Author’s Accepted Manuscript

A Systematic Review and Meta-Analysis of the

Efficacy of Manipulative Therapy in Women with
Primary DysmenorrheaEffect of Manipulative
Therapy on Primary Dysmenorrhea

Ukachukwu Okoroafor Abaraogu, Sylvester Emeka

Igwe, Chidinma Samantha Tabansi-Ochiogu,
Deborah Onyinyechukwu Duru www.elsevier.com/locate/jsch

PII: S1550-8307(17)30022-8
DOI: http://dx.doi.org/10.1016/j.explore.2017.08.001
Reference: JSCH2230
To appear in: Explore: The Journal of Science and Healing
Cite this article as: Ukachukwu Okoroafor Abaraogu, Sylvester Emeka Igwe,
Chidinma Samantha Tabansi-Ochiogu and Deborah Onyinyechukwu Duru, A
Systematic Review and Meta-Analysis of the Efficacy of Manipulative Therapy
in Women with Primary DysmenorrheaEffect of Manipulative Therapy on
Primary Dysmenorrhea, Explore: The Journal of Science and Healing,
http://dx.doi.org/10.1016/j.explore.2017.08.001
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Title:A Systematic Review and Meta-Analysis of the Efficacy of Manipulative Therapy in

Women with Primary Dysmenorrhea

Short title:Effect of Manupulative Therapy on Primary Dysmenorrhea.

Authors:1,3*Ukachukwu Okoroafor ABARAOGU, 1Sylvester Emeka IGWE, 2Chidinma

Samantha TABANSI-OCHIOGU, 1Deborah Onyinyechukwu DURU.

Authors Affiliations:1Department of Medical Rehabilitation Faculty of Health Science and

Technology College Medicine University of Nigeria.2Physiotherapy Department University of
Calabar Teaching Hospital, Calabar Nigeria.3School of Health and Life Sciences Glasgow
Caledonian University United Kingdom

Correspondence: *Abaraogu Ukachukwu Okoroafor │Department of Medical Rehabilitation

Faculty of Health Science and Technology College Medicine University of Nigeria Enugu
Campus 400006 Enugu NigeriaEmail: ukachukwu.abaraogu@unn.edu.ng

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Title: Manipulative Therapy for Women with Primary Dysmenorrhea: A Systematic Review and
meta-analysis.

Short title: Effect of Manipulative Therapy on Primary Dysmenorrhea.

ABSTRACT

Objective: To assess the robustness of evidence for the efficacy of manipulative therapy in

women with primary dysmenorrhea.

Method: Seven electronic databases were searched for studies reporting data on manipulative

therapy for women with primary dysmenorrhea. The primary and secondary outcomes were pain

relief and quality of life respectively. Quality of eligible studies was assessed using the

Physiotherapy Evidence Database (PEDro) guideline.

Results: The search yielded 19 citations of which four were systematically reviewed and three

eligible for meta-analysis. The systematic review showed above moderate methodological

quality with a mean of 6.7 out of 10 on the PEDro quality scale. Manipulative therapy showed

evidence of pain reduction in primary dysmenorrhea.

Conclusion: Manipulative therapy could be considered as adjunct therapy in the relief of pain in

primary dysmenorrhea. More high quality research is needed before the evidence for their

utilization can be ascertained. Particularly, items related to assessor blinding should be

considered in future studies.

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Keywords: Manual therapy, Manipulative therapy, Spinal manipulation, Global pelvic

manipulation.

BACKGROUND

Primary dysmenorrhea is defined as painful menses in women with a normal pelvic anatomy [1].

The pain is believed to be due to uterine hypoxia and ischaemia from excessive production and

release of prostaglandins during menstruation by the endometrium which in turn causes hyper-

contractility of the uterus [1]. Menstrual pain constitutes a significant health, social and

economic burden, and is related to absenteeism from school or work in about one third to half of

women of reproductive age [2], with about 5-14% absenteeism frequently occurring [2].

Increased severity of dysmenorrhea significantly reduces health related quality of life [3] in this

population. Drug management for primary dysmenorrhea is focused on alleviating menstrual

pain and relaxing the uterine muscles using non-steroidal anti-inflammatory drugs (NSAIDs) or

oral contraceptives

[4]. However, numerous side effects including nausea, breast tenderness, intermenstrual

bleeding, and hearing and visual disturbances have been reported with the use of NSAIDs[5] and

oral contraceptives[6-8]. In addition, menstrual pain is not adequately controlled by NSAIDs in

about a quarter of women with primary dysmenorrhea [9]. Therefore, research into effective

alternative non-pharmacological modalities for relieving pain and improving quality of life in

women with primary dysmenorrhea is needed. Many alternative interventions [10-13], including

manipulative therapies [14-15] have been suggested as a non-medical intervention for the relief

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of symptoms of dysmenorrhea. Nonetheless, there is conflicting evidence regarding the benefit

of different manipulative therapy interventions.

To refine the available evidence Proctor et al conducted a systematic review of manipulative

therapy interventions for dysmenorrhea and concluded that there is no evidence to suggest that

spinal manipulation is effective in treatment of dysmenorrhea [16]. However, there were some

important limitations that need to be addressed. First, owing to their review objectives,

participants in this study who had dysmenorrhea of identifiable pathology (secondary

dysmenorrhea) were included in the review. The inclusion of participants with secondary

dysmenorrhea potentially contaminates the overall findings with implication that the conclusion

specific to the effect of manipulative therapy on primary dysmenorrhea may not be drawn from

the review findings. Further, they did not investigate outcomes of quality of life. Given that

primary dysmenorrhea significantly impact on the quality of life of women, reviewing evidence

for the effect of a potentially effective alternative adjunct intervention as manipulative therapy,

on quality of life, will be of clinical value. The objective of this study was therefore to

systematically review available evidence for the effect of manipulative therapy in pain relief and

quality of life improvement in women with primary dysmenorrhea.

METHODS

Study Design: This was a systematic review with meta-analysis of randomized controlled trials

(RCT) on manipulative therapy in primary dysmenorrhea.

Data Sources: A comprehensive search strategy was conducted online in order to identify all

relevant publications on manipulative therapy interventions for the relief of pain and quality of

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life improvement in females with primary dysmenorrhea. Allied health, and medical databases

including Ovid Medline, PubMed, PEDro, CINAHL, PsyclINFO, AMED and EMBASE was

searched. The search was performed using the following key indexing terms independently:

manipulative therapy, spinal manipulation, physiotherapy, physical therapy, pelvic manipulation,

primary dysmenorrhea, quality of life, physical intervention. Google search and a manual search

of the reference lists of existing articles was also conducted to find papers that were not included

in the main databases. The search covered literature from 1970 to July 2016.

STUDIES SELETION CRITERIA

Decisions on the inclusion and exclusion criteria related to the review were adapted from

previous systematic reviews on dysmenorrhea [16-17], and tailored to the primary aim of the

present systematic review. Importantly all selection criteria were specific to primary

dysmenorrhea. RCTs with the main focus on the efficacy, effectiveness, or effect of different

manipulative therapies on primary dysmenorrhea were included. Only studies utilizing human

female subjects in their reproductive age were eligible. Trials were limited to those published in

English language peer-reviewed journals and conference proceedings. A study has to have had

participants affected by moderate to severe primary dysmenorrhea (pain affecting daily activity

or with a high baseline score ≥3 on visual analogue pain (VAS) or an equivalent tool).

Participants in eligible study must have had primary dysmenorrhea in the majority (> 50%) of

menstrual cycles, in addition to primary dysmenorrhea for at least one day of menses. Studies

were excluded if participants had irregular or infrequent menstrual cycles (usually outside of the

typical range of a 21 to 35 day cycle); were using an intra-uterine contraceptive device (IUD), or

oral contraceptive pills (OCP).

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All studies meeting these broad criteria were initially included. In any case that decision could

not be made based on the title and abstract of the paper. The authors were contacted for any

missing data and the full text of the paper was included for further decision. Subsequent

inclusion, based on the inclusion criteria, was then assessed independently by the two review

authors. When a difference of opinion occurred, consensus was reached by discussion and

reflection, in consultation with a third review author.

Data Collection and Management

Two authors independently performed data collection from the included studies.

Standardization of the procedure was required for consistency. To this effect, data collection was

performed with a pre-designed form (see below) and prior to the initiation of data collection, a

trial was conducted on two similar but unrelated papers and the result was discussed. A third

author was consulted when there were disagreements regarding data collection. The opinion of

the third author stimulated further discussion to arrive at a consensus. This data extraction

method (double data extraction) has been shown to have a lower rate of error than simple data

extraction [18]. Pooling of data was undertaken where adequate homogeneity of results existed.

For each included RCT, data were extracted regarding the participants (age range, eligibility

criteria), the nature of the interventions, and the outcomes.

Data Extraction Form: This form consists of descriptive characteristics (see table 1) and a

quality appraisal tool. Data was extracted based on the elements of this form which are related to

the research questions and aims of this systematic review.

QUALITY APPRAISAL: The quality of each paper was assessed using the Physiotherapy

Evidence Database (PEDro) quality appraisal tool [19]. Answers to the quality appraisal items

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were defined as Yes, No, Not applicable or Unclear. A score of one was given to each yes

answer and zero to no, unclear and not applicable (N/A) answers. The overall score was reported

as a tally/total of all yes answers out of 10 based on the applicable answers for each study.

Scores of individual items from the critical appraisal tool were added to present a total score.

RESULTS

Flow of studies through the review

Initial search yielded a total 19 studies. Four studies were removed as duplicates; three,

because they were not peer reviewed, and further three after title and after screening. Therefore a

total of nine studies were eligible for full length reading. Exclusion of five more studies was

undertaken based on reasons ranging from studies not reported in English language (n=1), pain

relief outcome measure not convertible to 0-10 VAS scale (n=1), study not reporting either of

pain relief or quality of life outcomes (n=1), inclusion of participants with other complications

(eg dsyperunia, chronic low back pain) (n=1), and being a case reports (n=1). Finally four met

the inclusion criteria for the systematic review and three the criteria for meta-analysis. The flow

of papers through the process of assessment of eligibility is represented in figure 1 with reasons

for exclusion of papers at each stage of the process. Study authors were contacted up-to a

maximum of three times when data were not reported in the format that allowed inclusion in the

review. Where data could not be included in a suitable format, the paper was excluded.

Characteristics of included trials

Four trials contributing data on 285 participants were included in the systematic review. Three of

them, contributing data on 217 participants, met the criteria for inclusion in the meta-analysis.

The sample sizes contributed by the included trials ranged from 39 to 138. The mean age of

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participants in the included trials ranged from 18 to 49 years. The included studies consist of

trials published from 1985 to 2014.

Quality of included trial

The physiotherapy evidence database (PEDro) quality appraisal tool was used to assess the

sources of bias and to rate the methodological quality of included trials. The methodological

quality of the included trials ranged from moderate to high with a mean PEDro score of 6.7 out

of 10. Two trials were methodologically high-quality trials with scores of 8. The individual

PEDro items satisfied by all the trials were random allocation, groups similar at baseline, and

reporting of between group differences. The quality appraisal of the included trials is presented

in Table 1 while the characteristics of included trials and outcomes reported for each outcome is

presented in Table 2.

Insert figure 1 about here

Level/grade of evidence

The completeness of outcome data for each outcome was adequately described in all the included

studies in the meta-analysis. No other limitations, such as stopping early for benefit or use of

invalidated outcome measures, were identified in any of the included studies. The summary of

findings and evidence profile are presented in Tables 1 and 2. The overall grade of the evidence

obtained for the outcome of manipulative intervention trials was ‘moderate’.

Interventions

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One trial [20] compared the effect of spinal manipulative therapy to low force mimic

manoeuvre. One trial [21] compared the effect of spinal manipulative therapy to a sham

procedure. One trial [22] compared the effect of bilateral global pelvic manipulation (GPM) to a

sham procedure while one trial [23] compared reflexology and ibuprofen groups.

Outcome measures: All the included trials measured pain intensity/severity as outcome measure

with all the four trials using VAS. In addition, one trial used pain rating index and two trials used

the menstrual distress questionnaire. Two trials also assessed the plasma concentration of the

prostaglandin F2α metabolite (KDPGF2α)

Excluded studies: Out of the four studies included in the systematic review, one [24] was

excluded from the meta-analysis because it did not meet the inclusion criteria for meta-analysis,

which was trial with control/placebo/sham groups.

Inset Table 1 and Table 2 about here

Insert Figure 2 about here

Manipulation versus sham procedure

The forest plot (figure 2) showed a meta-analysis of outcomes related to pain intensity

following manipulative therapy interventions versus placebo. Meta-analysis of the trials showed

a significant effect in decreasing overall pain scores in the manipulative therapy group (See

figures A) compared to the sham (See figures B), demonstrating a high effect size (-0.939; CI

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0.6579-1.218). This suggests that the procedure may be an effective non-pharmacological

alternative for relieving the pain of primary dysmenorrhea.

DISCUSSION

Meta-analysis of the three trials [20-22] of spinal manipulative therapy showed a significant

effect on reducing pain in women with primary dysmenorrhea even when, on the individual

level, one trial [20] recorded no treatment effect after spinal manipulation with low-force mimic

manoeuvre as the sham procedure. Interestingly, two trials [20-21] both applied similar

techniques in treatment group with different sham procedures as control. Kokjohn et al [21]

indicated an association of placebo effect with a single sham intervention and advised

involvement of more subjects to resolve the question of a placebo effect. The third trial [22], a

more recent one, indicated a short term improvement in pain with a different form of global

spinal manipulation. As the interventions applied in two of the trials were similar but had

differing effects; and a positive effect was seen in not so similar manipulation, it is difficult to

differentiate positive effects from mere random variations.

Two previous reviews on manipulative therapy interventions for individuals with dysmenorrhea

have been conducted [16; 24]. Ernst et al. [24] was a review of reviews of manipulative therapy

interventions in several clinical indications including dysmenorrhea, and concluded that spinal

manipulation was an ineffective intervention for dysmenorrhea. Similarly, Molins-Cubero et al

[16] concluded that there is no evidence to suggest manipulative therapy interventions is

effective in the relief of pain in women with dysmenorrhea. In contrast, though with a small

number of trials, the meta-analysis from our current review clearly demonstrates that

manipulative therapy is effective in pain relief compared to sham manoeuvres in women with

primary dysmenorrhea.

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How can the contrasting finding between the present review and the two previous ones be

explained? Both previous reviews were not designed to synthesize evidence for manipulative

therapy specific to primary dysmenorrhea. Accordingly, participants’ inclusion criteria permitted

inclusion of studies of participants with secondary dysmenorrhea. This may have warranted

drawing conclusion with evidence derived from heterogeneous patient disease characteristics.

Given that varied therapeutic outcomes have been documented in the pharmacological

management for dysmenorrhea as a result of underlying pathology, perhaps the effect of

manipulative therapy intervention may have been masked by identifiable disease pathologies in

the participants included in those two previous reviews leading to an overall conclusion of no

effect of interventions.

Our present systematic review has several limitations. First, the studies satisfying the inclusion

criteria were clinically and methodologically heterogeneous with respect to the severity of pain,

participants, the different types and techniques of intervention used in similar trials. Secondly,

the follow-up length and timing of outcome assessment also varied, as did the treatment schedule

and frequency. In addition, this review did not clearly exclude possible publication bias. Despite

the limitations of the present review, three homogenous trials in terms of design, comparators

and outcomes were pooled into a random effect meta-analysis providing a conclusion of high

scientific value.

In conclusion, the systematic review highlighted promising evidence for the effectiveness of

manipulative therapy in relief of pain for women with primary dysmenorrhea. However, the

results were limited with methodological flaws. Further research is recommended with improved

trial design quality, intervention fidelity and degree of reporting of clinical trials. Future

researchers should follow the basic guidelines for reporting clinical trials. Further researches

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should also be conducted with patient blind and assessor blind against a sham control

intervention in order to allow for placebo effect. They should also be of sufficient sample size

and employ validated outcome measures of clinical effectiveness. Quality of life of participants

should also be included as outcome of interest in future researches.

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for dysmenorrhea. Cochrane Database of systematic reviews 2015, Issue 7. Art. No.:

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acupressure for relief of primary dysmenorrhea symptoms: a systematic review with

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and quality of life of patients with primary dysmenorrhea: a systematic review with meta-

analysis. Turk J Phys Med Rehab 2016;62(4):346-354.

14. King HH. Manual Therapy may benefit women with primary dysmenorrhea. J Am

Osteopathic Assoc 2013; 113(4): 359-360.

15. Molins-Cubero S, Boscá-Gandía JJ, Rus-Martínez MA. Assessment of low back and

pelvic pain after applying the pelvis global manipulation technique in patients with

primary dysmenorrhea: a pilot study. Eur J Ost Clin Rel Res. 2012;7(1):29-38.

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16. Proctor M, Hing W, Johnson TC, Murphy PA, Brown J. Spinal manipulation for

dysmenorrhea. Cochrane Database of Systematic Reviews 2006, Issue 3. Art. No.:

CD002119. DOI: 10.1002/14651858.CD002119.pub3.

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2010; CD004142. DOI: 10.1002/14651858.CD004142.

18. Buscemi N, Hartling L.B, Vandermeer L, Tjosvold, and Klassen P (2006). Single data

extraction generated more errors than double data extraction in systematic reviews. J Clin

Epi 59: 697-703.

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2006;94(4):477-478.

20. Hondras MA, Long CR, Brennan PC. Spinal manipulative therapy versus a low force

mimic manoeuver for women with primary dysmenorrhea: a randomized, observer-

blinded, clinical trial. Pain 1999; 81(1-2):105-14

21. Kokjohn K, Schmid DM, Triano JJ and Brennan PC. Effect of spinal manipulation on

pain and prostaglandin levels in women with primary dysmenorrhea. J Manipulative

Physiol Ther. 1992 Jun;15(5):279-285.

22. Molins-Cubero S., Rodríguez-Blanco C., Oliva-Pascual-Vaca A., Heredia-Rizo A. M.,

Boscá-Gandía J. J., and Ricard F. Changes in Pain Perception after Pelvis Manipulation

in Women with Primary Dysmenorrhea: A Randomized Controlled Trial. J Pain Med

2014; 1599:1455-1463.

23. Valiani M, Babaei E, Heshmat R, and Zare Z. Comparing the effects of reflexology

methods and Ibuprofen administration on dysmenorrhea in female students of Isfahan

University of Medical Sciences. Iran J Nurs Midwifery Res 2010; 15: 371-378.

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24. Ernst E and Canter PH. A Systematic Review of Systematic Reviews of Spinal

Manipulation. J Royal Society Med 2008; 99: 189–193.

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Papers retrieved by search (n=19)

Not from a peer reviewed journal (n=3)

Duplicates (n=4)

Excluded after screening title and abstract

(n=3)

 Ineligible intervention (n=2)

 Studies on systematic reviews (n=1)

Papers screened by evaluation of full

text (n=9)

Excluded after screening full text (n=5)

 Wrong language and translation (n=1)

 Outcome measure of pain intensity not convertible to 0-10
scale(n=1)
 No pain intensity/quality of life outcome measure(n=1)
 Included participants with other complications eg
dsyperunia, chronic low back pain (n=1)
 Case reports and expert opinion(n=1)

Studies included for systematic

review (n=4)

Excluded after first review (n=1)

 Compared non-manipulative therapy interventions and no
distinct control groups or placebo (n=1)

Studies included for meta-

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analysis (n=3)

Figure 1: Flow of studies through the review

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Figure 2: Forest plot of weighted mean difference (95% CI) for pain intensity for manipulation

versus sham procedure. Key: A=Manipulative interventions; B=Sham interventions

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Table 1; PEDro quality appraisal of studies on manipulation

Study Rando Conceal Group Participa Therapi Assess <15 Intenti Between Paint Tot
Name m ed s nt st or % on to Group Estimate al 0-
of Allocati Allocati Simila Blinding Blindin Blindi Dro Treat Differen & 10
Autho on on r at g ng p Analysi ce Variabili
r Baseli out s ty
ne Reporte
d
1) Y N Y N Y Y Y Y Y Y 8
Hondr
as et
al.
1999
2) Y N Y Y N Y Y N Y N 6
Kokjo
hn et
al.
1992
3) Y N Y Y N Y Y N Y Y 8
Molins
-
cubero
et al.
2014
(4) Y N Y N N N N Y Y Y 5
Valian
i
et al.
2010

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TABLE 2: DESCRIPTIVE CHARACTERISTICS OF STUDIES ON MANIPULATION

STUDY DESIGN PARTICIPANTS INTERVENTION CONTROL OUTCOME

MEASURES

1) Hondras et RCT n = 138 (Intervention = Spinal Manipulative Low force VAS (0-10)
al. 1999 69, cm = 69) therapy mimic
maneuver MDQ%
Age = con = 29.7 (18-
45) KDPGF2 α (pg/ml) for
prostaglandin levels
VAS = ?
(Plasma cone of the
MDQ = prostaglandin F2 α
metabolite
KDPGF =
2) Kokjohn et RCT n =39 (Exp = 20, cm = Spinal manipulative Sham Pain (abdominal &
al. 1992 19) therapy procedure back pain) VAS (0-
10cm)
Age = 20-49 (30.3)
Menstrual distress:
KDPGF = (Exp = MDQ
133.88, cm = 142.82)
Prostaglandin/Plasma
MDQ = (Exp 44.22, levels of KDPGF2α
cm=47.86)
VAS: Abdominal pain:
Exp = 5.87, cm=6.0
Back pain: Exp = 4.83,
cm = 5.21
3) Molins- RCT n = 40 (Exp = 20, cm = Bilateral Global Pelvic Sham - Pain perception,
Cubero et al. 20) Manipulation procedure VAS (0-100)mm
2014 technique
age = 30+ 6.10yrs (19- - Serotonin &
48) yrs catecholamine levels
analyzed in plasma
VAS = >5 by high performance
liquid
PPT (height) = Exp = chromatography
1.58 + 0.65
- Pressure pain
PPT (left) = cm = 1.40 + threshold
0.45
4) Valiani et al. RCT n =68 (Reflexology Group I -> reflexology No control Seventy of
2010 group -> 32, Ibuprofen (20 daily sessions, 40 group dysmenorrhea; VAS
minutes) (0-10)cm
group -> 36)
Age = 21.6 + 1.79yrs Group II -> Ibuprofen PR I (0-42)
VAS; Ref. group -> 4.24 (400mg) once every
Ibuprofen group -> 4.31 8hrs 43 days during 3 Duration of
PRI, Ref: 33.96 consecutive menses menstrual pain (hrs)
Ibu; 34.19 cycle
Key: RCT= randomized control trial; VAS= visual analogue scale; MDQ= Menstrual Distress Questionnaire.

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