phys ther 2012 macedo 363 77

doi: 10.2522/ptj.20110290Originally published online December 1, 2011

2012; 92:363-377.PHYS THER. Stanton and Ryan StaffordNicholas, Lois Tonkin, Chris J. Stanton, Tasha R.Maher, Paul W. Hodges, James H. McAuley, Michael K. Luciana Gazzi Macedo, Jane Latimer, Christopher G.Back Pain: A Randomized Controlled TrialActivity in Patients With Chronic Nonspecific Low Effect of Motor Control Exercises Versus Graded

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Effect of Motor Control ExercisesVersus Graded Activity in PatientsWith Chronic Nonspecific Low BackPain: A Randomized Controlled TrialLuciana Gazzi Macedo, Jane Latimer, Christopher G. Maher, Paul W. Hodges,James H. McAuley, Michael K. Nicholas, Lois Tonkin, Chris J. Stanton,Tasha R. Stanton, Ryan Stafford

Background. Motor control exercises to improve control and coordination oftrunk muscles and graded activity under the principles of cognitive-behavioral ther-apy are 2 commonly used exercise therapies, yet there is little evidence to supportthe use of one intervention over the other.

Objective. The objective of this study was to compare the effectiveness of motorcontrol exercises and graded activity for patients with chronic nonspecific low backpain.

Design. This study was a prospectively registered randomized controlled trial withoutcome assessment and statistical analyses conducted blind to group.

Setting. The study was conducted in primary care settings.

Patients. The participants were 172 patients with chronic (�12 weeks) non-specific low back pain.

Interventions. Patients were randomly assigned to receive either motor controlexercises or graded activity. There was no attempt to subclassify patients to matchthem to a treatment. Patients in both groups received 14 sessions of individualized,supervised exercise therapy.

Measurements. Primary outcomes were average pain over the previous week(numeric rating scale) and function (Patient-Specific Functional Scale); secondaryoutcomes were disability (24-item Roland-Morris Disability Questionnaire), globalimpression of change (Global Perceived Effect Scale), and quality of life (36-ItemShort-Form Health Survey questionnaire [SF-36]). Outcome measures were collectedat baseline and at 2, 6, and 12 months after intervention.

Results. A linear mixed models analysis showed that there were no significantdifferences between treatment groups at any of the time points for any of theoutcomes studied. For example, the effect for pain at 2 months was 0.0 (�0.7 to 0.8).

Limitations. Clinicians could not be blinded to the interventions.

Conclusion. The results of this study suggest that motor control exercises andgraded activity have similar effects for patients with chronic nonspecific low backpain.

L.G. Macedo, PT, PhD, CommonSpinal Disorders Research Group,Department of Physical Therapy,University of Alberta, 2-50 Cor-bett Hall, Edmonton, Alberta,Canada T6G 2G4. Address all cor-respondence to Dr Macedo at:[email protected].

J. Latimer, PT, PhD, Musculoskele-tal Division, The George Institutefor Global Health, Sydney, NewSouth Wales, Australia.

C.G. Maher, PT, PhD, Musculo-skeletal Division, The George Insti-tute for Global Health.

P.W. Hodges, PT, PhD, NHMRCCentre of Clinical ResearchExcellence in Spinal Pain, Injuryand Health, The University ofQueensland, Brisbane, Queens-land, Australia.

J.H. McAuley, PhD, NeuroscienceResearch Australia, Sydney, NewSouth Wales, Australia.

M.K. Nicholas, PhD, Pain Man-agement Research Institute, TheUniversity of Sydney at RoyalNorth Shore Hospital, Sydney,New South Wales, Australia.

L. Tonkin, BScPT, Pain Manage-ment Research Institute, The Uni-versity of Sydney at Royal NorthShore Hospital.

Author information continues onnext page.

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Supervised exercise therapiesare among the most commonlyadvocated treatments for chronic

nonspecific low back pain.1,2 How-ever, despite the growing number ofstudies evaluating the effectiveness ofexercise interventions, there is stillconsiderable debate with regard tothe most appropriate form of exer-cise.3 Systematic reviews evaluatingthe effectiveness of exercise thera-pies commonly conclude that, todate, there is no evidence to supportthe superiority of one form of exer-cise over another.3–5

Among the wide variety of super-vised exercise therapies available,motor control exercises and gradedactivity under the principles ofcognitive-behavioral therapy are themost popular and promising formsof exercise for patients with chroniclow back pain.1,3,6 The primary rea-son for their popularity is that, unlikesome other forms of exercise, eachhas a specific rationale for its mech-anisms of action in addition to evi-dence of their efficacy from random-ized controlled trials and systematicreviews.4,5 For these reasons, manyhealth professionals believe thatthese 2 forms of exercise may havesuperior effects compared withother forms of exercise therapy.

Motor control exercises were devel-oped based on the results of labora-tory studies demonstrating that indi-viduals with low back pain haveimpaired control of the deep (eg,transversus abdominis and multifi-dus) and superficial trunk musclesresponsible for maintaining the sta-bility of the spine.7–10 Motor controlexercises utilize principles of motorlearning to retrain control of the trunkmuscles, posture, and movement pat-tern,11 ultimately leading to a reduc-tion in the levels of pain and disability.

Graded activity exercises weredeveloped based on studies suggest-ing that cognitive-behavioral aspects,

such as the patient’s mood and cog-nition, are important factors associ-ated with delayed recovery fromback pain and with increased levelsof disability in patients with chronicpain.12–17 This cognitive-behavioralmodel assumes that disability isdetermined not only by the underly-ing pathology, but also by social,cognitive, emotional, and behavioralfactors.18 Therefore, graded activityexercises aim to reduce pain and dis-ability by addressing pain-relatedfear, kinesiophobia, and unhelpfulbeliefs and behaviors about backpain19 while correcting physicalimpairments such as reduced endur-ance, muscle strength, or balance.20

Systematic reviews have suggestedthat motor control exercise andgraded activity are effective in reduc-ing pain and disability in patientswith nonspecific low back paincompared with a minimal interven-tion approach.4,5 However, only onestudy has directly compared theeffectiveness of motor control exer-cises and graded activity.21 Thisrandomized controlled trial showedno significant differences betweengroups in relation to pain or disabilityat 6-, 12-, and 18-month follow-ups;however, the study had more than22% loss to follow-up in both groups,which decreases confidence in theresults. In addition, the trial protocolwas not registered or published priorto beginning data collection, andboth interventions were adminis-tered in a group format that may notbe considered an optimal way toimplement these interventions.22

Motor control exercises and gradedactivity are used in clinical practice,although limited information is avail-able to guide clinical decision mak-ing. In view of the limitations of theonly trial that compared the effec-tiveness of these 2 interventions, webelieved it was imperative to con-duct a high-quality randomized con-trolled trial where the 2 exercise pro-

C.J. Stanton, BSc, Musculoskeletal Division,The George Institute for Global Health.

T.R. Stanton, PT, PhD, The Sansom Institutefor Health Research, The University of SouthAustralia, Adelaide, South Australia, Austra-lia, and Neuroscience Research Australia.

R. Stafford, NHMRC Centre of ClinicalResearch Excellence in Spinal Pain, Injuryand Health, The University of Queensland.

[Macedo LG, Latimer J, Maher CG, et al.Effect of motor control exercises versusgraded activity in patients with chronic non-specific low back pain: a randomized con-trolled trial. Phys Ther. 2012;92:363–377.]

© 2012 American Physical Therapy Association

Published Ahead of Print: December 1, 2011Accepted: October 22, 2011Submitted: September 6, 2011

Motor Control Versus Graded Activity for Low Back Pain

364 f Physical Therapy Volume 92 Number 3 March 2012 by guest on December 21, 2014http://ptjournal.apta.org/Downloaded from


grams could be directly compared inpatients with chronic nonspecificlow back pain.

MethodDesign OverviewThis study was a randomized con-trolled trial where patients receivedan intervention for approximately8 weeks, with follow-ups at 2, 6,and 12 months after intervention.This trial was prospectively registered(ACTRN12607000432415), and theprotocol has previously been pub-lished.23 All patients signed aninformed consent form prior to theirinclusion into the study.

Setting and PatientsParticipants were recruited to thetrial by general practitioners in Syd-ney and Brisbane or drawn fromthe waiting list of an outpatient phys-ical therapy department from a pub-lic hospital in Sydney. Five patientswere recruited by one of the investi-gators, who identified eligible patientswho responded to an advertisementfor participation in another set ofstudies of back pain in Brisbane.

Patients were eligible for inclusion ifthey met all of the following inclu-sion criteria:

• chronic nonspecific low back pain(�3 months’ duration) with orwithout leg pain

• currently seeking care for low backpain

• between 18 and 80 years of age• English speaker (to allow response

to the questionnaires and com-munication with the physicaltherapist)

• clinical assessment indicated thatthe patient was suitable for activeexercises

• expected to continue residing inthe Sydney or Brisbane region forthe study duration

• had a score of moderate or greateron question 7 (“How much bodilypain have you had during the past

week?”) or question 8 (“During thepast week, how much did paininterfere with your normal work,including both work outside thehome and housework?”) of the36-Item Short-Form Health Surveyquestionnaire (SF-36).24

Exclusion criteria were:

• known or suspected serious pathol-ogy such as nerve root compromise(at least 2 of the following signs:weakness, reflex changes, or sensa-tion loss, associated with the samespinal nerve)

• previous spinal surgery or sched-uled for surgery during trial period

• comorbid health conditions thatwould prevent active participationin exercise programs.

We used a “red flag” checklist toscreen for serious pathology and thePhysical Activity Readiness Ques-tionnaire from the American Collegeof Sports Medicine guidelines25 toscreen for comorbid health condi-

tions that would prevent safe par-ticipation in exercise.

Randomizationand InterventionsThe randomization sequence wascomputer generated by an investi-gator not involved in recruitmentor treatment allocation. Two setsof randomization schedules werecreated: one for the patients to berecruited in Sydney (100 envelopes)and one for patients to be recruitedin Brisbane (72 envelopes). Bothsequences were blocked (blocksizes of 4, 6, and 8, in randomorder). Allocation was concealedin sequentially numbered, sealed,opaque envelopes by an investigatornot involved in the study. Eligiblepatients were allocated to the treat-ment groups by the physical thera-pist who drew the next availableenvelope at the first treatment ses-sion. Because of time constraints dueto funding and because we were ableto recruit more participants in Syd-ney than in Brisbane, the last 33 ran-

The Bottom Line

What do we already know about this topic?

Motor control exercises to improve control and coordination of trunkmuscles and graded activity under the principles of cognitive-behavioraltherapy are 2 commonly used exercise therapies for chronic nonspecificlow back pain, yet there is little evidence to support the use of oneintervention over the other.

What new information does this study offer?

The results of this randomized controlled trial suggest that motor controlexercises and graded activity have similar effects on the general popula-tion of patients with chronic nonspecific low back pain.

If you’re a patient or a caregiver, what might thesefindings mean for you?

Well-designed and well-implemented exercise programs are an effectivetreatment for chronic low back pain, but the type of exercise does notseem to be particularly important. Your physical therapist might prescribeeither exercise program for your low back pain.




domization envelopes initially allo-cated to Brisbane were transferred tothe Sydney site. No attempt wasmade to evaluate the effect of site ontrial outcomes.

Participants in each group were toreceive 14 individually supervisedsessions of approximately 1 hour.The treatment consisted of 12 initialtreatment sessions over an 8-weekperiod and 2 booster sessions at 4and 10 months following randomiza-tion. The initial 12 sessions wereconducted twice a week for the first4 weeks and once a week for thefollowing 4 weeks. The treatmentsessions were designed to becomeless frequent and promote indepen-dence. In order to facilitate adher-ence to treatment sessions and to beconsistent with clinical practice, ifpatients could not complete the ini-tial 12 treatment sessions within thefirst 8 weeks, they received an exten-sion of another 4 weeks to completethe 12 treatment sessions. Patientsincluded in both exercise programswere advised to do home exercisesfor at least half an hour per week inthe first month and 1 hour per weekin the second month. The type ofhome exercises, intensity, and num-ber of sessions per day were at thediscretion of the physical therapist.

Trial interventions were providedby 10 physical therapists with atleast 2 years of clinical experiencewho received training in motor con-trol exercises and graded activity.Therefore, all therapists providedboth interventions. The trainingincluded a 2-day workshop for themotor control exercises and a seriesof evening interactive seminars forgraded activity, both administeredby recognized experts in the field.The same experts performed auditsof trial treatment of most of thetreating physical therapists to evalu-ate and encourage compliance withthe treatment protocols. Althoughwe do not have the specific data nec-

essary to evaluate the physical ther-apists’ compliance with the treat-ment protocols, our audits revealedthat most physical therapists fol-lowed the treatment protocols andthere was no evidence of cross-contamination. The physical thera-pists worked at private clinical prac-tices or at the university clinic.

Motor Control ExercisesThe motor control exercise programwas based on the treatment pro-gram reported by Hodges et al11 andsimilar to the protocol previouslyused by Ferreira et al26 and Costaet al.27 A primary goal of the exercisewas to enable the patient to regaincontrol and coordination of thespine and pelvis using principles ofmotor learning such as segmentationand simplification. The interventionwas based on assessment of the indi-vidual participant’s motor controlimpairments and treatment goals (setcollaboratively with the therapist).

The first stage of the treatmentinvolved assessment of the postures,movement patterns, and muscle acti-vation associated with symptomsand implementation of a retrainingprogram designed to improve activ-ity of muscles assessed to have poorcontrol (commonly, but not limitedto, the deeper muscles such as trans-versus abdominis, multifidus, pelvicfloor, and diaphragm) and reducingactivity of any muscle identified tobe overactive, commonly the large,more superficial trunk muscles suchas the obliquus externus abdomi-nis.11 Participants were taught howto contract trunk muscles in a spe-cific manner26,27 and progress untilthey were able to maintain isolatedcontractions of the target musclesfor 10 repetitions of 10 seconds eachwhile maintaining normal respira-tion.28 Feedback such as palpationand real-time ultrasound imageswere available to enhance learningof the tasks.29 During this stage, addi-tional exercises for breathing con-

trol, posture of the spine, and lower-limb and trunk movement wereperformed.

The second stage of the treatmentinvolved the progression of the exer-cises toward more functional activi-ties,27 first using static and thendynamic tasks. Throughout this pro-cess, the recruitment of the trunkmuscles, posture, movement pat-tern, and breathing were assessedand corrected.11 In contrast to thegraded activity program, motor con-trol exercise was guided by pain, andexercises were mostly pain-free.

Graded ActivityThe graded activity program wasbased on the treatment programoriginally reported by Lindstrom etal30 and similar to the protocol pre-viously used by Pengel et al31 andSmeets et al.32 A primary goal of theprogram was to increase activity tol-erance by performing individual-ized and submaximal exercises,31

in addition to ignoring illness behav-iors and reinforcing wellness behav-iors. The program was based onactivities that each participant iden-tified as problematic and that heor she could not perform or haddifficulty performing because ofback pain. The activities in the pro-gram were progressed in a time-contingent manner (rather than a tra-ditional pain-contingent manner)from the baseline-assessed ability toa target goal set jointly by partici-pant and therapist.30,33,34 Partici-pants received daily quotas andwere instructed to only perform theagreed amount, not less or more,even when they felt they were capa-ble of doing more.32

Cognitive-behavioral principles wereused to help the participants over-come the natural anxiety associ-ated with pain and activities.33,35

The physical therapists used posi-tive reinforcement, explained painmechanisms, and addressed negative




behaviors and pain-related anxiety.33

A plan for managing relapses wasdeveloped by the therapists and par-ticipants. Table 1 describes specificdifferences between motor controlexercises and graded activity.

Outcome Measuresand Follow-upAll self-reported measures were col-lected by an investigator blindedto treatment allocation. Measuresof outcome were obtained at base-line, immediately after treatment(2 months), and at 6 months and12 months after randomization.Demographic characteristics such asage, sex, weight, height, level of edu-cation, and employment status werecollected at baseline. We also col-lected information on psychologicalprofile, physical activity, and lumbarspine instability using self-reportquestionnaires at baseline. Thesequestionnaires included the CopingStrategy Questionnaire,36 the OrebroLow Back Pain Screening Question-naire,37 the 20-item Pain AnxietySymptom Scale (PASS-20),38 the PainSelf-Efficacy Questionnaire,39 theInternational Physical Activity Ques-tionnaire (IPAQ),40 and the LumbarSpine Instability Questionnaire.41

Primary outcomes were averagepain intensity over the last week(0–10 numeric rating scale [NRS])42

and function (0–10 Patient-SpecificFunctional Scale [PSFS]) at the 2-and 6-month follow-ups (the12-month scores for these outcomeswere considered secondary out-comes).43 Secondary outcomes wereglobal impression of change (�5to 5 Global Perceived Effect Scale),43

disability (0–24 Roland-Morris Dis-ability Questionnaire),44 and qualityof life (SF-36, version 1.0)24 reportedas physical component score (0–100) and mental component score(0–100) when standardized usingthe SF-36 Australian PopulationNorms values for mean and standarddeviation45 measured at 2, 6, and 12

months. Because of a printing error,there were only 5, not 6, responseoptions for question 9 of the SF-36(ie, the option “some of the time”was inadvertently omitted). How-ever, the summary scores were stillcalculated as per the SF-36 manual.

In addition, we measured recovery,defined as a pain-free period thatlasted for at least 1 month.46 Infor-mation about side effects was col-lected using an open-ended question

(“Have you experienced any sideeffects during your 8-week treat-ment?”). Participants rated the cred-ibility of treatment (0–24 treatmentcredibility scale)47 after the firsttreatment session to allow an evalu-ation of whether patients’ expecta-tions and beliefs were differentbetween treatment groups. At theend of the treatment, participantsalso rated how helpful, understand-ing, and friendly they found the ther-apists on a 7-point scale.31 Adher-

Table 1.Differences Between Motor Control Exercise and Graded Activitya

Principles of the InterventionsGradedActivity

MotorControlExercise

Goal setting � �

Pain contingent �

Time contingent �

Quotas/pacing �

Reinforce wellness behavior and ignore illnessbehavior

�

Education regarding pain system and reassurance � �

Education regarding ergonomic factors and bodyawareness

� �

Generalized (whole body) exercises withconsideration of specific muscle activity

�

Generalized (whole body) exercises withoutconsideration of specific muscle activity

�

Specific (localized) exercises �

Focus on correct activation of muscles �

Correction of posture �

Strength training � �

Cardiovascular/fitness training � �

Coordination training �

Correction of motor patterns �

Muscle stretching � �

Breathing pattern �

Consideration of continence �

Correction of provocative movement patterns �

Relaxation techniques �

Progression to functional activities � �

Use feedback (eg, ultrasound, electromyography,biofeedback) to enhance learning ofmovement pattern or muscle activation

�

Home exercises � �

a Check mark indicates principle applies to the intervention.




ence to home exercises was assessedusing a single question: “How oftenhave you done your home programof exercises (all the time, most of thetime, some of the time, a little of thetime, or none of the time)?”

We also asked participants abouttheir pain every month over the 12months of the study to evaluate thefluctuating nature of chronic pain.Participants were asked about theirpain at baseline and once a monthduring the 1-year follow-up period.The data were collected using anautomated SMS system. All messagesconsisted of the following text:“Please rate on a 0 to 10 scale (0�nopain, 10�worst pain): (a) averagepain over the last 24 hours and(b) average pain over the previousweek.” The automated system wasscheduled to send an SMS message at10 a.m. every first, second, third, orfourth Monday of the month accord-ing to the week that the participantentered the study. If patients did notreply to the first message, anothermessage was sent on the next day atthe same time. The same procedurewas performed for the followingday. Therefore, each participant had3 chances to respond to the mes-sages. The automated system alsosent an e-mail to the project coordi-nator with the names of the partici-pants who had not responded toeach of the rounds of questions. Ifthe participants did not respond tothe third message, they were con-tacted via telephone to respond tothe questions.

Data AnalysisThe sample size of 172 participantswas calculated a priori based on thesecondary goal of the study, notreported in this article, which wasto identify predictors of response totreatment. As larger sample sizes areneeded for evaluating interactions ascompared with main effects of stud-ies, this study may have been over-powered for the main effects.23 Tak-

ing the standard deviation estimatesfrom previous studies,26,31 with analpha level of .05 and power of 0.80and allowing for 10% loss tofollow-up and 10% treatment nonad-herence, a sample size of 86 partici-pants per group would allow us todetect an interaction effect size of1.0 standard deviation and a treat-ment main effect of 0.5 standarddeviation.

All data were double-entered, andanalyses were performed on a lockeddata file. The statistical analyses wereperformed using SPSS version 16.0for Windows (SPSS Inc, Chicago, Illi-nois) and STATA version 9.0 (Stata-Corp LP, College Station, Texas) (lin-ear mixed models) on an intention-to-treat basis. The investigatorperforming the analyses was blindedto treatment allocation, and allanalyses were double-checked by asecond blinded investigator. Afterthe study team had considered theresults of the statistical analysesand agreed on their interpretation,the results were unblinded. Inde-pendent t tests were used to deter-mine whether there were significantdifferences in treatment credibilityand treatment evaluation betweengroups.

The mean effect of intervention onpain, function, disability, global per-ceived effect, and quality of life(divided into physical and mentalcomponent scores) was calculatedusing linear mixed models, whichincorporated terms for treatment,time, and treatment � time interac-tions. Because the linear mixedmodel estimates values for missingdata, all randomized participantswere included in the analysis.48 Theeffect of time was nonlinear, so timewas dummy coded and analyzed as acategorical variable. The coefficientsof the treatment � time interactionsprovided the effects of graded activ-ity over motor control exercise.

After inspecting the blinded recov-ery data, we realized that there werelimitations with our preplanned mea-sure of recovery. The challenge wasthat a number of participants whomet the definition of recovery (pain-free for 1 month) had a recurrence inthe follow-up period. Because thereis a lack of consensus in the literatureregarding a standardized definitionof recovery,49 we developed 2 meth-ods to define recovery. The first,stricter measure was “durable recov-ery,” which required participants toreport no pain for at least 2 monthsand no recurrence of pain over the12 months of the study. The second,more relaxed, method classifiedparticipants as recovered if theyreported pain of 1 or less for any ofthe SMS responses referring to painin the preceding week. Both classifi-cation methods were used to identifyparticipants who had recovered. Dif-ferences in recovery proportionsbetween treatment groups were ana-lyzed using absolute risk reductionand the Wilson method for calculat-ing 95% confidence interval (CI) fordifference in proportions.

For the secondary outcome of painmeasured using SMS over the 12months of the study, we estimatedthe effect of treatment with agroup � time interaction in a linearmixed model. Time was entered inthe model as log of time and wastreated as a continuous variable. Wealso plotted the SMS pain measuresover time and calculated the areaunder the curve (AUC) for each par-ticipant (AUC values could rangefrom 0 to 120 units, representingpain on the y axis and the 12 timefollow-ups on the x axis). We usedan independent t test to determinewhether the AUC was differentbetween treatment groups.

Role of the Funding SourceThis trial received funding from Aus-tralia’s National Health and MedicalResearch Council. The funding




source had no role in the planning orconduct of the study.

ResultsA total of 355 patients were referredto the study and screened for inclu-sion between October 2007 andNovember 2009. One hundred fourpatients were not eligible, and 79refused to participate. Reasons forineligibility are presented in Table 2.The trial participant flowchart is pre-sented in Figure 1. Nine participantswithdrew from the study: 2 fromthe graded activity group (1 for notimproving and 1 unknown) and 7from the motor control exercisegroup (2 for lack of time, 1 for notimproving, 1 developed neurologi-cal signs, 1 was not happy with thestudy protocol, and 2 unknown). Interms of loss to follow-up, the mainreasons were the participant’s lackof time and inability to contact theparticipant. We did not identify sig-nificant differences at baseline forthe participants who withdrew orwere lost to follow-up. Baseline char-acteristics, including demographicsand baseline scores for both treat-ment groups, are reported in Table 3and revealed that the randomiza-tion achieved groups that were wellbalanced for important prognosticfactors.

Adherence to treatment in the ini-tial 8-week period was excellent,with both groups attending a meanof 10.3 (SD�3.6) of the planned 12sessions. However, treatment adher-ence was lower for the 2 boostertreatment sessions and the homeprogram. Forty-three percent of theparticipants in the graded activityexercise attended the 4-monthbooster treatment session and 31.4%attended the 10-month booster treat-ment session. In the motor controlexercise group, attendance was 50%and 25.6%, respectively. Participantsin the graded activity group reportedperforming their home exercises: allthe time (23%), most of the time

(44%), some of the time (19%), alittle of the time (6%), and none ofthe time (2%). Participants in themotor control exercise groupreported performing home exer-cises: all the time (15%), most ofthe time (42%), some of the time(26%), a little of the time (5%), andnone of the time (1%).

Treatment credibility measured afterthe first treatment session and treat-ment evaluation at the end of thetreatment were not significantly dif-ferent between treatment groups(P�.05 for all comparisons). Themean score for treatment credi-bility was 19.8 (SD�3.6) for thegraded activity group and 19.4(SD�4.1) for the motor controlexercise group (treatment credi-bility scored from 0 [“not confi-dent that treatment can help”] to 24[“extremely confident that treatmentcan help”]). Mean scores for treat-ment evaluation (scale range: 0 [notat all] to 6 [extremely]) in the gradedactivity and motor control exercisegroups were 5.3 (SD�1.0) and 5.2(SD�1.0), respectively, for therapisthelpfulness; 5.6 (SD�0.7) and 5.4(SD�1.0), respectively, for therapistunderstanding; 5.9 (SD�0.4) and 5.7

(SD�0.7), respectively, for therapistfriendliness; and 4.7 (SD�1.2) and4.7 (SD�1.5), respectively, for treat-ment helpfulness.

Ten, 5, and 8 participants in thegraded activity group and 6,17, and 9 participants in the motorcontrol exercise group reportedreceiving cointerventions in addi-tion to the trial treatment at the 2-,6-, and 12-month follow-ups, respec-tively. Mild adverse effects werereported for 17 participants in thegraded activity group and 19 partic-ipants in the motor control exer-cise group. Adverse effects were:temporary exacerbation of pain(n�27), increased pain of pre-existing musculoskeletal conditionssuch as knee arthritis (n�7), devel-opment of shin splints (n�1), andhip bursitis (n�1). One participantin the graded activity group reportedat the 6-month follow-up an exacer-bation of symptoms that the medicalpain specialist attributed to one ofthe home exercises that the partici-pant was performing.

The estimates of treatment effectsfrom the linear mixed modelsrevealed that there were no statisti-

Table 2.Reasons for Ineligibility

Reason n

Low back pain of less than 3 months’ duration 30

Non-English speaker 13

Not expected to continue residing in the study area 12

Less than moderate pain or disability on question 7 or 8 of the SF-36a 11

Pain in a location other than the lower back 9

Nerve root compromise 8

Younger than 18 or older than 80 years of age 6

Suspected or confirmed serious pathology such as fracture or cancer 4

History of back surgery 4

Judged not fit to perform physical exercise 3

Not able to contact patient 3

Already undergoing treatment 1

a SF-36�36-Item Short-Form Health Survey questionnaire.




Analyzedn=86

Analyzedn=86

75 (87.2%) were followed up at 12 months80 (93.0%) were followed up at 12 months

Lost to follow-up (n=6; 2 withdrew fromstudy, 1 lack of time, 3 unknown)

81 (94.2%) were followed up at 6 months



Lost to follow-up (n=4; 2 withdrew fromstudy, 2 unknown reason)

Care providers performing the intervention(n=8)

No. of patients treated by each care provider(median=3.5, IQR=5.5)

Graded activity group=86(Sydney=65, Brisbane=21)

All commenced allocated intervention

79 refused to participate104 ineligible

355 patients referredto the study

Randomizationn=172


Allocation

Care providers

Analyses

2-monthfollow-up

6-monthfollow-up

12-monthfollow-up

Discontinued intervention (n=2; 1 notimproving, 1 unknown

Median=12 (4.25) treatments completed

Lost to follow-up (n=11; 7 withdrew fromstudy, 4 not able to contact)

Lost to follow-up (n=12; 7 withdrew fromstudy, 3 not able to contact, 2 lack of time)



Care providers performing the intervention(n=10)

No. of patients treated by each care provider(median=9, IQR=5.5)

Motor control exercise group=86(Sydney=68, Brisbane=18)

All commenced allocated intervention

Discontinued intervention (n=8; 3 lack oftime, 1 not improving, 1 developedneurological signs, 1 not happy with studyprotocol, 2 unknown)

Median=13 (5.25) treatments completed

)

Figure 1.Study flow diagram. IQR�interquartile ratio.




Table 3.Baseline Characteristics

CharacteristicGraded Activity Group

(n�86)Motor Control Exercise Group

(n�86)

Age (y), X (SD) [range] 49.6 (16.3) [18–80] 48.7 (13.7) [20–75]

Female, n (%) 45 (52.3) 57 (66.3)

Height (cm), X (SD) 168.5 (10.1) 166.9 (9.2)

Weight (kg), X (SD) 80.8 (16.2) 75.7 (19.3)

Smoker, n (%) 14 (16.3) 16 (18.6)

Taking analgesics, n (%) 57 (66.3) 52 (60.5)

Low back pain duration (mo), X (SD) 100.7 (109.2) 74.0 (94.8)

Previous episode of low back pain, n (%) 57 (66.3) 54 (62.8)

Work status, n (%)

Working full-time 23 (26.7) 25 (29.1)

Working full-time, selected duties 1 (1.2) 4 (4.7)

Working part-time 16 (18.6) 18 (20.9)

Working part-time, selected duties 3 (3.5) 5 (5.8)

Not working 9 (10.5) 11 (12.8)

Not seeking employment 34 (39.5) 23 (26.7)

Education, n (%)

School certificate 15 (17.4) 14 (16.3)

High school certificate 24 (27.9) 16 (18.6)

Trade certificate, diploma, or advanced diploma 17 (19.8) 31 (36.1)

Bachelor’s degree or higher 20 (23.3) 19 (22.1)

Other (lower than school certificate) 8 (9.3) 4 (4.7)

Questionnaires, X (SD)

Coping Strategy Questionnairea 10.8 (7.6) 12.4 (7.5)

Orebro Low Back Pain Screening Questionnaireb 103.4 (26.9) 102.8 (20.4)

Pain Anxiety Symptom Scale

Total scorec 40.1 (21.8) 44.8 (21.0)

Cognitived 12.6 (7.1) 13.7 (6.3)

Escape/avoidanced 12.7 (6.3) 13.2 (6.0)

Feard 8.5 (6.6) 10.2 (6.6)

Physiological anxietyd 6.5 (5.6) 7.7 (5.8)

Pain Self-Efficacy Questionnairee 40.9 (13.5) 38.7 (12.3)

International Physical Activity Questionnairef 3,196 (6,634.9) 4,603.7 (8,012.4)

Lumbar Spine Instability Questionnaireg 9.0 (3.1) 9.0 (2.7)

Outcome scores, X (SD)

Pain intensity (NRS)h 6.1 (2.1) 6.1 (1.9)

Function (PSFS)i 3.6 (1.6) 3.7 (1.6)

Disability (RMDQ-24)j 11.2 (5.3) 11.4 (4.8)

Global impression of change (GPE)k �1.6 (2.6) �1.4 (2.3)

SF-36 physical component scorel 43.8 (10.3) 43.9 (10.8)

SF-36 mental component scorem 54.7 (11.5) 52.9 (10.5)

a Coping Strategy Questionnaire scored from 0 (good coping strategy) to 36 (worst coping strategy).b Orebro Low Back Pain Screening Questionnaire scored from 11 (low risk of pain becoming persistent) to 192 (high risk of pain becoming persistent).c Pain Anxiety Symptom Scale total score, scored from 0 (low anxiety) to 100 (high anxiety).d Pain Anxiety Symptom Scale subscales of cognition, escape/avoidance, fear, and physiological anxiety, scored from 0 (low cognition, escape/avoidance,fear, and physiological anxiety) to 25 (high cognition, escape/avoidance, fear, and physiological anxiety).e Pain Self-Efficacy Scale scored from 0 (high fear avoidance) to 100 (no fear avoidance).f International Physical Activity Questionnaire scored in metabolic equivalents-minutes/week.g Lumbar Spine Instability Questionnaire scored from 0 (no instability) to 15 (high instability).h NRS�numeric rating scale, scored from 0 (no pain) to 10 (worst pain).i PSFS�Patient-Specific Functional Scale, scored from 0 (unable to perform activity) to 10 (able to perform activity at preinjury level).j RMDQ-24�24-item Roland Morris Disability Questionnaire, scored from 0 (no disability) to 24 (high disability).k GPE�Global Perceived Effect Scale, scored from �5 (vastly worse) to 5 (completely recovered).l Physical component score from the 36-Item Short-Form Health Survey questionnaire (SF-36) scored from 0 (low physical health) to 100 (high physicalhealth).m Mental component score from the SF-36 scored from 0 (low mental health) to 100 (high mental health).




Table 4.Outcomes for Each Treatment Group (Primary Outcomes in Bold Type)

Outcome

Unadjusted X (SD) Adjusted Treatment Effects

GradedActivity Group

Motor ControlExercise Group X (95% CI)a P

Pain (NRS)b

Baseline 6.1 (2.1) 6.1 (1.9) n/ac n/a

2 mo 4.1 (2.5) 4.1 (2.5) 0.0 (�0.7 to 0.8) .94

6 mo 4.1 (2.7) 4.1 (2.5) 0.0 (�0.8 to 0.8) .99

12 mo 3.7 (2.6) 3.7 (2.7) 0.1 (�0.7 to 0.9) .83

Function (PSFS)d

Baseline 3.6 (1.6) 3.7 (1.6) n/a n/a

2 mo 5.5 (2.4) 5.9 (2.1) 0.2 (�0.5 to 0.9) .53

6 mo 5.7 (2.4) 5.7 (2.3) �0.2 (�0.9 to 0.5) .53

12 mo 6.1 (2.3) 5.9 (2.2) �0.4 (�1.1 to 0.3) .25

Disability (RMDQ-24)e

Baseline 11.2 (5.3) 11.4 (4.8) n/a n/a

2 mo 8.0 (6.5) 7.5 (6.4) �0.8 (�2.2 to 0.7) .30

6 mo 8.6 (6.8) 8.0 (7.1) �0.8 (�2.3 to 0.6) .26

12 mo 8.0 (6.9) 7.4 (6.7) �0.6 (�2.0 to 0.9) .45

Global impression of change (GPE)f

Baseline �1.6 (2.6) �1.4 (2.3) n/a n/a

2 mo 2.0 (1.9) 2.0 (1.9) �0.1 (�1.0 to 0.7) .74

6 mo 1.5 (2.5) 1.6 (2.4) 0.0 (�0.9 to 0.8) .91

12 mo 1.5 (2.5) 1.8 (2.5) 0.2 (�0.6 to 1.0) .62

SF-36 physical component scoreg

Baseline 43.8 (10.3) 43.9 (10.8) n/a n/a

After treatment (�2 mo) 51.6 (13.4) 51.6 (12.0) �0.2 (�3.7 to 3.2) .89

6 mo 51.2 (13.8) 52.6 (13.0) 1.1 (�2.4 to 4.6) .54

12 mo 53.3 (14.0) 53.8 (12.7) �0.3 (�3.8 to 3.3) .88

SF-36 mental component scoreh

Baseline 54.7 (11.5) 52.9 (10.5) n/a n/a

2 mo 55.8 (13.0) 56.0 (10.9) 2.3 (�0.7 to 5.3) .14

6 mo 56.9 (11.8) 54.9 (10.4) 0.1 (�3.0 to 3.1) .97

12 mo 58.2 (10.8) 57.0 (10.1) 0.8 (�2.3 to 3.9) .62

a 95% CI�95% confidence interval.b NRS�numeric rating scale, scored from 0 (no pain) to 10 (worst pain).c n/a�not applicable.d PSFS�Patient-Specific Functional Scale, scored from 0 (unable to perform activity) to 10 (able to perform activity at preinjury level).e RMDQ-24�24-item Roland-Morris Disability Questionnaire, scored from 0 (no disability) to 24 (high disability).f GPE�Global Perceived Effect Scale, scored from �5 (vastly worse) to 5 (completely recovered).g Physical component score from the 36-Item Short-Form Health Survey questionnaire (SF-36) scored from 0 (low physical health) to 100 (high physicalhealth).h Mental component score from the SF-36 scored from 0 (low mental health) to 100 (high mental health).




Figure 2.Treatment outcomes at baseline and 2, 6, and 12 months after intervention. Values are unadjusted means and standard deviations.NRS�numeric rating scale, PSFS�Patient-Specific Functional Scale, RMDQ-24�24-item Roland-Morris Disability Questionnaire,GPE�Global Perceived Effect Scale, MCS�mental component score from the 36-Item Short-Form Health Survey questionnaire(SF-36), PCS�physical component score from the SF-36.




cally significant, or clinically impor-tant, differences between treatmentgroups for any of the outcomes atany of the time points (Tab. 4 andFig. 2). Adjusted treatment effectsfor the primary outcome of pain(0–10 visual analog scale) were 0.0(�0.7 to 0.8) at 2 months and 0.0(�0.8 to 0.8) at 6 months and forthe primary outcome of function

(0–10 PSFS) were 0.2 (�0.5 to 0.9)at 2 months and �0.2 (�0.9 to 0.5)at 6 months.

Twelve participants (14%) in thegraded activity group and 8 partici-pants (9%) in the motor controlexercise group experienced dur-able recovery. For this measure ofrecovery, the absolute risk reduction

was 5% (95% CI��5% to 15%) infavor of graded activity over motorcontrol exercises. Thirty-eight partic-ipants (44%) in the graded activitygroup and 35 participants (41%) inthe motor control exercise groupexperienced recovery according tothe more lax criterion. Therefore,the absolute risk reduction was 3%(95% CI��11% to 18%) in favor ofgraded activity over motor controlexercises.

The analysis of the monthly SMSpain measures using linear mixedmodels showed that there was nosignificant difference between the2 treatment groups in pain overthe previous 24 hours (effect esti-mate�0.9, 95% CI��0.5 to 0.7,P�.78) and pain over the previousweek (effect estimate�0.04, 95%CI��0.6 to 0.6, P�.91). Figure 3demonstrates the pain change overtime between groups. The meanAUC for pain over the previous24 hours was 42.4 (SD�22.6) inthe graded activity group and42.9 (SD�24.6) in the motor con-trol exercise group, with no significantdifference between treatment groups(t��.13, P�.9). The mean AUC forpain over the previous week was 43.0(SD�23.4) in the graded activitygroup and 43.7 (SD�24.0) in themotor control exercise group, with nosignificant difference between treat-ment groups (t��.17, P�.9).

DiscussionThis comparative effectiveness trialestablished that motor control exer-cises and graded activity have sim-ilar effects in reducing pain anddisability and increasing function,global impression of change, andquality of life in patients withchronic nonspecific low back painat short-term, intermediate-term, andlong-term follow-up. The estimatesof treatment effect were precise andexclude clinically important differ-ences. The rates of recurrence in thesubsequent 12 months and adverse

Figure 3.Monthly SMS pain outcomes in the 2 groups. Values are unadjusted means andstandard deviations. The upper panel illustrates pain over the previous 24 hours, andthe lower panel illustrates pain over the previous week.




effects with treatment also were sim-ilar in the 2 groups.

An important strength of this studywas that efforts were made to ensurethe optimal implementation of bothexercise interventions. The inter-ventions included supervised, indi-vidualized sessions and high doses ofexercise of approximately 20 hours.These characteristics have beenreported to be associated with betteroutcomes in trials of exercise thera-pies for patients with low backpain.22 In addition, experiencedtherapists received structured train-ing in the 2 interventions from thesame experts who trained therapistsin trials that found that both inter-ventions were effective in the treat-ment of patients with low backpain.27,31 Finally, this study wasdeveloped, registered, and publisheda priori with the design informed byexperts in the field who have pub-lished key literature on thistopic.11,33

The only previously published trialsimilar to the current trial, that ofCritchley et al,21 also showed no dif-ferences in outcome between motorcontrol exercises and graded activityat 6, 12, and 18 months after inter-vention. That study had a 3-groupdesign and included a motor controltreatment group, a graded activitytreatment group, and a treatmentgroup that received manual therapyplus home exercise. As the inter-ventions in the study by Critchleyet al were performed in a group,not individually, and more than 22%of the study participants were lostto follow-up, direct comparison withour results needs to be made withcaution. Despite the trial differences,the study by Critchley et al showedthat graded activity was more cost-effective than motor control exer-cise, as graded activity had slightlygreater effects and lower health carecosts. Our findings are in line withsystematic reviews of exercise ther-

apies that concluded there is no evi-dence to suggest one form of exer-cise therapy is better than anotherwhen applied to a nonspecific lowback pain group.4,5 These reviews,however, suggested that the qualityof exercise implementation may beimportant (eg, better results wereobserved in exercise programs thatwere individually designed and deliv-ered with supervision).22

Although the results of our study sug-gest that there is no differencebetween the 2 exercise therapies forpatients with chronic nonspecificlow back pain, these results do notpreclude the possibility that sub-groups of patients who respond bet-ter to each of these interventionsmay exist. Therefore, it is possiblethat patients with motor control def-icits at baseline, such as decreasedactivation of the transversus abdomi-nis muscle and decreased trunk pro-prioception, would benefit morefrom a motor control interventionand that patients with higher fear-avoidance, kinesiophobia, and lowerfitness levels would benefit morefrom a graded activity approach.Analyses to clarify this issue areongoing and form the basis of a sec-ondary analysis of our data, forwhich the sample size of this studywas calculated. Further informationon effect modifiers that are plausibleand yet to be tested are listed in ourpreviously published protocol.23

A limitation of this study was the factthat more participants were lost tofollow-up in one treatment groupthan the other (4 in the graded activ-ity group and 10 in the motor controlexercise group). Although no clearreasons for loss to follow-up wereidentified, we cannot exclude thepossibility that treatment may haveinfluenced the disparity in loss tofollow-up. However, due to thesmall overall loss to follow-up (lessthan the recommended 15%),50 webelieve it minimally affected the

results of this study. Another lim-itation of this study was the fact thatwe did not include a no-treatmentcontrol group that would allowthe evaluation of the “absolute”effects of both interventions. How-ever, previously published system-atic reviews of both interventionshave demonstrated that both areeffective: achieving better reduc-tions in pain and disability than notreatment or minimal intervention(eg, waiting list or general practitio-ner care).4,5 Finally, our trialincluded only self-reported measuresof function, and it may be that objec-tive measurement of function orphysical activity would have pro-vided a different result.

Given the results of this trial, we sug-gest that local factors should directclinician choice between the formsof exercise we tested. Both forms ofexercise are new developments inthe rehabilitation field, and so a cli-nician’s familiarity with either formwould be a prime consideration intreatment selection. The physicaltherapists who administered themotor control exercises in this trialhad access to real-time ultrasound toguide treatment selection and toassist the patient with learning theappropriate exercise. The limitedavailability of this equipment andlack of familiarity in using this spe-cific technology may be limitationsof this form of exercise, as not allphysical therapy clinics contain diag-nostic ultrasound machines. In ourstudy, one physical therapist chosenot to use the ultrasound machine,demonstrating the lack of familiarityof therapists with this technology,which has been proven to improvepatients’ outcomes.29

In conclusion, the results of this trialsuggest that motor control exercisesand graded activity have similareffects in reducing pain and disabil-ity and in increasing function, globalimpression of change, and quality of




life when applied to a nonspecificchronic low back pain group. Theseresults are similar to those of clini-cal guidelines that recommend thatno exercise therapy is superior toanother. We recommend that in clin-ical practice therapists identify theirarea of expertise and treat theirpatients accordingly.

Dr Macedo, Dr Latimer, Dr Maher, DrHodges, Dr Nicholas, and Mr Stafford pro-vided concept/idea/research design. DrMacedo, Dr Latimer, Dr Maher, Dr Hodges,Dr McAuley, and Dr Stanton provided writ-ing. Dr Macedo, Dr Hodges, Dr McAuley,Mr Stanton, Dr Stanton, and Mr Staffordprovided data collection. Dr Macedo, DrMaher, Dr Hodges, Dr McAuley, and MrStafford provided data analysis. Dr Macedo,Dr Latimer, Dr Maher, Dr Hodges, Dr McAu-ley, Mr Stanton, and Dr Stanton providedproject management. Dr Latimer, Dr Maher,and Dr Hodges provided fund procurement.Dr Latimer, Dr Hodges, and Ms Tonkinprovided institutional liaisons. Dr Macedoprovided clerical support. Dr Macedo, DrLatimer, Dr Maher, Dr Nicholas, Ms Tonkin,Mr Stanton, and Dr Stanton provided con-sultation (including review of manuscriptbefore submission).

The content of this article was presentedat the International Low Back Pain Forumfor Research in Primary Care, March 15–18, 2011, Melbourne, Victoria, Australia;the Annual Meeting of the InternationalSociety for the Study of the Lumbar Spine,June 14–18, 2011, Gothenburg, Sweden;and the Australian Physiotherapy AssociationConference, October 27–30, 2011, Bris-bane, Queensland, Australia.

The trial protocol was approved by theUniversity of Sydney (approval 12–2006/9704), the University of Queensland HumanResearch Ethics Committees (2007001583),and the Royal Brisbane and Women’s Hospi-tal Ethics Board (2007001583).

This trial received funding from Australia’sNational Health and Medical Research Coun-cil. Dr Latimer’s and Dr Maher’s researchfellowships are funded by the AustralianResearch Council. Dr Hodges’ research fel-lowship is funded by Australia’s NationalHealth and Medical Research Council.

Clinical trial registration: ACTRN12607-000432415.

DOI: 10.2522/ptj.20110290

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doi: 10.2522/ptj.20110290Originally published online December 1, 2011

2012; 92:363-377.PHYS THER. Stanton and Ryan StaffordNicholas, Lois Tonkin, Chris J. Stanton, Tasha R.Maher, Paul W. Hodges, James H. McAuley, Michael K. Luciana Gazzi Macedo, Jane Latimer, Christopher G.Back Pain: A Randomized Controlled TrialActivity in Patients With Chronic Nonspecific Low Effect of Motor Control Exercises Versus Graded

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Correction

April 2012 Volume 92 Number 4 Physical Therapy ■ 631

Macedo LG, Latimer J, Maher CG, et al. “Effect of motor control exercises versus graded activity in patients with chronic nonspecifi c low back pain: a randomized controlled trial.” Phys Ther. 2012;92:363–377.

An incorrect graph was used in Figure 3 of the article by Macedo et al. Figure 3 has been corrected in the online versions of this article. The corrected Figure 3 is shown below:

[DOI: 10.2522/ptj.20110290.cx]

Correction 4.12.indd 631Correction 4.12.indd 631 3/8/12 1:25 PM3/8/12 1:25 PM

phys ther 2012 macedo 363 77

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