Abstracto

Antecedentes Una regla de prediccin clnica (CPR) pretenda identificar a los pacientes con dolor de cuello que son propensos a responder a la columna vertebral de empuje manipulacin torcica se ha desarrollado recientemente pero a!n no se ha validado" Objetivo #l objetivo de este estudio fue e$aminar la valide% de este CPR" Disear #ste fue un estudio multic&ntrico aleatori%ado ensa'o clnico" Mtodos Ciento cuarenta pacientes con un informe principal de dolor en el cuello fueron asignados al a%ar para recibir 'a sea ( sesiones de estiramiento ' ejercicios de fortalecimiento (de slo ejercicio de grupo) o ) sesiones de manipulacin de la columna torcica ' cervical gama de ejercicios de movimiento seguido de * sesiones de estiramiento ' ejercicios de fortalecimiento (manipulacin + ejercicio de grupo)" ,e recogieron datos sobre la discapacidad ' el dolor al inicio del estudio - semana . semanas ' / meses" #l objetivo primario (grupo de tratamiento 0 tiempo 0 estatus en la regla de prediccin) se e$amin utili%ando un modelo mi$to lineal con medidas repetidas" #l tiempo el grupo de tratamiento ' la situacin en el #stado as como todas las posibles de ) ' * vas interacciones se modelaron como efectos fijos con discapacidad (' el dolor) como la variable dependiente" ,e calcularon los tama1os del efecto para el dolor ' la discapacidad en cada perodo de seguimiento" Resultados 2o hubo interaccin de * vas 'a sea para la discapacidad o dolor" 3 ) vas (grupo 0 tiempo) la interaccin e$istente tanto para la discapacidad ' el dolor" Comparaciones por pares de discapacidad demostraron que e$istan diferencias significativas en cada perodo de seguimiento entre la manipulacin + grupo de ejercicio ' el !nico ejercicio en grupo" 4os pacientes que recibieron la manipulacin mostraron puntuaciones de dolor ms bajas en el perodo de seguimiento de - semana" 4os tama1os del efecto fueron moderados por la discapacidad en cada perodo de seguimiento ' fueron moderados por el dolor en el -5 semanas de seguimiento" Limitaciones 6iferentes enfoques de ejercicio pueden haber dado lugar a un resultado diferente" Conclusiones 4os resultados de este estudio no apo'an la valide% de la RCP desarrollado previamente" ,in embargo los resultados demostraron que los pacientes con cervicalgia mecnica que recibieron la manipulacin de la columna torcica ' el ejercicio mostraron mejoras significativamente ma'ores en la discapacidad tanto en el perodo de seguimiento a corto ' largo pla%o ' en el dolor en el -5semanas de seguimiento en comparacin con los pacientes que recibieron slo ejercicio" More than 50% of individuals typically will experience neck pain - at some point in their life, and the incidence of neck pain appears to be increasing. ) The economic burden associated with the treatment of patients with neck pain is high, second only to low back pain !"#$ in annual workers% compensation costs in the &nited 'tates.* #atients with neck pain fre(uently are encountered in outpatient physical therapist practice. . )ecent evidence has begun to support the effectiveness of many interventions used by physical therapists for the management of neck pain. (7-*ne intervention often used by physical therapists in the management of neck pain is thoracic spine manipulation. "ased on low+(uality evidence, a recent ,ochrane review suggested that thoracic spine manipulation may be beneficial for reducing pain and improving function in patients with neck pain.-) - recently published guideline for the management of patients with neck pain has recommended the use of thoracic spine thrust manipulation in the management of this population.-* .inally, a recent meta+analysis reported that thoracic spine manipulation has been shown to be effective in reducing pain and improving function in subgroups of patients, but the included studies examined only short+term outcomes. -. )ecently, a derivation study was conducted with a primary goal of developing a clinical prediction rule ,#)$-( to identify the subgroup of patients with neck pain likely to benefit from thoracic spine thrust manipulation. /n this derivation study, the researchers treated all patients with thoracic manipulation and a general range of motion )*M$ exercise and identified characteristics of patients who improved most while receiving treatment. These characteristics were used to define a preliminary prediction rule for identifying patients with neck pain most likely to benefit from thoracic spine thrust manipulation. - shortcoming of a derivation study with a single treatment arm is the inability to determine whether the subgroup identified in the study includes patients who will preferentially benefit from the treatment provided or patients who have a favorable prognosis regardless of treatment.-/ - controlled trial, therefore, is re(uired to evaluate whether the subgroup identified by the ,#) derived in the previous single+arm study included patients who preferentially

benefited from thoracic manipulation or simply those with a favorable prognosis regardless of treatment.-8 -9 The purpose of this randomi0ed clinical trial was to examine the validity of the previously derived ,#). Previous ,ection2e$t ,ection

Method
Patients :ith a primar' report of nec; pain seen in - of ( ph'sical therap' clinics across the United ,tates (Concord <ospital Concord 2e: <ampshire= >ellin <ealth ?reen >a' @isconsin= Universit' of Colorado 3urora Colorado= @ardenburg <ealth Center at the Universit' of Colorado at >oulder >oulder Colorado= and 2e:ton5@ellesle' <ospital 2e:ton Aassachusetts) bet:een Bul' )CC8 and 6ecember )CC9 :ere screened for eligibilit'" Dhe e$act inclusion and e$clusion criteria from the derivation stud' -( :ere used to determine participant eligibilit' for this trial" Eor patients to be eligible to participate the' had to have a primar' report of nec; pain :ith or :ithout unilateral upper5e$tremit' s'mptoms be bet:een -9 and /C 'ears of age and have a 2ec; 6isabilit' Fnde$ (26F) score of at least )CG" #$clusion criteria included serious pathologies diagnosis of cervical spinal stenosis (as identified in the patientsH medical inta;e form) or bilateral upper5e$tremit' s'mptoms evidence of central nervous s'stem involvement ) or more positive neurologic signs consistent :ith nerve root compression pending legal action regarding their nec; pain or inabilit' to adhere to the treatment and follo:5up schedule" 3ll patients provided informed consent prior to their enrollment in the stud'" Examination Procedures Prior to randomi%ation patients under:ent a standardi%ed histor' and ph'sical e$amination that :ere identical to those of the derivation stud'" -( 6emographic information collected included age se$ mechanism of injur' location and nature of the patientHs s'mptoms and the number of da's since onset of s'mptoms" ,pecific details regarding the ph'sical e$amination are published else:here -( and included measures of muscle length and strength (force5generating capacit') RIA and vertebral mobilit' and a thorough screening e$amination designed to identif' an' contraindications to thoracic spine manipulation (h'perrefle$ia unsteadiness during :al;ing n'stagmus loss of visual acuit' impaired sensation of the face altered taste the presence of pathological refle$es)" -(3dditionall' an' serious pathologies or conditions (tumor fracture metabolic diseases rheumatoid arthritis osteoporosis histor' of prolonged steroid use) identified on the patientHs medical screening questionnaire :ere considered contraindications to treatment" 3ll patients completed several commonl' used instruments to assess pain and function" Dhe 26F is the most :idel' used condition5specific disabilit' scale for patients :ith nec; pain and consists of -C items addressing different aspects of function each scored from C to ( :ith a ma$imum score of (C points" -J )C Dhe score then is doubled and interpreted as a percentage of the patient5perceived disabilit'" <igher scores represent increased levels of disabilit'" Dhe 26F has been reported to be a reliable and valid outcome measure for patients :ith nec; pain"-J )-7)* 3n --5point numeric pain rating scale (2PR,) :as used to measure pain intensit'" Dhe scale is anchored on the left (score of C) :ith the phrase Kno painL and on the right (score of -C) :ith the phrase K:orst imaginable pain"L 2umeric pain rating scales have been sho:n to 'ield reliable and valid data" ).7)J Patients rated their current level of pain as :ell as their :orst and least amount of pain in the previous ). hours" Dhe average of the * ratings :as used to represent the patientHs level of pain" Dhe Eear53voidance >eliefs Muestionnaire (E3>M) is a -/5item questionnaire designed to quantif' fear and avoidance beliefs in patients :ith 4>P" *C Dhe E3>M has ) subscalesN a 85item scale to measure fear5 avoidance beliefs about :or; (E3>M@) and a .5item scale to measure fear5avoidance beliefs about ph'sical activit' (E3>MP3)" #ach item is scored from C to / :ith possible scores ranging from C to ). for the E3>MP3 and from C to .) for the E3>M@ and :ith higher scores representing increased fear5avoidance beliefs" Eor this stud' the E3>M :as modified b' replacing the :ord Kbac;L :ith the :ord Knec;"L >oth the E3>MP3 and E3>M@ also modified in this :a' :ere originall' identified in the derivation stud' as potential predictors associated :ith a positive response to thoracic spine thrust manipulation in a patient population :ith nec; pain"-( 3dditionall' at each follo:5up period patients completed the -(5point ?lobal Rating of Change (?RIC) described b' Baesch;e et al"*- Dhe scale ranges from O8 (Ka ver' great deal :orseL) to C (Kabout the sameL) to +8 (Ka ver' great deal betterL)" Ft has been reported that scores of +. and +( are indicative of moderate changes in patient5perceived status and that scores of +/ and +8 indicate large changes in patient

status"*- ,imilar to the stud' that originall' derived the CPR -(patients :ho rated their perceived recover' on the ?RIC as Ka ver' great deal better L Ka great deal better L or Kquite a bit betterL (ie a score of +( or greater) at an' of the follo:5up periods :ere categori%ed as a success" Randomization Ince the e$amination :as complete patients :ere randoml' assigned to - of ) groupsN (-) patients :ho received thoracic spine manipulation and an e$ercise program (manipulation + e$ercise group) or ()) patients :ho received a stretching and strengthening e$ercise program (e$ercise5onl' group)" Concealed allocation :as performed b' an individual not involved in data collection using a computer5generated randomi%ed table of numbers created for each participating site prior to the beginning of the stud'" Fndividual sequentiall' numbered inde$ cards :ith the random assignment :ere prepared" Dhe inde$ cards :ere folded and placed in sealed opaque envelopes" Treating Therapists Den ph'sical therapists :ith a mean of 9"8 'ears (,6P/"J rangeP-7)-) of clinical e$perience participated in the recruitment e$amination and treatment of all patients in this stud'" 3ll therapists under:ent a standardi%ed training regimen :hich included stud'ing a manual of standard procedures :ith the operational definitions of each e$amination and treatment procedure" Participating therapists under:ent a *5hour training session provided b' one of the investigators" 6ue to the nature of the interventions used in this stud' therapists could not be blinded" <o:ever individuals :ho collected all outcome measures :ere blinded to group assignment" >oth treating clinicians and outcome assessors :ere una:are of patientsH status on the CPR" Treatment Procedures Patients in both groups attended ph'sical therap' sessions t:ice :ee;l' during the first :ee; and then once :ee;l' for the ne$t * :ee;s for a total of ( sessions over a .5:ee; period" Exercise-only group. Dhis group :as treated :ith a stretching and strengthening program" Recent guidelines and revie:s have supported the use of e$ercise to decrease pain improve function and reduce disabilit' in a patient population :ith nec; pain"*) ** 3t each session the ph'sical therapist manuall' stretched the patientHs upper trape%ius scalene sternocleidomastoid levator scapulae and pectoralis major and minor muscles" #ach stretch :as held for *C seconds and repeated t:ice" ,trengthening e$ercises included deep nec; fle$or training cervical isometrics and middle and lo:er trape%ius and serratus anterior muscle e$ercises" #ach e$ercise :as performed for -C repetitions :ith a goal of a -C5second hold" 3 detailed description of the strengthening and fle$ibilit' program used in this stud' is available else:here"*. Patients in the e$ercise group :ere instructed to perform the strengthening and fle$ibilit' e$ercises as a home program once dail'" Patients also :ere advised to maintain their usual activit' level :ithin the limits of pain" 3dvice to maintain usual activit' has been found to assist in the recover' from nec; pain"*) ** Patients :ere instructed to perform all activities that did not increase s'mptoms and to avoid activities that aggravated s'mptoms" Manipulation + exercise group. Dhe treatment received b' the manipulation + e$ercise group differed from that of the e$ercise5onl' group for the first :ee; onl' () treatment sessions)" >eginning in the third session these patients received the same treatment program outlined above for the e$ercise group (visits *7()" 6uring the first ) sessions patients in the manipulation + e$ercise group received thoracic spine thrust manipulations and a RIA e$ercise onl'" 3ll patients received * different thoracic spine thrust manipulations that :ere identical to those used in the derivation stud'" -( @e :ill use the model for describing thrust manipulations as recentl' proposed b' Aint;en et al*(N

-" 3 high5velocit' midrange distraction force to the midthoracic spine on the lo:er thoracic spine in a sitting position" Dhe therapist placed his or her upper chest at the level of the patientHs middle thoracic spine and grasped the patientHs elbo:s" 3 high5velocit' distraction thrust :as performed in an up:ard direction" )" 3 high5velocit' end5range anterior5posterior force applied through the elbo:s to the upper thoracic spine on the midthoracic spine in cervicothoracic fle$ion" Dhis technique :as performed :ith the patient positioned supine" Dhe therapist used his or her manipulative hand to stabili%e the inferior vertebra of the motion segment targeted and used his or her bod' to push do:n through the patientHs arms to perform a high5velocit' lo:5amplitude thrust" *" 3 high5velocit' end5range anterior5posterior force applied through the elbo:s to the middle thoracic spine on the lo:er thoracic spine in cervicothoracic fle$ion" Dhis technique :as performed :ith the patient positioned supine" Dhe therapist used his or her manipulative hand to stabili%e the inferior vertebra of the motion segment targeted and used his or her bod' to push do:n through the patientHs arms to perform a high5velocit' lo:5amplitude thrust" Eollo:ing the manipulations patients :ere given the same general cervical mobilit' e$ercise as in the derivation stud'" Dhe follo:ing e$ercise :as originall' described b' #rhard */ as a general mobilit' e$ercise for patients :ith nec; pain" Do perform this e$ercise each patient :as instructed to place the fingers over the manubrium" Dhe patient started :ith the chin on the fingers then rotated to one side as far as possible and returned to neutral" Dhis e$ercise :as performed alternatel' to both sides :ithin pain tolerance" Dhe patient started using ( fingers then progressed to . * ) and finall' - finger as mobilit' improved" Dhe patient :as as;ed to perform this e$ercise for -C repetitions to each side * to . times per da' :ithin pain tolerance each da' during participation in the stud'" Patients in this group also :ere advised to maintain usual activities that did not increase s'mptoms and to avoid all activities that e$acerbated their s'mptoms" 3t the third treatment session patients in the manipulation + e$ercise group began the e$ercise program listed above for the e$ercise5onl' group" Patients :ere treated t:ice a :ee; for the first :ee; and then once a :ee; for the ne$t * :ee;s for a total of ( therap' sessions" Identification of the Status on the Rule 3fter the patients completed the stud' the principal investigator determined each patientHs status on the rule using data collected at the initial evaluation" Using the same criteria identified in the initial stud' -( patients :ho met at least * of the follo:ing criteria :ere classified as li;el' responders (ie positive on the rule)" Patients :ho met ) or fe:er criteria :ere classified as li;el' nonresponders (ie negative on the rule)N -" E3>MP3 score Q-) points )" 6uration of current episode Q*C da's (judged from the patientHs self5report) *" 2o s'mptoms e$tending distal to the shoulder (judged from the pain diagram) ." 6ecreased cervical e$tension Q*C degrees (measured :ith a bubble inclinometer) (" 6ecreased D*7D( ;'phosis (identified during the postural e$amination) /" Patient reports that loo;ing up does not aggravate his or her s'mptoms (identified during the historical e$amination) Follow-up Eollo:5up assessments :ere performed after - :ee; (prior to treatment on the third visit) at . :ee;s (prior to treatment on the fifth visit) and at / months" 3t each follo:5up assessment patients completed the 26F 2PR, and ?RIC" 3ll patients attended the third visit allo:ing for data collection" Ff patients did not attend the fifth visit data :ere not collected for that follo:5up period"

Sample Size and Power @e based sample si%e calculation on detecting a clinicall' important difference in 26F score bet:een an' of the . cells of the stud' based on the patientsH status on the rule (positive or negative) and treatment group (manipulation + e$ercise or e$ercise onl') at an alpha level of "C(" >ased on our previous research -( :e e$pected a standard deviation of change scores on the 26F of -) points" Do detect a -C5point change in 26F at the -5:ee; follo:5up :ith 9(G po:er using a )5tailed h'pothesis and assuming a (CG distribution of patients*8 :ho do and do not meet the rule *C patients per cell :ere required" @e recruited -.C patients to permit appro$imatel' a -(G dropout rate or the possibilit' of unequal distribution of groups" Data nal!sis

@e e$amined the primar' aim using a linear mi$ed model :ith repeated measures to account for the correlation among repeated observations from the same patient" Dime treatment group and status on the rule as :ell as all possible )5:a' and *5:a' interactions :ere modeled as fi$ed effects :ith the 26F score as the dependent variable" 3 first5order auto5regressive covariance structure :as used for the repeated measures" Dhe primar' aim focused on evaluation of the *5:a' interaction among time treatment group and status on the rule" 3 separate model :as constructed in a similar fashion :ith pain (2PR,) as the dependent variable" ,imilarl' to investigate the secondar' aim of the stud' :e e$amined the )5:a' (time 0 group) interaction to determine :hether patients :ho received thoracic manipulation achieved superior outcomes regardless of status on the rule" @e also e$amined the )5:a' interaction bet:een status on the rule and time to determine :hether rule status :as an important prognostic factor regardless of treatment received" Dreatment effects :ere calculated from the bet:een5group differences in change score from baseline to the -5:ee; .5:ee; and /5month follo:5up periods" 3s a secondar' anal'sis :e e$amined the effects of treatment rule status and the interaction bet:een treatment and rule status at each follo:5up point using separate mi$ed model anal'ses :ith the 26F score at each follo:5up point as the dependent variable" Dreatment group rule status and the interaction bet:een treatment and rule status :ere included as fi$ed effects and the baseline 26F score :as included as a fi$ed effect covariate" ,imilar anal'ses :ere performed to e$amine 2PR, scores at each follo:5 up point" 2o patients :ere removed from the anal'sis for lac; of adherence to treatment procedures" Aissing data points :ere estimated in the mi$ed model anal'ses using restricted ma$imum li;elihood ratio estimation :ith -CC iterations" @e calculated the effect si%e using the Cohen d coefficient bet:een the manipulation + e$ercise and e$ercise5 onl' groups at each follo:5up period"*9 3n effect si%e of C") :as considered small C"( moderate and C"9 large"*9 @e also compared the number of successful outcomes bet:een groups" Patients :ho rated their perceived recover' on the ?RIC as Ka ver' great deal better L Ka great deal better L or Kquite a bit betterL (ie a score of +( or greater) at each follo:5up period :ere classified as having a successful outcome based on the initial stud'" -( Dhe percentage of patients e$periencing a successful outcome at each time period bet:een groups :as e$amined using a chi5square test of independence" @e then calculated the numbers needed to treat (22D) and J(G confidence intervals (CF) at the -5:ee; .5:ee; and /5month follo:5up periods" @e used an intention5to5treat anal'sis :ith patients anal'%ed in the group to :hich the' :ere allocated for the ?RIC anal'sis" Aissing data :ere replaced :ith the mean score of the respective group for each missing ?RIC value" 6ata anal'sis :as performed using ,P,, version -("R Role of the Funding Source Eunding :as provided b' the Eoundation for Ph'sical Dherap' and the Irthopaedic ,ection of the 3merican Ph'sical Dherap' 3ssociation" Dhe funding agenc' had no role in the stud' design :riting of the manuscript or the decision to submit the manuscript for publication" Previous ,ection2e$t ,ection

Results
D:o hundred sevent'5eight consecutive patients :ith nec; pain :ere screened for possible eligibilit'" Ine hundred fort' patients mean age *J"J 'ears (,6P--"*) (/JG female) satisfied the eligibilit' criteria and

agreed to participate" ,event' patients :ere randoml' assigned to receive manipulation and e$ercise and 8C patients :ere randoml' assigned to receive e$ercise onl'" Figure 1 sho:s a flo: diagram of patient recruitment and retention" >aseline variables for all groups are sho:n in Table 1" Recruitment of patients :as not equall' distributed among the participating clinics :ith rates of *.G )/G -JG -/G and (G across sites" Dhe overall long5term response rate :as 9-"CG" Dhe dropout rates :ere -.G (nP-C) for the manipulation + e$ercise group and )*G (nP-/) for the e$ercise5onl' group" 2o reasons :ere provided for the long5term follo:5up dropouts" 2o adverse events :ere reported for either group during the trial" 6isabilit' and pain scores for each follo:5up period are sho:n in Table 2"

Figure 1

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Elo: diagram of participant recruitment and retention" +CPRPpositive on the clinical prediction rule 7 CPRPnegative on the clinical prediction rule"
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Table 1 >aseline 6emographic and ,elf5Report Sariables for all Dreatment ?roups a
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Table 2 6isabilit' and Pain ,cores for 3ll ?roups at #ach Eollo:5up Perioda Repeated5measures anal'ses failed to reveal a significant *5:a' interaction for either 26F scores ( PP"8J) or 2PR, scores (PP")))" Dhis finding indicates that outcomes over time :ere not dependent upon the combination of a patientHs treatment group and status on the rule ( Figs 2 and !)" Aean scores for the 26F and pain for each treatment group relative to status on the rule are reported inTable 2"

 Figure 2

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Aean scores for the 2ec; 6isabilit' Fnde$ for each treatment group relative to status on the clinical prediction rule"

Figure !

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Aean scores for pain for each treatment group relative to status on the clinical prediction rule" Dhere :as a significant )5:a' interaction bet:een group and time for both the 26F ( PP"C-) and the 2PR, (PP"CC*)" Regardless of their status on the rule patients :ho received manipulation and e$ercise e$perienced greater improvements in disabilit' and pain across time than patients :ho received e$ercise alone" #stimated marginal means for the 26F b' group at each time period are graphed in Figure "" Dhere :ere no significant )5:a' interactions bet:een rule status and time for either disabilit' (PP"8-) or pain (PP")/) (Fig #)"

Figure "

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Aean scores for the 2ec; 6isabilit' Fnde$ b' group at each time period" 3steris; indicates statisticall' significant difference bet:een groups"

Figure #

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Aean scores for pain b' group at each time period" 3steris; indicates statisticall' significant difference bet:een groups" Results of the secondar' anal'ses e$amining the effects of treatment rule status and the interaction bet:een treatment and rule status at each follo:5up period demonstrated that the manipulation + e$ercise group e$perienced significantl' lo:er scores for disabilit' at - :ee; ( PP"CC*) . :ee;s (PP"CC-) and / months (PQ"CC-) and for pain at - :ee; (PQ"CC-) than patients :ho received e$ercise alone (Tab !)" Dhere :as a significant interaction bet:een status on the rule and treatment received for disabilit' at - :ee; ( PP"C--) and . :ee;s (PP"C() and the 2PR, score after - :ee; (PP"C-.)= ho:ever the differences :ere similar :hen compared :ith the manipulation + e$ercise intervention versus the e$ercise5onl' intervention a finding that does not support the value of the prediction rule (Fig !)"
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Table ! ,econdar' 3nal'ses #$amining the #ffects of Dreatment Rule ,tatus and the Fnteraction >et:een Dreatment and Rule ,tatus at #ach Eollo:5upa #ffect si%es for disabilit' at the -5:ee; .5:ee; and /5month follo:5up periods :ere C"(- C".9 and C"/( respectivel'" #ffect si%es for pain :ere C"(. for the -5:ee; follo:5up C"-9 for the .5:ee; follo:5up and C")( at the /5month follo:5up" Using an intention5to5treat anal'sis after - :ee; -9"(G (-*T8C) of the patients in the manipulation + e$ercise group achieved success :hich :as defined as having scores of +( or greater on the ?RIC compared :ith --".G (9T8C) of the patients in the e$ercise5onl' group" Dhere :as no statisticall' significant difference bet:een groups ( PP"-8)" 3fter . :ee;s a significant difference e$isted bet:een groups :ith (-".G (*/T8C) of the patients in the manipulation + e$ercise group and *-".G ())T8C) of the patients in the e$ercise5onl' group achieving success ( PP"C-)" Dhere also :as a significant difference bet:een groups at the /5month follo:5up period :ith 9CG ((/T8C) of patients in the manipulation + e$ercise group achieving success and *("8G ()(T8C) of the patients in the e$ercise5onl' group achieving success" Figure $ demonstrates the success rates across time for each group" Dhe 22D for the manipulation + e$ercise group :as -( (J(G CFPO."/ -9"J) at the -5:ee;5follo:5up / (J(G CFP-"J *."9) at the .5:ee; follo:5up and . (J(G CFP)"- 8"() at the /5month follo:5up"

 Figure $

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,uccess rates across time for each group" ,uccess :as defined as scoring +( or greater on the ?lobal Rating of Change scale" 3steris; indicates statisticall' significant difference bet:een groups" Previous ,ection2e$t ,ection

Discussion
Ft is essential to validate a CPR prior to incorporating it into :idespread clinical practice" -8 -9 Dherefore :e sought to e$amine :hether a previousl' derived CPR -( e$hibited validit' for identif'ing a subgroup of patients :ith nec; pain :ho responded favorabl' to thoracic manipulation" Dhe derived CPR :as based on the identification of clinical findings that predicted a good outcome in a cohort of patients :ith nec; pain :ho received thoracic manipulation" Salidation of a previousl' derived CPR needs to be performed using a stud' that includes randomi%ation to different treatments to determine :hether the clinical findings can be used to describe a subgroup of patients :ho preferentiall' respond to thoracic manipulation" Dhe current stud' sought to broadl' validate the CPR in a multi5site trial using a sound methodological design" *J Dhe results of this stud' generall' failed to validate the CPR" Dhe results of our stud' indicated that regardless of a patientHs status on the CPR those :ho received thoracic spine manipulation e$hibited reductions in pain at - :ee; and improvements in disabilit' at - :ee; . :ee;s and / months that :ere statisticall' significant" Dhe effect si%es for disabilit' :ere moderate at each follo:5up period and :ere moderate for pain at the -5:ee; follo:5 up" Dhe benefits of targeting manipulation to patients :ho :ere positive on the CPR :ere marginal and :ere evident onl' at the short5term (-5 and .5:ee;) follo:5ups" Ft does not appear that clinical decision ma;ing based on the CPR is li;el' to improve clinical outcomes= therefore the CPR cannot be advocated for adoption into clinical practice" Dhe results of this stud' suggest that short5 and long5term outcomes :ould be improved b' providing thoracic manipulation regardless of status on the CPR" Dhere are several reasons :h' a CPR that is derived in one cohort of patients :ith a single treatment arm ma' not be validated in a follo:5up clinical trial" Eirst findings in the derivation stud' ma' have been due to chance associations or to associations idios'ncratic to the original sample and therefore :ould not be replicated in a ne: sample of patients" -/ .C Ft also is possible that the clinicians in this stud' did not interpret or measure the clinical factors comprising the CPR in the same manner as the clinicians in the original stud'" Dhis possibilit' seems unli;el' due to the nature of the clinical factors in the CPR and their demonstrated interrater reliabilit'" 8 Einall' it is possible that a CPR derived from a single treatment arm stud' ma' be identif'ing factors that generall' identif' patients :ith a good prognosis but not specificall' related to receiving the treatment being studied"-/ Dhis possibilit' does not appear to have occurred in this instance because the current stud' did not identif' status on the CPR as related to prognosis" Ft seems most li;el' that the results of the derivation stud' :ere based on either chance associations or findings unique to the sample of patients in the original stud'" Dhe results of this stud' are in agreement :ith those of studies that e$amined the impact of thoracic spine manipulation in patients :ith acute or subacute mechanical nec; pain" ( .- .) Dhe current stud' also demonstrates that patients :ith nec; pain :ho received thoracic spine manipulation continued to e$perience greater improvements at the long5term follo:5up" Dhe minimal clinicall' important difference (ACF6) for the 26F has been reported to range from -CG to -JG" @e recogni%e that the differences bet:een groups although statisticall' significant did not surpass the ACF6" <o:ever the percentage of individuals :ho

e$perienced a successful outcome on the ?RIC :as significantl' greater in the manipulation + e$ercise group compared :ith the e$ercise5onl' group at . :ee;s and / months" 3dditionall' the 22D at the .5:ee; and /5month follo:5up periods :as / and . respectivel' providing further evidence for the use of thoracic spine manipulation in addition to e$ercise in this population" Dhis finding suggests that perhaps individuals :ith nec; pain :ho do not have an' contraindications to manipulation or meet an' of the e$clusion criteria should receive thoracic spine thrust manipulation regardless of additional factors in the clinical presentation" Ft also should be recogni%ed that a statisticall' significant interaction for pain occurred bet:een manipulation and status on the rule at the -5:ee; follo:5up period" 3lthough the treatment effects for reductions in pain for those :ho satisfied the rule at - :ee; :ere similar to those :hen comparing the manipulation + e$ercise and e$ercise5onl' groups :e feel the results of the current stud' do not :arrant utili%ation of the rule" Clinical prediction rules are valuable onl' if the' improve patient outcomes" -8 Dhe results of the current stud' suggest that using the rule does not improve patient care and that patients :ith nec; pain and no contraindications to manipulation should receive thoracic spine manipulation regardless of clinical presentation" 3 limitation of the current stud' is that although the e$ercise regimen :as based on current published guidelines no agreement e$ists as to the most effective e$ercises for the treatment of patients :ith nec; pain" Dherefore it is possible that different e$ercise approaches ma' have resulted in a different outcome" 3dditionall' although the distribution of patients :ho satisfied the rule :as close to our e$pected (CG in each treatment group future studies should consider using stratified randomi%ation to ensure equal distribution" Previous ,ection2e$t ,ection

"onclusion
Dhe results of the current stud' did not support the validit' of the previousl' developed CPR" -( <o:ever the )5:a' interaction bet:een group and time suggests that patients :ith mechanical nec; pain :ho do not e$hibit an' contraindications to manipulation e$hibit statisticall' significant improvements in disabilit' in both the short5 and long5term follo:5up periods"