Graded Activity and Graded Exposure for Persistent Nonspecific Low Back Pain: A Systematic Review

doi: 10.2522/ptj.20090303Originally published online April 15, 2010

2010; 90:860-879.PHYS THER. Maher, Jane Latimer and James H. McAuleyLuciana G. Macedo, Rob J.E.M. Smeets, Christopher G.Nonspecific Low Back Pain: A Systematic ReviewGraded Activity and Graded Exposure for Persistent

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Graded Activity and Graded Exposurefor Persistent NonspecificLow Back Pain: A Systematic ReviewLuciana G. Macedo, Rob J.E.M. Smeets, Christopher G. Maher, Jane Latimer,James H. McAuley

Background. Graded activity and graded exposure are increasingly being used inthe management of persistent low back pain; however, their effectiveness remainspoorly understood.

Purpose. The aim of this study was to systematically review randomized con-trolled trials that evaluated the effectiveness of graded activity or graded exposure forpersistent (�6 weeks in duration or recurrent) low back pain.

Data Sources. Trials were electronically searched and rated for quality by use ofthe PEDro scale (values of 0–10).

Study Selection. Randomized controlled trials of graded activity or gradedexposure that included pain, disability, global perceived effect, or work statusoutcomes were included in the study.

Data Extraction. Outcomes were converted to a scale from 0 to 100. Trials werepooled with software used for preparing and maintaining Cochrane reviews. Resultsare presented as weighted mean differences with 95% confidence intervals.

Data Synthesis. Fifteen trials with 1,654 patients were included. The trials hada median quality score of 6 (range�3–9). Pooled effects from 6 trials comparinggraded activity with a minimal intervention or no treatment favored graded activity,with 4 contrasts being statistically significant: mean values (95% confidence intervals)for pain in the short term, pain in the intermediate term, disability in the short term,and disability in the intermediate term were �6.2 (�9.4 to �3.0), �5.5 (�9.9 to�1.0), �6.5 (�10.1 to �3.0), and �3.9 (�7.4 to �0.4), respectively. None of thepooled effects from 6 trials comparing graded activity with another form of exercise,from 4 trials comparing graded activity with graded exposure, and from 2 trialscomparing graded exposure with a waiting list were statistically significant.

Limitations. Limitations of this review include the low quality of the studies,primarily those that evaluated graded exposure; the use of various types of outomemeasures; and differences in the implementation of the interventions, adding to theheterogeneity of the studies.

Conclusions. The available evidence suggests that graded activity in the shortterm and intermediate term is slightly more effective than a minimal intervention butnot more effective than other forms of exercise for persistent low back pain. Thelimited evidence suggests that graded exposure is as effective as minimal treatmentor graded activity for persistent low back pain.

L.G. Macedo, MSc, is a PhD can-didate at The George Institute forInternational Health, University ofSydney, PO Box M201, MissendenRd, Camperdown, New SouthWales 2050, Australia. Address allcorrespondence to Ms Macedo at:[email protected].

R.J.E.M. Smeets, MD, PhD, is Pro-fessor, Adelante Zorggroep, Hoens-broek, the Netherlands, andDepartment of Rehabilitation Med-icine, School of Public Health andPrimary Care, Maastricht University,Maastricht, the Netherlands.

C.G. Maher, PhD, is Director,Musculoskeletal Division, TheGeorge Institute for InternationalHealth, University of Sydney.

J. Latimer, PhD, is Associate Pro-fessor, The George Institute for In-ternational Health, University ofSydney.

J.H. McAuley, PhD, is ResearchManager, The George Institute forInternational Health, University ofSydney.

[Macedo LG, Smeets RJEM, MaherCG, et al. Graded activity andgraded exposure for persistentnonspecific low back pain: a sys-tematic review. Phys Ther. 2010;90:860–879.]

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Many patients with low backpain (LBP) have concernsthat are inadequately ex-

plained with a traditional biomedicalmodel. Contemporary approacheshave recognized the multifactorialetiology of LBP and the necessity toadopt a biopsychosocial modelwhen dealing with the condition.Cognitive behavioral models pro-pose that pain-related fear, kinesio-phobia, and unhelpful beliefs aboutback pain may be primary factorsleading to increased pain and a de-creased level of activity or function-ing.1,2 It has been suggested thatthese factors not only may representpsychosocial barriers to recovery butalso may contribute to important bi-ological changes, such as disuse anddeconditioning after an injury.3

Graded activity and graded exposureare interventions commonly used inthe management of persistent LBP.These treatments incorporate behav-ioral and cognitive approaches toimprove activity tolerance. The pri-mary difference between these inter-ventions is that, with graded expo-sure, patients are asked to create ahierarchy of feared activities. The ex-posure starts with the least fearedactivity, and the therapist helps thepatient appraise the exposure and itsconsequences and then address ir-rational and counterproductive be-liefs, leading to reductions in theanxiety associated with the activity.Once the negative associations are ex-tinguished, activities associated withhigher levels of anxiety are addressedin the same way. With graded activity,operant conditioning principles areused to reinforce healthy behaviors.The program focuses on functionalactivities and progresses in a time-contingent manner regardless ofpain to achieve functional goals andincreased activity. Principles of quo-tas, pacing, and self-reinforcementare key features of the program. Al-though both treatments have beenendorsed in clinical guidelines for

the management of persistent LBP,4,5

the effectiveness of the 2 treatmentshas not been well established.

Although no systematic review ofgraded activity or graded exposurehas been published, a Cochrane sys-tematic review of cognitive and be-havioral interventions for chronicLBP has been completed. The reviewconcluded that combined cognitivetherapy/respondent therapy and pro-gressive relaxation alone are effec-tive treatment modalities for short-term pain reduction in patients withchronic LBP but that there are nosignificant differences between thedifferent forms of behavioral inter-ventions.6 Because most of the stud-ies included in that review involvedonly psychological interventions,with minimal or no exercise compo-nent, the effectiveness of graded ac-tivity or graded exposure cannot beestablished from that review.

Therefore, the purpose of the presentstudy was to systematically review ran-domized controlled trials that evalu-ated the effectiveness of graded activ-ity and graded exposure interventionsfor the treatment of persistent (�6weeks in duration or recurrent) non-specific LBP at short-, intermediate-,and long-term follow-up evaluations.The outcomes of interest were pain,disability, global perceived effect, andreturn to work.

MethodData Sources and SearchesA computerized electronic search wasperformed to identify relevant arti-cles. The search was conducted onMEDLINE (1950 to February 2009),CINAHL (1982 to February 2009),PsychINFO (1806 to February 2009),PEDro (to February 2009), andEMBASE (1988 to February 2009). Keywords relating to the domains of ran-domized controlled trials and backpain were used, as recommended bythe Cochrane Back Review Group.7

Terms for graded activity and graded

exposure were included in the searchby use of MeSH (Medical Subject Head-ings of the National Library of Medi-cine) terms and specific guidelines foreach database (Appendix). Subjectsubheadings and word truncationsspecific for each database were used.There was no language restriction.

One reviewer screened the searchresults for potentially eligible stud-ies, and 2 reviewers independentlyreviewed the screened articles foreligibility. A third independent re-viewer resolved any disagreementabout the inclusion of trials. Authorswere contacted when more informa-tion about a trial was needed to al-low the inclusion of that trial. Manyauthors were contacted for addi-tional information related to inclusioncriteria.8–16 From the latter studies, weincluded 5 trials11,12,14–16 and ex-cluded 4 trials (2 authors confirmedthat their trials were not eligible,8,10

and we did not receive a responsefrom 2 authors). Staal et al16 pro-vided data for the subset of partici-pants who met the inclusion criteriafor this review (ie, excluding partic-ipants with acute pain).

Researchers who published relevantarticles were contacted to help iden-tify gray literature and articles inpress. Citation tracking was per-formed by use of the database Webof Science on ISI Web of Knowl-edge,* and a manual search of thereference lists of previous reviews

* Thomson Reuters, Level 3, 100 Harris St,Pyrmont, New South Wales 2009 Australia.

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Graded Activity and Graded Exposure for Low Back Pain

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and eligible trials also was per-formed. The International ClinicalTrials Registry platform from theWorld Health Organization and theCochrane Centre Register of Con-trolled Trials also were searchedwith terms for LBP, graded activity,and graded exposure.

Study SelectionStudies were eligible for inclusionwhen they were randomized con-trolled trials or quasi-randomizedcontrolled trials comparing gradedactivity or graded exposure to pla-cebo, no treatment, or another ac-tive treatment or when graded activ-ity or graded exposure was added asa supplement to other interventions.The reviewers followed a researchprotocol that was developed beforethe beginning of the review processand that included a checklist for in-clusion criteria.

Trials were considered to have eval-uated graded activity when the treat-ment included the following 3features:

• The treatment involved principlesof operant conditioning, such as re-inforcement of healthy behaviors.

• Treatment goals were functionalactivities.

• The program included a baselineand then incremented activities in atime-contingent manner regardlessof pain.

Additionally, trials in which treat-ments were described as graded ac-tivity and in which various hand-books2,17 were cited were deemedeligible.

Trials were considered to have eval-uated graded exposure when thetreatment included the following 4features:

• Feared activities were identified.• A hierarchy of feared activities was

created.• Exposure started with the least

feared activity.• The therapist assisted the patient in

appraising the exposure to fearedactivities and its consequences. Thetherapist addressed irrational be-

liefs, counterproductive beliefs, orboth.

Additionally, trials in which treat-ments were described as graded ex-posure and in which various hand-books18,19 were cited were deemedeligible.

Randomized or quasi-randomizedcontrolled trials were included whenthey explicitly reported that a crite-rion for entry was nonspecific LBP(with or without leg pain) with aduration of at least 6 weeks (non-acute LBP) or recurrent LBP. Therewas no age or sex restriction. Trialswere included when one of the fol-lowing outcome measures was re-ported: pain, disability, quality oflife, perceived effect, return to work,or recurrence.

Data Extraction andQuality AssessmentThe methodological quality of thetrials was assessed by use of thePEDro scale (values of 0–10), withscores extracted from the PEDrodatabase.20 Assessment of the qualityof trials in the PEDro database wasperformed by 2 trained independentraters, and disagreements were re-solved by a third rater. Methodolog-ical quality was not an inclusioncriterion.

Two independent reviewers ex-tracted data from the included stud-ies by using a standardized data ex-traction form. Mean scores, standarddeviations, and sample sizes were ex-tracted from the studies. When thisinformation was not provided in thetrial, the values were calculated orestimated by use of methods recom-mended in the Cochrane Handbookfor Systematic Reviews of Interven-tions.21 When there was insufficientinformation about outcomes to al-low data analysis, the authors of theincluded studies were contacted.All11,16,22–25 but one26 of the authors

The Bottom Line

What do we already know about this topic?

Graded activity and graded exposure differ from traditional exercisebecause these interventions incorporate psychological principles intoactivity prescription. It remains unclear whether either of these interven-tions is effective.

What new information does this study offer?

This review established that graded activity, but not graded exposure, isan effective treatment for persistent low back pain, although the effectsize is small. There is no evidence that either is superior to a traditionalexercise program for persistent low back pain.

If you’re a patient, what might these findings meanfor you?

Exercise is an effective treatment for persistent low back pain but thetype of exercise does not seem particularly important.




who were contacted to provide trialdata responded to our queries.

Means, standard deviations, and sam-ple sizes were extracted for short-term (less than 3 months after ran-domization), intermediate-term (atleast 3 months but less than 12months after randomization), andlong-term (12 months or more after

randomization) follow-up evalua-tions. When multiple time points fellwithin the same category, the onethat was closer to the end of treat-ment for the short term, closer to 6months for the intermediate term,and closer to 12 months for the longterm was used. These references fortime points were based on guide-lines from the Cochrane Back Re-

view Group.7 Scores for pain, disabil-ity, and global perceived effect wereconverted to a scale from 0 to 100.When more than 1 outcome measurewas used to assess pain, disability,and work status, the outcome mea-sure described as the primary out-come measure for the trial was in-cluded in this review.

Database searches : February 2009 PsychINFO: 183

CINAHL: 89 EMBASE: 2,161

MEDLINE: 1,545 PEDro: 868

Hand search: 4 Total after removing duplicates: 3,971

74 potentially eligible after assessing titlesand abstracts

Web of Science search 3 potentially eligible

15 original studies included in review (18 articles)

Reasons for exclusion:

33 did not use graded activity or graded exposure,8–10,28–57

6 included patients without nonspecific low back pain,58–63

3 included patients with acute low back pain,64–66 14 were not RCTs,67–80 8 were secondary analyses of another trial,81–88 and 1 used graded activity for both treatment groups89

83 potentially eligible

Indicated by experts 6 potentially eligible

Figure 1.Flow chart of systematic review inclusion and exclusion. RCTs�randomized controlled trials.




Data Synthesis and AnalysisResults were pooled when trialswere considered sufficiently homo-geneous with respect to participantcharacteristics, interventions, and out-comes. I2 was calculated by use ofRevMan 527 to assess statistical het-erogeneity. I2 describes the percent-age of the variability in effect estimatesthat is due to heterogeneity ratherthan sampling error (chance). A valuegreater than 50% may be consideredsubstantial heterogeneity.21 When tri-als were statistically homogeneous(I2�50%), pooled effects (weightedmean differences) were calculated byuse of a fixed-effects model. When tri-als were statistically heterogeneous(I2�50%), estimates of pooled effects(weighted mean differences) were ob-tained by use of a random-effectsmodel.21

ResultsStudy SelectionThe initial electronic database searchresulted in a total of 3,971 articlesafter the removal of duplicates. Ofthese, 74 articles were selected aspotentially eligible on the basis oftheir title and abstract. Through aWeb of Science search of these arti-cles, 3 other potentially eligible arti-cles were identified. A total of 77potentially eligible articles were con-sidered for inclusion; only 14 werefound to be eligible for inclusion inthis review (Fig. 1). Twenty-four ex-perts were contacted to provide in-formation about gray literature andarticles that we may have missed. Wereceived 12 responses suggesting 6potentially eligible studies; only 1 ofthese was included in this review.Therefore, we included a total of 15original studies with results pre-sented in 18 different articles.

The International Clinical Trials Reg-istry platform contained 8 random-ized controlled trials that were po-tentially eligible for inclusion. Ofthose, 3 were already included in ourstudy,22,26,90 3 were still recruiting

patients, and 2 were not eligible be-cause patients with acute back painwere included.

Methodological QualityThe methodological quality assess-ment with the PEDro scale revealed amedian score of 6 (range�3–9).Masking of the therapist was not in-cluded in any of the trials, as ex-pected in studies of activity prescrip-tion, and masking of patients wasincluded in only 1 trial.23 Point esti-mates and between-group compari-sons were present in 14 of 15 trials,12 of 15 trials had comparability atbaseline, and 10 of 15 trials had con-cealed allocation, intention to treat,and adequate follow-up evaluations.

Study CharacteristicsFourteen of the randomized con-trolled trials included in this reviewcompared graded activity or gradedexposure with another treatment orwith no treatment (Tabs. 1 and 2).One trial with a factorial design (2 �2) was also included; the first factorwas graded activity, the second fac-tor was advice, and each factor had 2levels (active versus sham).23

In 7 trials, graded activity was com-pared with a minimal intervention(usual care, waiting list, sham exer-cise, advice to stay active, or care by ageneral practitioner).12,16,22,23,26,86,92

In 6 trials, graded activity was com-pared with another form of exercise(motor control, high-intensity backschool, general physical therapy ex-ercises, active physical treatment, orphysical therapy according to guide-lines).11,14,15,22,25,26 In 4 trials, gradedactivity was compared with gradedexposure,12,90,91,94 and in 2 trials,graded exposure was comparedwith a waiting list.12,94

Graded Activity Versusa Minimal InterventionSeven trials with a total of 920 pa-tients compared graded activity witha minimal intervention.12,16,22,23,26,86,92

The methodological quality of thesetrials ranged from 4 to 9. Data forpooling were available for pain anddisability in the short, intermediate,and long terms and for perceived ef-fect in the short term. Data werepooled by use of a fixed-effectsmodel for all outcomes except painand disability in the long term andperceived effect in the short term,for which a random-effects modelwas used.

The pooled results favored gradedactivity for both pain and disability atshort- and medium-term follow-upevaluations, but the effects weresmall; for example, for pain in theshort term, the weighted mean dif-ference on a scale from 0 to 100was �6.2 points (95% confidence in-terval [CI]��9.4 to �3.0). For bothpain and disability at long-termfollow-up evaluations, the effectswere close to zero and not signifi-cant; for example, for pain the valuewas �0.1 (95% CI��10.4 to 10.2)(Fig. 2).

Results for return to work were pre-sented by 3 studies.26,92,95 The re-sults of 1 trial, that of Lindstrom etal,92 were expressed in likelihood ra-tios and showed that return to workwas faster for patients in the graded-activity group than for patients in thecontrol group. The median numberof days to return to work for thegraded-activity group was 35 days;that for the control group was 61days. Heymans et al26 used survivalanalysis to show that there were nosignificant differences between treat-ment groups at short-term follow-upevaluations (hazard ratio�1.0; 95%CI�0.8 to 1.4). The median numberof days of sick leave for the graded-activity group was 85; that for theusual-care group was 75. In contrast,the results of a survival analysisconducted by Streenstra et al95

showed a significantly earlier returnto work for the usual-care group(hazard ratio�0.52; 95% CI�0.32 to




Table 1.Details of Included Randomized Controlled Trials (RCTs)a

TrialParticipant Characteristics, Sample Size

(N), and Duration of ComplaintInterventions and

Study Design

Outcomes (Measures)and Time Points Included

in This ReviewPEDroScore

Critchley et al (2007)11 Recruited from referrals by specialist or primarycare practitioners to hospital’s physical therapydepartment

Age: �18 yMain exclusions: prior spinal surgery,

hematologic disease, and physical therapy inthe preceding 6 mo

N�143Duration: �12 wk

Graded activity vs motorcontrol vs manual therapy� home exercises (RCT)

Pain (VAS)Disability (RMDQ-24)Quality of life (EuroQol

Questionnaire)6- and 12-mo follow-up

evaluations

7

de Jong et al (2005)91 Referred for outpatient behavioral rehabilitationand reporting substantial fear of movement

Age: 18–65 yMain exclusions: pregnancy and

psychopathologyN�6Duration: �6 mo

Graded activity � educationvs graded exposure �education (crossoverstudy)

Disability (RMDQ-24)Crossover in short term only,

with 6- or 8-wk follow-upevaluations

3

Heymans et al (2006)26 Patients who visited their occupationalphysicians

Age: 18–65 yMain exclusions: specific pathologies,

pregnancy, and legal conflicts at workN�299Duration: �7 wk (at least 1 mo of pain and

3 wk of sick leave)

Graded activity (high-intensity back school) �usual care vs low-intensityback school (one thirdeducation, two thirdsexercise) � usual care vsusual care (RCT)

Pain (VAS)Disability (RMDQ-24)Global perceived effect (0–5)Sick leave (d) and return to

work (d)3- and 6-mo follow-up

evaluations

8

Leeuw et al (2008)90 Recruited by physicians and from advertisementsAge: 18–65 yMore than 3 points on the RMDQ-24More than 33 points on the Tampa Scale for

KinesiophobiaN�85Duration: �3 mo

Graded activity vs gradedexposure (RCT)

Pain (McGill VAS)Disability (QBPDS and PSFS)Posttreatment, 6-mo, and

12-mo follow-up evaluations

6

Lindstrom and colleagues(1992)92,93

Workers in industrial (“blue-collar”) jobs, on sickleave for 6 wk due to any low back paindiagnosis and not on sick leave for 12 wkbefore the current leave

Main exclusions: specific pathologies, surgery,and psychiatric diagnosis

N�103Duration: �8 wk of sick leave

Graded activity vs waitinglist (RCT)

Return to work (d), sick leave(d), and % of workersreturning to work

12-mo follow-up evaluations

5

Linton et al (2008)94 Recruited from primary care facilities andadvertisements in local newspaper

More than 35 points on the Tampa Scale forKinesiophobia

Age: 18–60 yN�46Duration: �3 mo

Graded exposure � usualcare vs waiting list �usual care (RCT)

Pain intensity (from Orebro)Disability (QBPDS)Posttreatment follow-up

evaluations

4

Nicholas et al (1991)15 Referred to a pain clinicAge: 20–60 yMain exclusion: no compensation claim within

12 moN�62Duration: �6 mo

Cognitive treatment vsbehavioral treatment(graded activity) vscognitive treatment �relaxation vs behavioraltreatment � relaxation vsattention controlcondition vs physicaltherapy only (RCT)

Pain rating chart5-wk, 6-mo, and 12-mo

follow-up evaluations

4

Nicholas et al (1992)14 Referred from a pain clinic and by specialist andgeneral medical practitioners

Age: 20–60 yMain exclusion: compensation claim due for

settlement within 12 moN�20Duration: �6 mo

Cognitive behavioraltreatment � physicaltherapy (graded activity)vs physical therapy �attention controlcondition (RCT)

Pain rating chart5-wk and 6-mo follow-up

evaluations

6

(Continued)




Table 1.Continued

TrialParticipant Characteristics, Sample Size

(N), and Duration of ComplaintInterventions and

Study Design

Outcomes (Measures)and Time Points Included

in This ReviewPEDroScore

Pengel et al (2007)23 Recruited by health care professionals and fromhospital waiting lists

Age: 18–80 yMain exclusions: spinal surgery, specific

pathologies, and contraindications to exerciseN�260Duration: �6 wk but �12 wk

Graded activity � advice vssham exercises � advicevs graded activity � shamadvice vs sham gradedactivity � sham exercises(RCT factorial design)

Pain (VAS)Disability (PSFS)Global perceived effect

(�5 to 5)6-wk, 4-mo, and 12-mo


9

Smeets et al (2006)22

Smeets et al (2008)24Recruited by general practitioners and medical

specialistsAge: 18–65 yMore than 3 points on the RMDQ-24Ability to walk at least 100 mMain exclusions: specific pathologies,

comorbidities, and clear treatment preferenceN�227Duration: �3 mo

Graded activity � problemsolving vs active physicaltreatment vs gradedactivity � problemsolving � active physicaltreatment vs waiting list(RCT)

Pain (McGill VAS)Disability (RMDQ-24)Global perceived effect

(1–7)10-wk, 6-mo, and 12-mo


8

Staal et al (2004)16

Hlobil et al (2005)98Workers employed by a major Dutch airlineMain exclusions: signs of nerve root compression

and cardiovascular problemsN�88Duration: �6 wk (for patients included in this

review)

Graded activity vs usual care(RCT)

Pain (VAS)Disability (RMDQ-24)Absence from work (d)3-mo, 6-mo, and 12-mo


8

Steenstra et al (2006)95

Anema et al (2007)96Recruited by occupational physiciansPatients in return-to-work program at 2–6 wk of

sick leaveAge: 18–65 yMain exclusions: specific low back pain,

cardiovascular and psychiatriccontraindications, pregnancy, and sick leavegranted for low back pain �1 mo

N�112Duration: �8 wk of sick leave

Graded activity vs usual care(advice to stay active �care by generalpractitioners) (RCT)

Pain (VAS)Disability (RMDQ-24)Sick leave (d) and return to

work (d)3-mo, 6-mo, and 12-mo


7

van der Roer et al (2008)25 Age: 18–65 yNew episode of nonspecific back painInability to resume daily activities in the last 3 wkN�114Duration: �12 wk

Graded activity vs guidelines(physical therapyaccording to clinicalguidelines) (RCT)

Pain (numerical rating scale)Disability (RMDQ-24)Global perceived effect

(0–6)6-wk, 6-mo, and 12-mo


7

Vlaeyen et al (2002)97 Referred for outpatient behavioral rehabilitationand reporting substantial fear of movement

Age: 18–65 yMain exclusions: pregnancy and

psychopathologyN�6Duration: �6 mo

Graded activity vs gradedexposure (crossoverstudy)

Pain (VAS)Disability (RMDQ-24)Crossover with 12-wk and 12-

mo follow-up evaluations

4

Woods and Asmundson (2008)12 Recruited from newspapers, e-mailadvertisements, and posters

Age: 19–65 yMore than 38 points on the Tampa Scale for

KinesiophobiaMain exclusions: pending medical investigations

and back surgeryN�83Duration: �6 mo

Graded activity vs gradedexposure vs waiting list(RCT)

Pain Disability IndexMcGill Pain Questionnaire

(short form)4-wk follow-up evaluations

5

a VAS�visual analog scale, RMDQ-24�24-Item Roland-Morris Disability Questionnaire, QBPDS�Quebec Back Pain Disability Scale, PSFS�Patient-Specific FunctionalScale, Orebro�Orebro Musculoskeletal Pain Questionnaire.




Table 2.Details of Graded-Activity (GA) and Graded-Exposure (GE) Interventions

Study

Duration ofGA and

GE Interventions

Expertise of theCaregiver and

Integrity Check Home Program

Plans forFutureRelapse Adherence

Critchley et al (2007)11 Maximum of 9 sessionsof 90 min

Physical therapists whohad at least 2 y ofclinical experienceand who agreed totreat according tothe trial protocolwere provided brieftraining. Thehospitals had theirown commoninternal teachingprogram for theleaders of thegraded-activityprogram; otherwise,there was no furthertraining. Adherenceto the protocol wasassessed by recordingtreatments fromphysical therapynotes after treatmentallocation wasrevealed.

Not stated Not stated Participants reported difficultyattending classes twice/wk

de Jong et al (2005)91 Graded activity for32 h over 8 wk andgraded exposure for24 h over 6 wk

Not stated Not stated Not stated Not stated

Heymans et al (2006)26 16 sessions of 1 h over8 wk

Supervised physicaltherapist

Home exercises were givenduring the treatmentperiod

Not stated Patients attended an averageof 13 sessions; 70% ofworkers completed alltreatments, and 10%received no treatment

Leeuw et al (2008)90 Graded activity in 26sessions of 1-htreatments startingtwice/wk and gradedexposure in 16sessions of 1-htreatments startingtwice/wk

Physical therapists withat least 6 mo ofexperience weretrained in bothtreatments andreceived a manualwith guidelines fordealing withproblems. Therapistsattended collectivesupervision sessions 3times/y. Asophisticated methodfor judgingadherence totreatment andcontamination wasused. Thirty randomsamples from 265recorded sessionswere judged.

Most practice of exercisesoccurred at home, andprogress was evaluatedat sessions; homeexercises were givenonly for the graded-activity group

Not stated 29% of patients receivinggraded exposure and 33%of patients receiving gradedactivity did not finish thetreatments

Lindstrom et al (1992)92 3 d/wk until return towork

Physical therapist No home exercises Not stated Not stated

Linton et al (2008)94 13–15 individualsessions of behavioraltherapy and 8–10sessions of exposurein vivo

Therapy was performedby psychologists whowere trained byVlaeyen et al97 andalso received supportfrom a physicaltherapist. A writtentreatment manualwas developed forthe study.

Sessions ended with homeassignment thatincorporatedmovements intoactivities of daily living athome and work

Not stated Not stated

(Continued)




Table 2.Continued

Study

Duration ofGA and

GE Interventions




Nicholas et al (1991)15 One 2-h session andone 1.5-h session/wkfor 5 wk (only 5sessions werecognitive behavioraltherapy)

Therapy was performed bya clinical psychologistwith 5 y of experienceand registered physicaltherapists under thesupervision of a seniorphysical therapist. Twomasked ratersindependently andcorrectly identified 6audiotapes randomlyselected from cognitivebehavioral, behavioral,and attention controlconditions, providingevidence that thecontent of eachcondition was consistentwith the treatmentprotocol.

Patients were verballypraised by thepsychologist forpracticing physicaltherapy exercises eachweek


Nicholas et al (1992)14 One 2-h session andone 1.5-h session/wkfor 5 wk

One hour of the firstsession each week wasconducted by a physicaltherapist, and the otherhour was conducted bya psychologist who had5 y of experience sincecompleting clinicalqualifications. A physicaltherapist under thesupervision of a seniorphysical therapistconducted the secondsession each week.

Patients were encouragedby physical therapists topractice exercises athome, but no check onthe practice was madeand no specificreinforcement forperforming exercises wasprovided by physicaltherapists


Pengel et al (2007)23 12 sessions over 6 wk:3 times/wk in weeks1 and 2, twice/wk inweeks 3 and 4, andonce/wk in weeks 5and 6; participantsalso attended 3sessions of advice

Registered physicaltherapists receivedtraining from anexperienced clinicalpsychologist. Aninvestigator recordedand assessed a sampletreatment session andvisited each treatmentsite regularly to monitordelivery.

Individualized hometreatment was regularlyreviewed, and patientswere encouraged tocontinue after the end ofthe treatment period

Not stated Means of 9.4 (SD�3.2)sessions of exercises and 2.9(SD�1.1) sessions of advice

Smeets et al (2006)22

Smeets et al (2008)2418 sessions over 10 wk,

changing from3 sessions/wk to1 session/wk, for atotal of 11.5 h oftreatment

All therapists receivedextensive training beforethe start of the trialand refresher courses.Social workers andpsychologists had atleast 5 y of experience.

Home assignment wasgiven to allow patientsto practice skills in theirdaily lives

Not stated Means of 14.3 sessions(maximum�20) for thecognitive behavioral therapygroup and 11.9 sessions(maximum�19) for thecombination group

Staal et al (2004)16

Hlobil et al (2005)981-h exercise session

twice/wk until returnto work or amaximum of 3 mo

Three therapists providedtreatment according toa protocol. Therapistswere trained before thestudy in three 2-hsessions and practicedpatient-therapistinteractions. Sessionsbefore and after thestudy were audiotapedand analyzed forcontent.

Not stated Not stated Not stated

(Continued)




0.86). The median number of days toreturn to work was 139 days for thegraded-activity group and 111 daysfor the usual-care group.

Graded Activity VersusOther Forms of ExerciseSix trials (597 patients) with a meth-odological quality ranging from 4 to8 compared graded activity withother forms of exercise.11,14,15,22,25,26

Data for pooling were available forpain, disability, and perceived effectin the short, intermediate, and longterm. Data were pooled by use of afixed-effects model for all outcomesexcept perceived effect in the short

and intermediate term, for which arandom-effects model was used.Pooled results revealed no statisti-cally significant differences betweengraded activity and other forms ofexercise for pain, disability, or globalperceived effect at each time point(Fig. 3).

A hazard ratio for the difference indays to return to work was calcu-lated by Heymans et al26; the resultsrevealed no significant differencesbetween treatment groups (hazardratio�1.4; 95% CI�1.0 to 1.9). Themedian number of days of sick leavewas 85 days for the graded-activity

group and 68 days for the exercisegroup.

Graded Exposure VersusGraded ActivityTwo low-quality trials (PEDro scoresof 3 and 4), with 6 patients each,compared graded activity withgraded exposure.91,97 Both studieshad a crossover design, making itmore difficult to reach any conclu-sion about the results because noevaluation of carryover effects wasperformed. Another 2 studies12,90

had information that allowed pool-ing for pain and disability in the shortterm. These 2 trials had PEDro scores

Table 2.Continued

Study

Duration ofGA and

GE Interventions




Steenstra et al (2006)95

Anema et al (2007)9626 sessions of 1 h

(twice/wk) over13 wk or until returnto work

Physical therapists(47 in 16 centers)were trained by thephysical therapistparticipating in thestudy of Staal et al.77

A protocol was usedto standardize theintervention. Physicaltherapists had a 2-hfeedback sessionevery 3 mo.

Not stated Not stated 35% of patients did notadhere to the treatment;average frequency was 14.1sessions

van der Roer et al(2008)25

10 individual sessionsand 20 groupsessions

Physical therapistsattended 2 intensive6-h workshops andwere trainedaccording to thestudy protocol. Studyforms were used toassess therapistadherence to thestudy protocol; 18%of patients did notreceive adequatetreatment.


Vlaeyen et al (2002)97 3 wk of treatment Not stated Patients were given 1 wkto practice new skills inhome situations after theend of the 3-wktreatment


Woods and Asmundson(2008)12

Eight 45-min sessionsconducted on twice-weekly basis over4 wk

Graded activity wasconducted by aregistered physicaltherapist, and gradedexposure wasconducted by aclinical psychologistgraduate studenttrained in thetherapy andsupervised by aregistered doctoral-level psychologist.





Figure 2.Forest plot of results of randomized controlled trials comparing graded activity with a control (minimal intervention). Values representeffect sizes (weighted mean differences) and 95% confidence intervals. The pooled effect sizes were calculated by use of afixed-effects model for all outcomes except pain and disability in the long term and perceived effect in the short term, for which arandom-effects model was used.




Figure 3.Forest plot of results of randomized controlled trials comparing graded activity with other forms of exercise. Values represent effectsizes (weighted mean differences) and 95% confidence intervals. The pooled effect sizes were calculated by use of a fixed-effectsmodel for all outcomes except perceived effect in the short and intermediate term, for which a random-effects model was used.




of 5 and 6 and included 146 patients.The results of the pooled analysisrevealed no statistically significantdifferences between treatmentgroups for pain and disability in theshort term (Fig. 4).

Graded Exposure Versus aMinimal InterventionTwo trials (104 patients) (PEDroscores of 4 and 5) compared gradedexposure with a minimal interven-tion (waiting list or usual care).12,94

Data for pooling were available forpain and disability in the short term.Pooled results revealed no statisti-cally significant differences betweentreatment groups for pain in theshort term (weighted mean differ-

ence on a scale of 0–100��3.7points [95% CI��12.3 to 4.9]) anddisability in the short term (weightedmean difference on a scale of0–100��3.5 points [95% CI��19.4 to 12.3]) (Fig. 5). No datawere available for quality of life orrecurrence for any of thecomparisons.

DiscussionIn this systematic review, we com-pared the effects of graded activityversus a minimal intervention,graded activity versus other forms ofexercise, graded activity versusgraded exposure, and graded expo-sure versus a minimal interventionfor patients with persistent LBP.

Only 4 of the pooled effect sizeswere statistically significant. Thesestatistically significant results favoredgraded activity over a minimal inter-vention for pain and disability atshort- and intermediate-term follow-upevaluations. However, the effectsizes were small, approximately 7points on a 100-point scale; this find-ing may indicate that they are notclinically meaningful.

Among the studies in which gradedactivity was compared with a mini-mal intervention, 2 trials had coun-terintuitive results: The minimal in-tervention provided better outcomesthan graded activity.12,95 The studyof Woods and Asmundson12 poten-

Figure 4.Forest plot of results of randomized controlled trials comparing graded activity with graded exposure. Values represent effect sizes(weighted mean differences) and 95% confidence intervals. The pooled effect sizes were calculated by use of a fixed-effects model.

Figure 5.Forest plot of results of randomized controlled trials comparing graded exposure with a control (waiting list or usual care). Valuesrepresent effect sizes (weighted mean differences) and 95% confidence intervals. The pooled effect sizes were calculated by use ofa fixed-effects model for pain and a random-effects model for disability.




tially provided biased estimates oftreatment effects because of a lack ofmasking, failure to conceal alloca-tion, and a loss to follow-up of ap-proximately 50%. In contrast, thestudy of Steenstra et al95 seemed tobe well conducted, and we are un-able to explain why the results forpain and disability in the long termfavored a minimal intervention overgraded activity.

The results of the 3 trials that mea-sured return to work after gradedactivity versus a minimal interven-tion were conflicting. In 1 of these 3trials,92 graded activity provided afaster return to work than a minimalintervention. In the second trial,26

there were no significant differencesbetween treatment groups. In thethird study,95 a minimal interventionprovided a faster return to work thangraded activity. The authors of thelast study suggested that the longerdelay in return to work for patientsin the graded-activity group was at-tributable to a delay in the beginningof the treatment for this group. De-spite the possible bias present inthese studies, the results regardingreturn to work are inconclusive, andfurther research is needed.

The results for comparisons ofgraded activity with other forms ofexercise are in accordance with therecommendations of most clinicalguidelines, which suggest that noform of exercise is more effectivethan another.99 However, Smeets etal84 did find that graded activity wasmore cost-effective than active phys-ical treatment (exercises), drawingattention to the need for more cost-effectiveness studies.

In many cases, the interventionswere implemented by trained physi-cal therapists. Although adherenceto the treatment protocols was as-sessed in 6 of the 15 studies, no re-sults of this assessment were pro-vided; therefore, it remains unclear

whether the interventions wereproperly administered. Additionally,it is uncertain whether 2 or 3 ses-sions of training provided the clini-cians with sufficient skills to effec-tively implement the treatmentprotocols. There is some evidencethat trained physical therapists lackthe skills required to effectively im-plement a psychologically basedintervention.100

One important feature of both treat-ments considered in this review isinclusion of a plan for managing re-lapses. This strategy not only helpspatients deal with anxiety and fearabout a flare-up but also may assist inmaintaining the long-term effects ofthe intervention. Although none ofthe studies mentioned the use of thisstrategy, it is not clear whether itwas omitted from the intervention orsimply was not reported.

There are some limitations to theconclusions of this review. These in-clude the low quality of the studies,primarily those evaluating graded ex-posure, the use of various types ofoutcomes, and differences in the im-plementation of the interventions.The small number of trials testinggraded exposure is also an importantlimitation of this review. Some au-thors92,97 suggested that graded ex-posure may have larger effects thangraded activity because the formerintervention more specifically tar-gets a patient’s fears; however, thesmall number of trials included inthis review for this comparison doesnot allow a reliable conclusion to bedrawn. Future research should focuson the conduct of higher-quality trialsevaluating issues such as return towork and compensation and the con-duct of cost-effectiveness studies. Ad-ditionally, trials including patientsidentified as having greater fear behav-iors should be carried out becausethese patients may respond better toboth graded activity and graded expo-sure interventions.97

ConclusionThe results of this systematic reviewsuggest that graded activity is slightlymore effective than a minimal inter-vention but not more effective thanother forms of exercise for pain, dis-ability, and global perceived effect inthe short and intermediate terms forpatients with persistent nonspecificLBP. The results also suggest thatgraded exposure is no more effectivethan a minimal intervention orgraded activity. Because of the poorreporting in many of the studies, itoften was unclear precisely how theinterventions were implemented.Additionally, the smaller number andlower quality of graded-exposure tri-als limits the conclusions that can bedrawn regarding this intervention.

Ms Macedo, Dr Smeets, Dr Maher, and DrLatimer provided concept/idea/research de-sign. All authors provided writing and datacollection. Ms Macedo and Dr Smeets pro-vided data analysis. Ms Macedo providedproject management. Dr Smeets, Dr Maher,and Dr Latimer provided facilities/equipment.Dr Smeets provided institutional liaisons. DrSmeets, Dr Maher, Dr Latimer, and DrMcAuley provided consultation (includingreview of manuscript before submission).The authors of this systematic review thankthe authors of the retrieved trials who pro-vided additional information or data fromtheir trials.

Ms Macedo holds a PhD scholarship jointlyfunded by the University of Sydney and theAustralian Government. Dr Maher’s researchfellowship is funded by Australia’s NationalHealth and Medical Research Council, andDr Latimer’s research fellowship is funded bythe Australian Research Council.

The results of this study were presented atthe Australian Physiotherapy AssociationConference; October 1–5, 2009; Sydney,Australia.

This article was submitted September 14,2009, and was accepted January 24, 2010.

DOI: 10.2522/ptj.20090303




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Appendix.Search Strategies

MEDLINE1. randomized controlled trial/2. controlled clinical trial/3. randomized controlled trials.mp.4. random allocation/5. random allocation.mp.6. double-blind method/7. single-blind method/8. exp clinical trial/9. (clinic$ adj25 trial$).tw.10. ((single$ or double$ or treble$ or triple$) adj (mask$ or blind$)).tw.11. placebos/12. placebo$.tw.13. random$.tw.14. research design/15. (latin adj square).tw.16. comparative study/17. exp evaluation studies/18. follow-up studies/19. (control$ or prospective$ or volunteer$).tw.20. cross-over studies/21. or/1–2022. animal/not human/23. 21 not 2224. low back pain/25. low back pain.mp.26. backache.mp.27. lumbago.mp.28. sciatica/29. sciatica.mp.30. back pain/31. or/24–3032. 23 and 3133. graded activity.mp.34. graded exposure.mp.35. behavioral therapy.mp.36. behavior therapy/37. cognitive therapy/38. psychology/39. cognitive.mp.40. gradual exercises.mp.41. function.mp.42. physical therapy modalities/43. or/33–4244. 32 and 43

PsychINFO1. randomized controlled trial$.mp2. random allocation.mp.3. exp clinical trials/4. (clinic$ adj25 trial$).tw.5. ((single$ or double$ or treble$ or triple$) adj (mask$ or blind$)).tw.

(Continued)




Appendix.Continued

6. placebo$.tw.7. random$.tw.8. research design/9. (latin adj square).tw.10. (control$ or prospective$ or volunteer$).tw.11. or/1–1012. low back pain.mp13. backache.mp14. lumbago.mp15. sciatica.mp16. back pain/17. or/12–1618. graded activity.mp19. graded exposure.mp20. behavioral therapy.mp21. behavior therapy/22. cognitive therapy/23. cognitive.mp.24. psychology/25. function.mp26. or/18–2527. 11 and 17 and 26

EMBASE1. randomized controlled trial/2. exp controlled clinical trial/3. randomized controlled trial$.mp4. exp randomization/5. random allocation.mp.6. double-blind procedure/7. single-blind procedure/8. clinical trial/9. (clinic$ adj25 trial$).tw.10. ((single$ or double$ or treble$ or triple$) adj (mask$ or blind$)).tw.11. exp placebo/12. placebo$.mp.13. random$.mp14. research design.mp15. exp comparative study/16. exp evaluation/17. exp follow-up/18. (control$ or prospective$ or volunteer$).tw.19. crossover procedure/20. or/1–1921. animal/not human/22. 20 not 2123. exp low back pain/24. low back pain.mp25. exp backache/26. lumbago.mp27. sciatica.mp28. or/23–27

(Continued)




Appendix.Continued

29. graded activity.mp30. graded exposure.mp31. behavioral therapy.mp32. exp behavior therapy/33. exp cognitive therapy/34. cognitive.mp.35. exp psychology/36. gradual exercises.mp.37. function.mp38. physical therapy modalities.mp39. or/29–3840. 22 and 28 and 39

CINAHLS1. (MH clinical trials�) or (MH Cochrane Library) or (MH random assignment)S2. (double blind) or (MH double-blind studies) or (MH single-blind studies) or (MH triple-blind studies)S3. (placebo) or (MH placebos)S4. randomized controlled trialS5. (MH crossover design) or (MH experimental studies�)S6. (MH comparative studies) or (MH experimental studies�)S7. S1 or S2 or S3 or S4 or S5 or S6S8. (MH low back pain) or (MH back pain�)S9. (backache) or (MH back pain�)S10. low back painS11. lumbagoS12. (sciatica) or (MH sciatica)S13. S8 or S9 or S10 or S11 or S12S14. graded activityS15. graded exposureS16. (behavioral therapy) or (MH behavior therapy�)S17. (cognitive therapy) or (MH cognitive therapy) or (MH cognitive therapy (Iowa NIC) (non-CINAHL)�)S18. (cognitive) or (MH rehabilitation, cognitive)S19. (MH rehabilitation, psychosocial�)S20. S14 or S15 or S16 or S17 or S18 or S19S21. S7 and S13 and S20

PEDroTherapy: No selectionProblem: painBody Part: lumbar spine, sacro-iliac joint or pelvisSubdiscipline: No selectionMethod: clinical trial




doi: 10.2522/ptj.20090303Originally published online April 15, 2010

2010; 90:860-879.PHYS THER. Maher, Jane Latimer and James H. McAuleyLuciana G. Macedo, Rob J.E.M. Smeets, Christopher G.Nonspecific Low Back Pain: A Systematic ReviewGraded Activity and Graded Exposure for Persistent

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Graded Activity and Graded Exposure for Persistent Nonspecific Low Back Pain: A Systematic Review