.
Comparison: 1 Ultrasound-guided injection versus landmark or systemic injection Outcome: 5 Range of exion
Study or subgroup
Weight
1 1-2 weeks Ekeberg 2009 Lee 2009 53 20 150.2 (24.5) 130.9 (4.9) 53 20 141.6 (27.8) 123.9 (6) 28.6 % 18.5 % 0.33 [ -0.06, 0.71 ] 1.25 [ 0.57, 1.94 ]
Subtotal (95% CI)
73
73
47.2 %
0.74 [ -0.16, 1.65 ]
Heterogeneity: Tau2 = 0.35; Chi2 = 5.37, df = 1 (P = 0.02); I2 =81% Test for overall effect: Z = 1.61 (P = 0.11) 2 6 weeks Ekeberg 2009 Ucuncu 2009 53 30 148.1 (28.8) 156.6 (22.1) 53 30 140.5 (33.4) 157.3 (22.2) 28.7 % 24.2 % 0.24 [ -0.14, 0.62 ] -0.03 [ -0.54, 0.47 ]
Subtotal (95% CI)
83
83
52.8 %
0.14 [ -0.16, 0.45 ]
Heterogeneity: Tau2 = 0.0; Chi2 = 0.71, df = 1 (P = 0.40); I2 =0.0% Test for overall effect: Z = 0.92 (P = 0.36)
Total (95% CI)
156
156
100.0 %
0.39 [ -0.02, 0.80 ]
Heterogeneity: Tau2 = 0.11; Chi2 = 9.15, df = 3 (P = 0.03); I2 =67% Test for overall effect: Z = 1.85 (P = 0.064) Test for subgroup differences: Chi2 = 1.53, df = 1 (P = 0.22), I2 =35%
-4
-2
Favours control
Favours experimental
42
Analysis 1.6. Comparison 1 Ultrasound-guided injection versus landmark or systemic injection, Outcome 6 Number of adverse events.
Comparison: 1 Ultrasound-guided injection versus landmark or systemic injection Outcome: 6 Number of adverse events
Study or subgroup
Image-guided n/N
Landmark or systemic n/N
Risk Ratio MH,Random,95% CI
Weight
Risk Ratio MH,Random,95% CI
1 6 weeks Ekeberg 2009 Naredo 2004 Ucuncu 2009 9/53 0/21 1/30 9/53 1/20 6/30 62.4 % 12.7 % 24.9 % 1.00 [ 0.43, 2.32 ] 0.32 [ 0.01, 7.38 ] 0.17 [ 0.02, 1.30 ]
Subtotal (95% CI)
104
103
100.0 %
0.55 [ 0.17, 1.85 ]
Total events: 10 (Image-guided), 16 (Landmark or systemic) Heterogeneity: Tau2 = 0.42; Chi2 = 2.93, df = 2 (P = 0.23); I2 =32% Test for overall effect: Z = 0.96 (P = 0.34)
0.01
0.1
10
100
Favours image-guided
43
Analysis 2.1. Comparison 2 Sensitivity analysis (adequate treatment allocation concealment, and blinding), Outcome 1 Overall Pain.
Comparison: 2 Sensitivity analysis (adequate treatment allocation concealment, and blinding) Outcome: 1 Overall Pain
Study or subgroup
Favours ultrasoundguided N Mean(SD)
1 1-2 weeks Ekeberg 2009 2 6 weeks Ekeberg 2009 53 4 (2.2) 53 4.6 (2.2) -0.60 [ -1.44, 0.24 ] 53 4.3 (2.1) 53 4.5 (2.3) -0.20 [ -1.04, 0.64 ]
-2
-1
Analysis 2.2. Comparison 2 Sensitivity analysis (adequate treatment allocation concealment, and blinding), Outcome 2 Function.
Comparison: 2 Sensitivity analysis (adequate treatment allocation concealment, and blinding) Outcome: 2 Function
Study or subgroup
Ultrasound-guided N Mean(SD)
1 1-2 weeks Ekeberg 2009 2 6 weeks Ekeberg 2009 53 29 (21) 53 32 (23) -3.00 [ -11.38, 5.38 ] 53 32 (25) 53 28 (23) 4.00 [ -5.15, 13.15 ]
-20
-10
10
20
44
ADDITIONAL TABLES
Table 1. Characteristics of included trials N Study population Ultrasoundguided injection Landmark-guided Content of injec- Outcomes injection tion Subacromial bursa by one physician experienced in peripheral joint and softtissue injections Both groups re- 1. Range of abducceived 1ml tion betamethasone and 1ml 1% lignocaine
Chen 2006 (Taiwan) CCT
40
Ultrasound-conSubacromial bursa rmed subacromial by one physician bursitis experienced using ultrasound probes
Ekeberg 2009 106 (Norway) RCT
Rotator cuff disease Subacromial bursa Intramusby single physician cular injection upper gluteal region by same physician
Local group: 2ml (20mg) triamcinolone and 5ml (10mg/ml) lidocaine to subacromial bursa and 4ml (10mg/ml) lidocaine to gluteal Systemic group: 5ml (10mg/ ml) lidocaine to subacromial bursa and 2ml (20mg) triamcinolone and 2ml (10mg/ml) lidocaine to gluteal Both groups received 0. 5ml (20mg) triamcinolone and 1.5ml 2% lidocaine and 3ml normal saline
1. SPADI 2. Western Ontario Rotator Cuff Index 3. Active abduction and exion 4. Self-assessment of change in main complaint 5. Pain at rest 6. Pain with activity 7. Adverse events
Lee 2009 (South Korea) CCT
43
Adhesive capsulitis
Intraarticular injection into the glenohumeral joint by one physician with two years experience in ultrasoundguided shoulder injections
Intraarticular injection by one physician with 7 years experience in anatomic landmark-guided shoulder injections
1. Pain in daytime 2. Pain just before sleep 3. Passive abduction, exion, extension, internal and external rotation 4. Functional activities of the shoulder 1. Pain in previous week 2. Shoulder Function Assessment (SFA) scale 3. Presence of nocturnal pain 4. Intake of NSAIDs 5. Number of par-
Naredo (Spain) RCT
2004 41
Periarticular disorders (impingement syndrome rotator cuff lesions, subacromialsubdeltoid bursitis and/or biceps tendon abnormalities)
Either Subacromial space Bother groups resubacromial-subby same rheuma- ceived 20mg triamdeltoid bursa, bi- tologist cinolone ceps tendon sheath or rotator cuff calcications according to ultrasound ndings by single rheumatologists experienced in ultra-
45
Table 1. Characteristics of included trials
(Continued)
sound
ticipants 50% improvement in pain 6. Number of participants 50% improvement in SFA score 7. Active and passive abduction, exion, internal and external rotation 8. Adverse effects Both groups received 1ml (40mg) triamcinolone and 1ml 1% lidocaine 1. Pain 2. Constant score 3. Active and passive abduction and exion 4. Adverse events
Ucuncu 2009 (Turkey) RCT
60
Soft-tissue lesions (acromioclavicular degeneration, rotator cuff lesions (rupture, partial rupture, tendinosis, impingement, calcication), uid accumulation or partial rupture of biceps tendon and bursitis (subdeltoid, subacromial)
Perilesionally and Subacromial reintralesiongion; personnel not ally; personnel not specied specied
APPENDICES Appendix 1. MEDLINE search strategy

1. Shoulder Pain/ 2. Shoulder Impingement Syndrome/ 3. Rotator Cuff/ 4. exp Bursitis/ 5. exp PAIN/ 6. exp Shoulder Joint/ 7. 5 and 6 8. ((should$ or rotator cuff ) adj5 (bursitis or adhesive capsulitis or periarthriti$ or frozen or impinge$ or tend?nitis or pain$)).tw. 9. or/1-4,7-8 10. exp Adrenal Cortex Hormones/ 11. adrenal cortex hormone$.tw. 12. (steroid$ or corticosteroid$ or corticoid$ or glucocorticoid$ or sub-acromial or subacromial).tw. 13. (triamcinolone or methylprednisolone or hydrocortisone or predniso$ or cortisone or dexamethasone or betamethasone).tw.
14. or/10-13 15. exp Injections/ 16. inject$.tw. 17. 15 or 16 18. 14 and 17 19. 9 and 18
Appendix 2. EMBASE search strategy

1. Shoulder Pain/ 2. Shoulder Impingement Syndrome/ 3. Rotator Cuff/ 4. Bursitis/ 5. exp PAIN/ 6. Shoulder/ 7. 5 and 6 8. ((should$ or rotator cuff ) adj5 (bursitis or adhesive capsulitis or periarthriti$ or frozen or impinge$ or tend?nitis or pain$)).tw. 9. or/1-4,7-8 10. exp Corticosteroid/ 11. corticosteroid therapy/ 12. adrenal cortex hormone$.tw. 13. (steroid$ or corticosteroid$ or corticoid$ or glucocorticoid$ or sub-acromial or subacromial).tw. 14. (triamcinolone or methylprednisolone or hydrocortisone or predniso$ or cortisone or dexamethasone or betamethasone).tw. 15. or/10-13 16. exp Injection/ 17. inject$.tw. 18. 16 or 17 19. 15 and 18 20. 9 and 19 21. random$.ti,ab. 22. factorial$.ti,ab. 23. (crossover$ or cross over$ or cross-over$).ti,ab. 24. placebo$.ti,ab. 25. (doubl$ adj blind$).ti,ab. 26. (singl$ adj blind$).ti,ab. 27. assign$.ti,ab. 28. allocat$.ti,ab. 29. volunteer$.ti,ab. 30. crossover procedure.sh. 31. double blind procedure.sh. 32. randomized controlled trial.sh. 33. single blind procedure.sh. 34. or/21-33 35. exp animal/ or nonhuman/ or exp animal experiment/ 36. exp human/ 37. 35 and 36 38. 35 not 37 39. 34 not 38 40. 20 and 39
47
Appendix 3. CENTRAL search strategy

#1 #2 #3 #4 #5 #6 #7 #8 #9 #10 #11 #12 #13 #14 #15 #16 #17 #18 #19 (shoulder pain):ti MeSH descriptor Shoulder Pain explode all trees MeSH descriptor Shoulder Impingement Syndrome explode all trees MeSH descriptor Rotator Cuff explode all trees MeSH descriptor Bursitis explode all trees MeSH descriptor Pain explode all trees MeSH descriptor Shoulder Joint explode all trees (#5 AND #6) ((should* or rotator cuff ) near/5 (bursitis or adhesive capsulitis or periarthriti* or frozen or impinge* or tend*nitis or pain*)):ti,ab (#1 OR #2 OR #3 OR #4 OR #7 OR #8) MeSH descriptor Adrenal Cortex Hormones explode all trees adrenal next cortex next hormone*:ti,ab (steroid* or corticosteroid* or corticoid* or glucocorticoid* or sub-acromial or subacromial):ti,ab (triamcinolone or methylprednisolone or hydrocortisone or predniso* or cortisone or dexamethasone or betamethasone):ti,ab (#11 OR #12 OR #13 OR #14) MeSH descriptor Injections explode all trees inject*:ti,ab (#16 OR #17) (#10 AND #15 AND #18)
Appendix 4. CINAHL search strategy

CINAHL via Ovid (unil 2008) 1 Shoulder Pain/ 2 Shoulder Impingement Syndrome/ 3 Rotator Cuff/ 4 exp Bursitis/ 5 exp pain/ 6 exp Shoulder Joint/ 7 5 and 6 8 ((should$ or rotator cuff ) adj5 (bursitis or adhesive capsulitis or periarthriti$ or frozen or impinge$ or tend?nitis or pain$)).tw. 9 or/1-4,7-8 10 exp Adrenal Cortex Hormones/ 11 adrenal cortex hormone$.tw. 12 (steroid$ or corticosteroid$ or corticoid$ or glucocorticoid$ or sub-acromial or subacromial).tw. 13 (triamcinolone or methylprednisolone or hydrocortisone or predniso$ or cortisone or dexamethasone or betamethasone).tw. 14 or/10-13 15 exp Injections/ 16 inject$.tw. 17 15 or 16 18 14 and 17 19 9 and 18 CINAHL EBSCOHost (2008 to 2011) S22 S10 and S17 and S20 S21 S10 and S17 and S20 S20 S18 or S19 S19 ti inject* or ab inject* S18 (MH Injections+) S17 S11 or S12 or S13 or S14 or S15 or S16 S16 ab triamcinolone or ab methylprednisolone or ab hydrocortisone or ab predniso* or ab cortisone or ab dexamethasone or ab betamethasone
S15 ti triamcinolone or ti methylprednisolone or ti hydrocortisone or ti predniso* or ti cortisone or ti dexamethasone or ti betamethasone S14 ab steroid* or ab corticosteroid* or ab corticoid* or ab glucocorticoid* or ab sub-acromial or ab subacromial S13 ti steroid* or ti corticosteroid* or ti corticoid* or ti glucocorticoid* or ti sub-acromial or ti subacromial S12 ti adrenal cortex hormone* or ab adrenal cortex hormone* S11 (MH Adrenal Cortex Hormones+) S10 S1 or S2 or S3 or S4 or S7 or S8 or S9 S9 ab should* N5 bursitis or ab should* N5 adhesive capsulitis or ab should* N5 periarthriti* or ab should* N5 frozen or ab should* N5 impinge* or ab should* N5 tendinitis or ab should* N5 tendonitis or ab should* N5 pain* S8 ti should* N5 bursitis or ti should* N5 adhesive capsulitis or ti should* N5 periarthriti* or ti should* N5 frozen or ti should* N5 impinge* or ti should* N5 tendinitis or ti should* N5 tendonitis or ti should* N5 pain* S7 S5 and S6 S6 (MH Shoulder Joint+) S5 (MH Pain+) S4 (MH Bursitis+) S3 (MH Rotator Cuff+) S2 (MH Shoulder Impingement Syndrome) S1 (MH Shoulder Pain)
Appendix 5. ISI Web of Knowledge search strategy

ISI Web of Knowledge #1 Topic=(((should* or rotator cuff ) and (bursitis or adhesive capsulitis or periarthriti* or frozen or impinge* or tendonitis or tendinitis or pain*))) #2 Topic=(adrenal cortex hormone*) OR Topic=(steroid* or corticosteroid* or corticoid* or glucocorticoid* or sub-acromial or subacromial) OR Topic=(triamcinolone or methylprednisolone or hydrocortisone or predniso* or cortisone or dexamethasone or betamethasone) #3 Topic=(inject*) #4 #3 AND #2 AND #1
CONTRIBUTIONS OF AUTHORS
All authors contributed to the writing of the review.
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
49
Internal sources
Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Australia. In kind support Cabrini Institute, Cabrini Hospital, Malvern, Victoria, Australia. In kind support
External sources
No sources of support supplied
DIFFERENCES BETWEEN PROTOCOL AND REVIEW

We have claried that included trials could include comparators of anatomic landmark guided injection or intramuscular injection. We planned a sub-group analysis based on three time points ( 6 weeks; >6 weeks to 6 months; > 6 months), but included studies only measured outcomes to 6 weeks. For the purpose of pooling data we combined 1-2 weeks in one analysis and 6 weeks in another analysis. We also planned to perform sensitivity analysis to investigate the effect of imputation of missing data (e.g., imputation of standard deviation) if data were available but this was not performed.
INDEX TERMS Medical Subject Headings (MeSH)

Landmarks; Anti-Inammatory Agents [administration & dosage]; Betamethasone [administration & dosage]; Glucocorticoids [ administration & dosage]; Injections [methods]; Randomized Controlled Trials as Topic; Shoulder Pain [ drug therapy]; Triamcinolone [administration & dosage]; Ultrasonography, Interventional [ methods]
Anatomic
MeSH check words

Female; Humans; Male
50

Cochrane - Image-Guided Versus Blind Glucocorticoid Injection For Shoulder Pain (Review) PDF

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Cochrane - Image-Guided Versus Blind Glucocorticoid Injection For Shoulder Pain (Review) PDF

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Image-guided versus blind glucocorticoid injection for shoulder pain (Review)

Bloom JE, Rischin A, Johnston RV, Buchbinder R

Image-guided versus blind glucocorticoid injection for shoulder pain

rst author. b Joint rst author

Ultrasound-guided injection compared to landmark or intramuscular injection for shoulder pain

Serious adverse events See comment - not reported

Description of the intervention

How the intervention might work

Why it is important to do this review

with shoulder disorders is not yet established.

Criteria for considering studies for this review

Search methods for identication of studies

The primary efcacy outcomes were:

Data collection and analysis

Figure 1. Study ow diagram.

Risk of bias in included studies

Efcacy of ultrasound-guided injection versus landmark or intramuscular injection

Overall Pain (includes daytime, activity-related and unspecied pain)

patients with either image- or landmark-guided or intramuscular injection.

Overall completeness and applicability of evidence

Summary of main results

Quality of the evidence

Potential biases in the review process

Agreements and disagreements with other studies or reviews

AUTHORS CONCLUSIONS Implications for practice

Implications for research

References to studies included in this review

References to studies excluded from this review

References to studies awaiting assessment

Characteristics of included studies [ordered by study ID]

Sources of funding Notes

Random sequence generation (selection Unclear risk bias)

Allocation concealment (selection bias)

Selective reporting (reporting bias)

Random sequence generation (selection Low risk bias)

Allocation concealment (selection bias)

Selective reporting (reporting bias)

Sources of funding Notes

Random sequence generation (selection High risk bias)

Allocation concealment (selection bias)

Blinding of outcome assessment (detection Low risk bias) All outcomes

Incomplete outcome data (attrition bias) All outcomes

Selective reporting (reporting bias)

Sources of funding Notes

Blinding of outcome assessment (detection Low risk bias) All outcomes

Incomplete outcome data (attrition bias) All outcomes

Selective reporting (reporting bias)

No evidence of any other bias.

Random sequence generation (selection Unclear risk bias)

Incomplete outcome data (attrition bias) All outcomes

Selective reporting (reporting bias)

Characteristics of excluded studies [ordered by study ID]

Sibbitt 2009 Tveita 2008 Valtonen 1978

Widiastuti-Samekto 2004 Yi 2006

Characteristics of studies awaiting assessment [ordered by study ID]

DATA AND ANALYSES

Comparison 1. Ultrasound-guided injection versus landmark or systemic injection

Statistical method Std. Mean Difference (IV, Random, 95% CI)

146 207 146 207

186 166 312 146 166 207

Comparison 2. Sensitivity analysis (adequate treatment allocation concealment, and blinding)

Landmark or systemic N Mean(SD)

Std. Mean Difference IV,Random,95% CI