Early Identification and Management of Psychological Risk Factors (Yellow Flags) in Patients With...

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doi: 10.2522/ptj.20100224 Published online March 30, 2011 PHYS THER. and Chris J. Main Michael K. Nicholas, Steven J. Linton, Paul J. Watson Patients With Low Back Pain: A Reappraisal Psychological Risk Factors (''Yellow Flags'') in Early Identification and Management of http://ptjournal.apta.org/content/early/2011/03/29/ptj.20100224 found online at: The online version of this article, along with updated information and services, can be Collections Work and Community Reintegration Psychosocial: Other Pain Injuries and Conditions: Low Back Fear-Avoidance Diagnosis/Prognosis: Other Clinical Decision Making in the following collection(s): This article, along with others on similar topics, appears E-mail alerts to receive free e-mail alerts here Sign up corrections and replace the original author manuscript. : edited and typeset versions of articles that incorporate any author Page proofs readers almost immediate access to accepted papers. PTJ accepted for publication but have not yet been copyedited or typeset. This allows : PDF versions of manuscripts that have been peer-reviewed and Author manuscripts publishes 2 types of Online First articles: PTJ ). PTJ ( Physical Therapy Online First articles are published online before they appear in a regular issue of by guest on March 9, 2013 http://ptjournal.apta.org/ Downloaded from

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doi: 10.2522/ptj.20100224 Published online March 30, 2011PHYS THER. 

and Chris J. MainMichael K. Nicholas, Steven J. Linton, Paul J. WatsonPatients With Low Back Pain: A ReappraisalPsychological Risk Factors (''Yellow Flags'') in Early Identification and Management of

http://ptjournal.apta.org/content/early/2011/03/29/ptj.20100224found online at: The online version of this article, along with updated information and services, can be

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Work and Community Reintegration     Psychosocial: Other    

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corrections and replace the original author manuscript. : edited and typeset versions of articles that incorporate any authorPage proofs

  readers almost immediate access to accepted papers.

PTJaccepted for publication but have not yet been copyedited or typeset. This allows : PDF versions of manuscripts that have been peer-reviewed andAuthor manuscripts

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Early Identification and Managementof Psychological Risk Factors(“Yellow Flags”) in PatientsWith Low Back Pain: A ReappraisalMichael K. Nicholas, Steven J. Linton, Paul J. Watson, Chris J. Main,the “Decade of the Flags” Working Group

Originally the term “yellow flags” was used to describe psychosocial prognosticfactors for the development of disability following the onset of musculoskeletal pain.The identification of yellow flags through early screening was expected to promptthe application of intervention guidelines to achieve secondary prevention. In recentconceptualizations of yellow flags, it has been suggested that their range of applica-bility should be confined primarily to psychological risk factors to differentiate themfrom other risk factors, such as social and environmental variables. This articleaddresses 2 specific questions that arise from this development: (1) Can yellow flagsinfluence outcomes in people with acute or subacute low back pain? and (2) Canyellow flags be targeted in interventions to produce better outcomes? Consistentevidence has been found to support the role of various psychological factors inprognosis, although questions remain about which factors are the most important,both individually and in combination, and how they affect outcomes. Published earlyinterventions have reported mixed results, but, overall, the evidence suggests thattargeting yellow flags, particularly when they are at high levels, does seem to lead tomore consistently positive results than either ignoring them or providing omnibusinterventions to people regardless of psychological risk factors. Psychological riskfactors for poor prognosis can be identified clinically and addressed within interven-tions, but questions remain in relation to issues such as timing, necessary skills,content of treatments, and context. In addition, there is still a need to elucidatemechanisms of change and better integrate this understanding into the broadercontext of secondary prevention of chronic pain and disability.

M.K. Nicholas, PhD, is AssociateProfessor, Pain ManagementResearch Institute, University ofSydney at Royal North Shore Hos-pital, St Leonards, New SouthWales, Australia.

S.J. Linton, PhD, is Professor andResearch Director, Centre ofHealth and Medical Psychology,Orebro University, Sweden.

P.J. Watson, PhD, is Professor ofPain Management and Rehabilita-tion, Department of Health Sci-ences, University of Leicester,Leicester, United Kingdom.

C.J. Main, PhD, FBPsS, is Professorof Clinical Psychology (Pain Man-agement), Arthritis Research UKPrimary Care Centre, Keele Univer-sity, Keele, Staffordshire, UnitedKingdom. Mailing address: Calder-bank Research Unit, 87 Palatine Rd,West Didsbury, Manchester M203JQ, United Kingdom. Address allcorrespondence to Professor Mainat: [email protected].

“Decade of the Flags” WorkingGroup (see list of other membersin the Footnotes section).

[Nicholas MK, Linton SJ, WatsonPJ, Main CJ, the “Decade of theFlags” Working Group. Early iden-tification and management of psy-chological risk factors (“yellowflags”) in patients with low backpain: a reappraisal. Phys Ther.2011;91:xxx–xxx.]

© 2011 American Physical TherapyAssociation

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Kendall and colleagues1 coinedthe term “yellow flags” toencompass psychological risk

factors and social and environmentalrisk factors for prolonged disabilityand failure to return to work as a con-sequence of musculoskeletal symp-toms. The concept of yellow flagssparked much attention and debateand was adopted in some guidelineson the early management of work-related low back injuries.2–4 However,as with many such guidelines, theirimpact on clinical practice is unclear.5

Even the definition of psychosocialrisk factors has been criticized as sobroad as to be meaningless.6

Kendall and colleagues1 identified anumber of psychological risk fac-tors and social and environmentalrisk factors for disability and workloss. These psychological risk factorsincluded fears about pain or injury,unhelpful beliefs about recovery,and distressed affect (eg, despon-dency and anxiety). The social andenvironmental risk factors includedworkers’ perceptions that the work-place is unsupportive and overlysupportive health care providers.The monograph provided a guideto the assessment of yellow flags thatincluded a clinical interview and apsychosocial screening questionnaire.This approach assumed that individ-uals at risk for poor outcomes couldbe identified on the basis of eithera small cluster of highly salient fac-tors or the cumulative combinationof several factors. Because many ofthese factors are potentially modifi-able, the monograph also containedadditional advice on how to incor-porate cognitive-behavioral changeprinciples into early management.

In recent years, the focus of researchon yellow flags has been more spe-cifically applied to occupationalcontexts. Main and Burton7 haveargued that, in these contexts, theterm “yellow flags” should bereserved for more overtly psycholog-

ical risk factors, such as fears andunhelpful beliefs, whereas the social/environmental (workplace) risk fac-tors could be divided into 2 catego-ries: (1) workers’ perceptions thattheir workplace is stressful, unsup-portive, and excessively demanding,which they termed “blue flags,” and(2) the more observable characteris-tics of the workplace and nature ofthe work, as well the insurance andcompensation system under whichworkplace injuries are managed,which they termed “black flags.”More recently, a distinction has beendrawn between psychological riskfactors that might be consideredessentially “normal,” but unhelpful,psychological reactions to musculo-skeletal symptoms (eg, the beliefthat pain necessarily implies dam-age) and clearly “abnormal” psycho-logical or psychiatric factors or dis-orders (eg, posttraumatic stressdisorder, major depression) sugges-tive of diagnosable psychopathol-ogy.8,9 It has been suggested that thenormal but unhelpful psychologicalreactions should be described asyellow flags, and those meeting cri-teria for psychopathology should betermed “orange flags.”8,9 The pri-mary significance of this distinctionis to differentiate yellow flag factors,which might be amenable to changeby suitably trained health care pro-viders such as general medical prac-titioners and physical therapists,from orange flag factors that proba-bly require specialist mental healthreferral. A brief summary of the dif-ferent flags is presented in Table 1.

Given these developments in theflags concept and the length of timethey have been in circulation, itseemed timely to reappraise the util-ity of yellow flags: first, as risk factorsfor the development of persistentpain and associated disability, andsecond, in terms of their value in theidentification of “at-risk” cases fortargeted intervention. Our appraisalwas formulated in terms of 2 research

questions: (1) Can yellow flags influ-ence outcomes in people with acuteor subacute low back pain (LBP)? and(2) Can interventions that target yel-low flags achieve better outcomes?

Search StrategyIn our search for risk factors, wecanvassed the literature in MEDLINEand PsycINFO for review articlespublished between 2000 and 2009.Our aim was to provide a representa-tive picture of the existing literaturerather than to provide an exhaustivesystematic or methodological review.More specifically, the literature searchfocused first on a combination ofpain syndromes such as back painor neck pain and then on a com-bination of psychological factorssuch as yellow flags or psycholog-ical factors. These 2 searches thenwere amalgamated, producing 1,241citations (the search strategy isdetailed in the Figure). These cita-tions were scrutinized for inclusion,and 244 were selected for closerevaluation because they were sys-tematic reviews (45), another formof review (84), randomized con-trolled trials (RCTs) (32), or clinicaltrials (83). These articles were exam-ined according to the inclusion cri-teria, and 28 relevant reviews wereidentified. Of these 28 reviews, 13 (5systematic, 8 critical) were includedin our examination, as the otherseither did not pertain to musculo-skeletal pain or did not specificallyreview the role of psychologicalyellow flags.

In our examination of the potentialuse of flags in identifying patients atrisk for acute or subacute pain (ques-tion 1), we identified and appraisedthe instruments used to identify yel-low flags in published LBP studies(mainly in cohort studies and RCTs).We also were assisted by the evalua-tion of measurement instrumentsoffered in 2 reviews.10,11 It trans-pired, in fact, that very few instru-ments have been used specifically

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for case identification. The studiesthat met these criteria are summa-rized in Table 2.

Evidence on the use of flags in thecontext of interventions (question2), was identified from a search ofdatabases (MEDLINE and PsycINFO),examination of reference lists, andconsultation among the authors.Search terms used were “English lan-guage,” “low back pain,” “backpain,” “musculoskeletal,” “psychoso-cial risk factors,” “early intervention,”“secondary prevention,” “disabilityprevention,” “rehabilitation,” “occupa-tional health,” and “controlled trials.”

Although the search was notintended to be exhaustive andmethodological assessments werenot conducted, the studies wereselected on the basis that they metthe criteria of being published inpeer-reviewed journals and wereRCTs; used people with mostly backpain that had persisted or causedclear disability (eg, work time lost)for mostly less than 6 months (ie,generally within the acute and sub-acute range); and reported on func-tional outcomes, especially return towork or reduced disability. It shouldbe noted that in the interest of cap-turing enough material for a mean-ingful analysis, studies were notrestricted to individuals with onlyLBP. Many studies included mostlypeople with LBP, but many alsoincluded people with pain in othersites, such as the leg and upper back.As we were interested in investigat-ing the role of psychological vari-ables as risk factors for disability,there was no obvious reason forlimiting this study to individualswith only LBP, even though theyare the largest group in most studiesof musculoskeletal pain. We havepreviously published normative dataon psychological factors in pati-ents with chronic pain at differentpain sites, and no difference wasfound across pain sites for these

variables.12 In addition, only studiesthat included interventions directedat psychological risk factors (eg,unhelpful beliefs, activity avoid-ance, mood disturbance, fears ofpain or reinjury) were included. Thestudies that met these criteria are

summarized in Table 3. Studies thatused comparison groups but notrandomized assignment to treatmentconditions were excluded from thistable but are included in the discus-sion, as they reflect applied research,where randomized allocation to

Table 1.Summary of Different Types of Flags

Flag Nature Examples

Red Signs of serious pathology Cauda equina syndrome, fracture, tumor

Orange Psychiatric symptoms Clinical depression, personality disorder

Yellow Beliefs, appraisals, and judgments Unhelpful beliefs about pain: indicationof injury as uncontrollable or likely toworsen

Expectations of poor treatment outcome,delayed return to work

Emotional responses Distress not meeting criteria for diagnosisof mental disorder

Worry, fears, anxiety

Pain behavior (including paincoping strategies)

Avoidance of activities due toexpectations of pain and possiblereinjury

Over-reliance on passive treatments (hotpacks, cold packs, analgesics)

Blue Perceptions about the relationshipbetween work and health

Belief that work is too onerous and likelyto cause further injury

Belief that workplace supervisor andworkmates are unsupportive

Black System or contextual obstacles Legislation restricting options for returnto work

Conflict with insurance staff over injuryclaim

Overly solicitous family and health careproviders

Heavy work, with little opportunity tomodify duties

1. Combination of various pain syndromes

Pain[MeSH:NoExp] OR Abdominal Pain[MeSH] OR Arthralgia[MeSH] OR Back Pain[MeSH]OR Chest Pain[MeSH:NoExp] OR Facial Pain[MeSH:NoExp] OR Headache[MeSH] OR NeckPain[MeSH] OR Neuralgia[MeSH] OR Pain, Intractable[MeSH] OR Pain, Referred[MeSH]OR Shoulder Pain[MeSH] OR Pain Threshold[MeSH] OR Pelvic Pain[MeSH:NoExp]

Neck/Shoulder Pain[tiab] OR Low Back Pain[tiab] OR Back Pain[tiab] OR Whiplash[tiab] OR BackDisorders[tiab] OR Musculoskeletal Pain[tiab] OR Fibromyalgia[tiab] OR Pelvic Pain[tiab]OR Shoulder Pain[tiab] OR Low Back Disability[tiab]

2. Combination of search words for psychological factors

Psychological Risk Factor*[tiab] OR Yellow Flags[tiab]

Risk Factors[MeSH]

Behavioral Symptoms[MeSH] OR Mental Disorders[MeSH] OR Psychology[MeSH]OR Psychology[Subheading]

3. Combination of 1 and 2�1,241 citations

Figure.Search strategy.

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interventions is not always feasiblebut from which potentially usefulinformation can be gained.

Can Yellow FlagsInfluence Outcomes inPeople With Acute orSubacute Low Back Pain?In this section, we review the avail-able evidence as to whether yellowflags are related to future pain anddisability and, therefore, are truly“risk factors.” Details of the 12reviews, their main findings, andimplications for the role of yellowflags are shown in Table 2.

Initial MethodologicalObservationsBefore examining the reviews, it isimportant to consider 2 aspects ofmusculoskeletal pain that may affectour understanding of the studies:the often recurrent, episodic natureof the pain and the problem of con-fusing pain intensity with disabilityas an outcome measure. It is wellestablished that most musculoskele-tal pain is recurrent in nature. Thus,a systematic review of 15 prospec-tive studies13 revealed that 73% ofpatients with acute LBP had at leastone recurrence of LBP in the follow-ing year and most continued to haveepisodes of significant pain and dis-ability. These findings challenge theconcept of chronicity as a continu-ous development and reliance on thenumber of weeks since onset, (eg,using 4 or 12 weeks as a point fordetermining risk). The recurrentnature of the pain may make timejudgments unreliable because thepoint of onset is difficult to deter-mine and because there is consider-able clinical variation, not to men-tion variation in when help might besought from primary care providers.

The second issue is defining the out-come point for predictive purposesin studies in which there is a mix ofpain intensity and functional out-

come variables. Pain and disabilityoften are treated as equivalent, butepidemiological research has shownthat significant proportions (at least40%) of people in the communitywho report having chronic pain donot report significant levels of dis-ability due to that pain.14 Similarproblems arise in trying to integrateclinical outcomes with return-to-work rates because these rates areknown to be influenced by a host ofblue and black flag factors ratherthan treatment alone. There is evi-dence, for example, that manyinjured workers return to workdespite their persisting pain.15 Thistendency to confuse outcomes fromwhat may be different domains hasmade it more difficult to draw clearconclusions about predictors andrisk factors. Nonetheless, we believethat, with these caveats in mind,there is sufficient clinical material tomerit evaluation.

What Do the Data Tell Us?Within these reviews, a large num-ber of prospective studies have exam-ined the relationship between variousyellow flag variables and future clinicaland occupational outcomes. The ear-liest review of predictors16 identified37 studies that examined the devel-opment of back and neck pain. A con-sistent relationship was foundbetween psychological factors andthe onset of pain, as well as the tran-sition from acute to chronic painproblems. These factors includedstress, distress, and anxiety, as wellas measures of depressed mood. Lin-ton16 found that certain beliefs,including fear-avoidance beliefs andcatastrophic thoughts, were stronglyassociated with the development ofdisability following onset of pain.Passive coping strategies, such aswaiting for someone else to help orresting, were associated with pooroutcomes, and pain behaviors cou-pled with disability were a risk factorfor future back pain problems. Fouradditional early reviews also con-

cluded that psychological variablesare important determinants of futurepain and disability.17–20

There is evidence for both yellowflags (fear, beliefs in severity ofhealth conditions, catastrophizing,and poor problem solving) and blueflags (low return-to-work expect-ancies and lack of confidence inperforming work-related activities)as risk factors for long-term workdisability.21 There also is evidencefor the influence of pain severityand level of depressive symptomson the transition to chronicity.21

Indeed, it appears that depressionespecially is associated with a num-ber of negative outcomes.22 There isagreement in a further systematicreview23 on the importance of dis-tress, yet with only limited evidencefound for the role of fear-avoidancebeliefs in the early development ofpain and disability. There also isevidence of risk factors other thanyellow flags. In another systematicreview of 7 prospective studies meet-ing stringent criteria, including onlyusing studies of workers who hadhad less than 6 weeks of sick leave,prognostic factors found for durationof sick leave included higher initialdisability levels, specific LBP, olderage, female sex, more social dysfunc-tion and more social isolation,heavier work, and receiving highercompensation.24 Thus, it is impor-tant to understand yellow flags incontext and to appreciate that theydo not operate in isolation fromother factors.

Three recent reviews provide in-sight into the most current investi-gations where more-sophisticateddesigns have been used. Leeuw andcolleagues25 in a narrative reviewof support for the “fear-avoidancemodel” found an increasing body ofevidence that fear-avoidance beliefs,catastrophizing, avoidance behav-ior, distress, and pain behavior areimportant in the development of

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pain, disability, and lowered per-formance. A systematic review of45 studies26 showed that higherpain severity at baseline, longer painduration, multiple-site pain, previouspain episodes, anxiety or depres-sion, higher somatic perceptions ordistress, adverse coping strategies,low social support, older age, higherbaseline disability, and greatermovement restriction were signifi-cant prognostic indicators for pooroutcomes. A review of 9 screeninginstruments showed that work statuswas best predicted by fear-avoidancebeliefs about work and the per-ceived chance of returning to work,functional limitations were bestpredicted by poor sleep and fear-avoidance beliefs, and pain was bestpredicted by baseline pain intensity,pain duration, and coping strategies,whereas depression and functionwere predictive of all 3 of theiroutcomes.27

What Inferences Can Be Drawn?Taken as a whole, the evidenceshows a clear relationship betweenpsychological yellow flags and futureclinical and occupational outcomes.Some factors such as depression,catastrophizing, pain intensity, andbeliefs about pain are quite consis-tently observed to be associated withoutcomes. Those who catastrophizefrequently, are depressed, haveintense pain, and hold high fear-avoidance beliefs are more likely todevelop persistent pain problems.These variables may be consideredwithin a moderator or mediatorperspective.

Moderators (or treatment effectmodifiers) are baseline characteris-tics that influence the outcome oftreatment. Thus, people with legpain as well as back pain mightimprove less with a particular type oftherapy. Mediators are factors thatchange during or as a consequenceof treatment and thereby influenceoutcome. Thus, it might be hypoth-

esized that an increase in exercisetolerance in physical therapy mightbe mediated by reduction in fear ofmovement, or the benefits of anexercise program for a person withheightened anxiety about his or hersymptoms should be enhanced if theanxiety were relieved as part of thetreatment process.

Despite the strength of the evidencesupporting the prognostic value ofmany yellow flags, it is clear thattheir strength is variable across stud-ies, and there is dispute amongauthors as to their relative impor-tance. For example, the influence offear-avoidance beliefs is questionedin one review28 and supported inanother review.29 However, themost recent systematic review ofindividual risk factors for the devel-opment of disabling, persistent backpain30 (published since the data forthis review were collated) has con-firmed that the weight of current evi-dence supports the yellow flaghypothesis, with maladaptive paincoping behaviours, anxiety, anddepressive features being especiallysalient factors. Even so, althoughthese factors may have relevance atthe group level, there is concernabout their reliability at the individ-ual level; therefore, an importantquestion is whether our knowledgeabout psychological risk factors canbe applied to individual cases in theclinic. In recognition of this con-cern, most guidelines recommend a2-phase process, with questionnairesbeing supplemented by a clinicalinterview.31 Despite these cautions,there is reasonably consistent evi-dence supporting the idea of yellowflags as risk factors for adverseoutcomes.

Priorities for Further ResearchPriorities for further research are:

• Further clarify the mechanisms bywhich yellow flags, individually and

in combination, affect the develop-ment of persistent pain disability.

• Investigate the relationship amongyellow flags, occupational factors(blue flags), and wider contextualfactors (black flags).

Can Interventions ThatTarget Yellow FlagsAchieve Better Outcomes?Challenges inDeveloping Screening ToolsIn appraising the literature, it isimportant to reflect initially on thechallenges in developing screeningtools. First, different factors may beimportant at different stages, such asinitiation, first onset, continuation,and consequences of disease or ill-ness.32 Second, given that screen-ing is never 100% accurate, therehas to be a “trade-off” betweenfalse-positives and false-negatives. Inother words, there is concern bothfor missing someone truly at risk andfor identifying someone as at riskwhen, in fact, he or she is not at risk.Given that the purpose of assessingthe presence of yellow flags is toidentify those possibly at risk offuture problems rather than to makea clinical diagnosis, it can be arguedit is better to be over-inclusive so asto minimize the chances of missing apositive case, even at the risk ofincluding more cases that turn out tobe negative (false-positive). Thus, ithas been argued that although such ameasure needs to have high sensitiv-ity, it could have low specificity.33,34

Most guidelines on the applicationof risk assessment in early musculo-skeletal pain recommend using acombination of interviews, impres-sions formed during examination,and brief, validated questionnaires.31

Two compendiums are now avail-able to assist in identifying psycho-metrically sound instruments forspecific needs.10,11 However, manyof the instruments seem more appro-priate for patients with long-standing

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pain, and because screening is nec-essarily required to be brief to have achance of being used, a single com-posite measure with a small numberof items is likely to be preferred overmultiple instruments that cover thefull range of possible risk factors.One example of a brief, compositemeasure recommended by the Acci-dent Compensation Commission’scompendium is the Orebro Musculo-skeletal Pain Screening Question-naire.35 This questionnaire contains24 items and takes about 5 minutesto complete. The items provide atotal score that is an estimate of risk,but the instrument also provides abasis for probing possible problemareas in a subsequent clinical inter-view. A recent systematic reviewconcluded that the instrument hasmoderate predictive ability and thatits use as a screening measure is war-ranted in clinical guidelines and rou-tines.36 A short (10-item) form of thisscale recently has been developedand may enhance its early use in pri-mary care settings.37

Another recent example of an instru-ment that has some empirical evi-dence is the Start Back Tool, whichwas developed for patients withLBP seeking primary care.38 This9-item tool allocates individuals intolow-risk, medium-risk, and high-riskgroups. In an initial follow-up studyof patients receiving primary careto determine predictive ability, itwas shown that 17% of the low-risk group, 53% of the medium-riskgroup, and 78% of the high-riskgroup had disability at the 6-monthfollow-up.38 These examples indi-cate there are instruments avail-able that can help clinicians to iden-tify yellow flags and assess risk atthe first consultation in primarycare.10,11,36 A direct comparison ofthe utility of the Start Back Tool andthe Orebro Musculoskeletal PainScreening Questionnaire is providedelsewhere.39

Some Caveats in theUse of Screening ToolsIt would appear, therefore, thereare a number of tools of potentialutility in the identification of pati-ents at risk for acute or subacutepain, but a number of caveats are inorder. First, the accuracy of screen-ing is “population-dependent,” anda judgment on trade-offs betweensensitivity and specificity willdepend on the purpose of screening.Second, because the nature of thesubgroups that emerge is dependentupon the patient characteristicsappraised in the assessment, theclinical validity of the instrumentsused and differences in validity andreliability between tools purport-ing to measure the same constructwill have an important influenceof the utility and relevance of thescreening.

The Challenge of PreventionA remaining question is whetherinterventions initiated in responseto someone having been identifiedas being at risk might prevent thedevelopment of long-term disabilityand poor return-to-work outcomes.Indeed, the identification of poten-tially modifiable prognostic factorsarguably is the most important con-sideration of all, and this questionhas been an increasing focus of inter-vention studies.40 The results to dateare reviewed next.

The Case for Linking RiskIdentification With InterventionsThe idea of allocating patients totreatment on the basis of their ini-tial presenting characteristics islong-standing.41,42 However, to date,relatively few studies have shownattempts to link interventions to psy-chosocial risk factors in people seek-ing help for musculoskeletal pain. Areview of intervention studies forwork-related LBP29 revealed a strongconcordance between some work-place risk factors and interventionsfor acute LBP (eg, workplace tech-

nical and organizational interven-tions, graded activity exposure, cog-nitive restructuring of pain beliefs),but not other interventions (eg,exercise, back education, and return-to-work coordination). Perhaps sur-prisingly, even with 2 generallywidely accepted psychological riskfactors (emotional distress and lowjob dissatisfaction), there was verylittle evidence of concordance withinterventions.29

Inclusion and Exclusion CriteriaIn the present review, interventionstudies of people seeking help foracute or subacute musculoskeletalpain (mainly back pain), both workrelated and not work related. (Thesearch strategy was as previouslydescribed.)

Initial examination revealed that ofthe 18 studies that met the inclusioncriteria, only 6 studies43–48 appliedpsychological interventions to indi-viduals who had high psychologicalrisk factors (eg, a high psychologicalrisk screening score). Of these 6studies, only 3 specifically selectedcases according to high psychologi-cal risk levels.43,46,49 However, 11studies, including the 6 studies men-tioned above, demonstrated thatinterventions targeting psychologi-cal risk factors resulted in betterfunctional or return-to-work out-comes than those that were moresymptom-based and did not targetpsychological risk factors (oftencalled “usual care”). In contrast, 6studies50–56 did not find targetingpsychological risk factors for inter-vention was differentially effectiveon functional outcomes relative tothe alternative (mostly usual care)treatments.

Four other studies did not target psy-chological risk factors per se, butmainly added graded activity or exer-cise or advice to usual care.57–60 Theresults were mixed. Two of the stud-ies59–60 showed reduced sick-list

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days from work, but not disability,in the intervention groups at follow-up, 1 study showed increased dis-ability in the treatment group,57 andanother study58 showed reduceddisability. However, a workplaceintervention57 by itself (ie, withoutgraded activity) was found to beassociated with reduced sick-listdays.

In summary, despite some strongfindings that are clearly supportiveof the yellow flag hypothesis, theevidence collated here indicates amixed picture. The possible reasonsfor this finding are examined next.

Methodological Difficulties inInterpretation of the FindingsFirst, it was evident that the term“usual care” is potentially mislead-ing, as its meaning varies in differentcountries. In the Netherlands, forexample, usual care can includeattention to psychological risk fac-tors and encouragement to resumeactivities by a general practitioner. Inthe United Kingdom, it is more gen-eral and symptom-relief focused. Fur-thermore, closer examination of the7 studies50–56 that showed no effectfor targeting psychological risk fac-tors reveals that none of themselected patients for interventionbased on the presence of heightenedpsychological risk factors. Instead,patients were selected if they wereseeking help for back pain of lessthan 6 months’ duration. In addition,the groups treated in these studiesgenerally had low levels of psycho-logical risk factors in the first place,which means there was little roomfor improvement on these dimen-sions. Only one placebo-controlledintervention61 was found, but as theparticipants generally had low levelsof psychological risk factors initially,assessment of this aspect is prob-lematic. However, that study didshow that combined advice (educa-tion about pain, reassurance, and

encouragement to gradually increaseavoided activities using cognitive-behavioral principles) combinedwith a home exercise program didachieve better functional gainsthan the attention-placebo condi-tion, which is consistent with theyellow flag hypothesis.

These methodological differencesamong studies, as well as the smallnumber of studies that have directlytested the hypothesis underpinningearly intervention for yellow flag fac-tors, constrain the conclusions thatcan be drawn on this issue. How-ever, as might be expected on theo-retical grounds, it appears that whenpatients are selected for psychologi-cal intervention on the basis of psy-chological risk factors, the results aremore consistent with the yellow flaghypothesis.

A second methodological issue con-cerns the nature of the interven-tions and the personnel involvedin the 18 studies. The interven-tions varied considerably in con-tent—some were mainly advice,58

whereas others included exercisesor graded activity59 or advice,graded activity, and psychologicalstrategies.47 In many studies, thepsychological intervention, oftendescribed as based on cognitive-behavioral principles or operant-behavioral principles, was providedby physical therapists or generalmedical practitioners. In other cases,a psychologist (sometimes called abehavior therapist or psychothera-pist) provided the psychologicalintervention, usually working along-side members of other disciplines.

It might be relevant that in the 7studies in which psychological inter-ventions did not yield any benefitover usual care, none used a psy-chologist to deliver the psychologi-cal intervention. In addition, in 7 ofthe 11 studies that did demonstratea benefit for addressing psychologi-

cal risk factors, a psychologist (orequivalent) was used. This findingsuggests that, in addition to select-ing patients with psychological riskfactors, the intervention may bemore effective if someone with clearexpertise in this domain adminis-ters it. This point is reinforced byrecent research indicating that manyprimary care providers (physiciansand physical therapists) lack theskills and confidence in applyingpsychological interventions as partof their usual work.62,63 However, ina recent trial in the United King-dom,64 significant reductions in dis-ability were achieved by a mixedgroup of patients with subacute andchronic LBP treated predominantly(81%) by physical therapists usingcognitive-behavioral methods. Thisfinding supports the value of pro-viding specific training in thesemethods for primary care clinicians.There may be merit in exploring con-joint clinical management, as oftenis found in tertiary pain manage-ment programs. However, no studiesto date have tested the importanceof the discipline delivering theintervention, a possible question forfuture research.

A third methodological issue is thevariable nature of the psychologicalinterventions found in this review,raising questions about the impor-tance of treatment content and fidel-ity. In some studies, psychologicalinterventions amounted to littlemore than education about pain andinjury, attempted reassurance that allwas well, and encouragement toreturn to normal activities, includingwork.65,66 In some studies, theseinterventions appeared quite similarto those provided to the comparisongroup,50,51 which could have dilutedthe findings. In other cases,46,48 thepsychological interventions alsoinvolved training in basic problem-solving strategies, ways of identify-ing and dealing with unhelpfulthoughts, graduated upgrading of

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activities using goal setting, andconsistent reinforcement by the stafffor progress. Interestingly, in onestudy,47 those patients in the fear-avoidance-based therapy who hadhigher fear-avoidance beliefs seemedto benefit more from that interven-tion relative to those who did notshare this characteristic.

Other researchers have identified arange of methodological issues thatmight explain the lack of consis-tent treatment effects for psychoso-cial interventions across trials.53,54,66

Without therapists appropriatelytrained in flag identification and man-agement, provision of an adequatecourse of specified treatment, anddemonstration of treatment fidelity,it is not possible to form a clear viewon the efficacy or cost-effectivenessof psychosocial interventions in con-trolled trials.

Finally, we identified patient selec-tion as a potentially important influ-ence on the findings reported. In thestudies that did identify patients whohad marked psychological risk fac-tors43–48 and provided interventions(by a psychologist or equivalent) thattargeted these risk factors, the out-comes were consistent with the yel-low flag hypothesis in every case.

Concordant with this observation, inone of the few RCTs to test the roleof risk factors for disability inpatients with chronic pain,67 it wasfound that matching patients iden-tified by these risk factors to levelof intervention was important inachieving better and more economicreturn-to-work outcomes. In thatstudy, those individuals identifiedas at high risk benefited more froma more-comprehensive intervention,whereas those at low risk weretreated effectively with a simpler andcheaper intervention.

Further support for the importanceof selecting patients for psychologi-

cal intervention can be found in anumber of nonrandomized controlledtrials, as well as in a recent RCTwith a mixed-injury sample. Onenonrandomized controlled study68

showed that a structured psycholog-ical intervention by psychologists forinjured workers who had beenselected on the basis of having oneor more elevated psychological riskfactors was significantly more effec-tive in achieving return to work thana usual care comparison sampletreated earlier. A similar interventionaimed at reducing risk factors forprolonged work disability (eg, paincatastrophizing, fear of movementand reinjury, perceived disability)and conducted mainly by physicaltherapists and occupational thera-pists, with individuals selected onthe basis of elevated scores on mea-sures of these psychological risk fac-tors, also appeared quite effective.69

In that nonrandomized clinical trialwith a sample of individuals whohad been work disabled due to whip-lash symptoms, 75% of individuals inthe psychologically informed treat-ment group returned to work com-pared with 50% who followed usualtreatment.69

More recently, in another nonran-domized controlled trial that usedinjured workers from a separate siteas a comparison group,70 it wasfound that an integrated occupa-tional, clinical, case managementintervention that was individually tai-lored, cognitive-behavioral methodsachieved better return-to-work out-comes at 6 months posttreatment,but only in those workers who wereassessed as at high risk for long-termdisability. At 3 months posttreatmentin those workers assessed as beingat only moderate risk for poor out-comes, there was no differencebetween the treatment group andthe usual care group.

Similar results were reported inanother RCT of workers who were

not seeking help.71 Those workersconsidered at high-risk for long-termsickness absence, as determined by a34-item self-report questionnaire (theBalansmeter), received either a stan-dard care intervention or an experi-mental intervention that targetedidentified specific concerns accord-ing to the case. In most cases, thetreatment was provided by an occu-pational physician trained in thistype of intervention. A small propor-tion of workers also received someform of problem-focused counseling.At the 1-year follow-up, the resultsindicated significantly fewer sick-listdays for those in the experimentalgroup.

What Can We ConcludeFrom the Available Evidence?Overall, from the evidence gatheredhere, the studies that targeted inter-ventions on known psychologicalrisk factors for disability seemed toreport more consistently positiveresults relative to those interventionsthat either ignored these risk factorsor provided omnibus interventionsto people regardless of psychologicalrisk factors. It seems that the identi-fication of those with these risk fac-tors is an important precursor to psy-chological interventions. However,simple application of these interven-tions to all patients, regardless of riskstatus, is ineffective and likely to beuneconomical.

When this evidence is consideredalongside a recent article on blueflags72 that described the benefits tobe gained from linkages betweeninterventions and the workplace,there does seem to be an increas-ingly compelling case for early inter-ventions targeting yellow flags spe-cifically in those with these riskfactors combined with an associ-ated and simultaneous workplaceintervention.6,73 Some preliminaryevidence in support of this modelwas found in a non-randomizedstudy74 in which early screening

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(risk identification) leading to fast-track intervention (that includedsimultaneous clinical and workplaceelements) was associated with sub-stantially improved outcomes inpatients identified as at high riskcompared with similar patientstreated previously using more-traditional, sequential approaches.

Priorities for Further ResearchPriorities for further research are:

• Developing specific treatments thataddress yellow flags in the acuteand subacute period.

• Developing a system for matchinginterventions to the yellow flags.

• Integrating such interventions intothe broader treatment of patientswith musculoskeletal pain.

SummaryThe idea that psychological yellowflags may instrumentally influencethe development of persistent paindisability has generated a plethora ofresearch articles. As this databasegrows, various psychological factorshave consistently been linked withpoor prognosis. A point of conten-tion is not whether yellow flags havean impact, but rather which vari-ables are the central ones. Theoreti-cal models have been helpful in guid-ing this research, but none fully

account for all cases. Despite gaps inour knowledge of yellow flags, therenow exist instruments for assessingyellow flags that work reasonablywell from a clinical standpoint.

The yellow flag proposition carrieswith it the promise of early interven-tions that might avert the develop-ment of disability. This is an enor-mously challenging task because itbuilds directly on integral knowl-edge of the causal factors, as well asdeveloping interventions that canalter these causal factors effectively.If this task were not enough, it alsorequires the application of the inter-vention early enough to actually havea preventive effect. The studies con-ducted to date have been boldattempts to achieve this task. How-ever, in their boldness, various meth-odological, logistic, and theoreticalbarriers have been side-stepped,requiring caution in drawing firm con-clusions. Yet, our sense is that whencandidates are carefully selected onthe basis of the presence of yellowflags and when an intervention knownto address these factors is competentlyapplied, good outcomes are to beexpected. On the contrary, whenpatients are not selected for yellowflags and psychological interventionsare provided indiscriminately, the out-comes tend to be disappointing.

The available evidence provides aconsistent picture that yellow flagsare prominent in the developmentof disability due to musculoskeletalpain. Tomorrow’s challenge is tobuild upon this base to providetimely and feasible interventions toachieve more consistently the resultsthat should be obtainable. This goalwould be facilitated by integratingsuch interventions into normal pri-mary care practice and attending tofactors, especially occupational fac-tors (ie, the blue flags72), which arediscussed further elsewhere in thisspecial issue.75

All authors provided concept/idea/projectdesign and writing. Dr Nicholas provideddata collection and analysis. Dr Watson andDr Main provided project management andconsultation (including review of manuscriptbefore submission).

The authors acknowledge the other mem-bers of the “Decade of the Flags” WorkingGroup who contributed to the discussionsand conclusions presented in this article:Mansel Aylward, Kim Burton, Peter Croft,Michael Feuerstein, Charles Greenough,Elaine Hay, Nick Kendall, Clement Leech,Partick Loisel, Ceri Phillips, Glenn Pransky,William S. Shaw, Mick Sullivan, JohanVlaeyen, Danielle A. van der Windt, Michaelvon Korff, and Gordon Waddell.

This article was submitted July 7, 2010, andwas accepted December 9, 2010.

DOI: 10.2522/ptj.20100224

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Table 2.Yellow Flags as Prognostic Factors for Persistent Pain and Pain-Associated Disabilitya

Review Article Scope Main Findings Comments Conclusions

Linton,16 2000 Critical review of 37 prospectiveinvestigations (11 prior toonset of back or neck pain,18 of patients with acute orsubacute pain, 8 of patientswith chronic pain); 29 studiesincluded here (not chronicpain)

29 studies pertained to priorto onset of pain tosubacute pain

Psychological variables wererelated to pain onset,particularly to thetransition from acute painto subacute or chronicpain

Emotional variables (eg,distress, anxiety, stress,mood), cognitive variables(eg, fear-avoidance beliefs,catastrophizing,expectations to get better),and behavioral variables(eg, coping, function) wererelated to future disability

This review also looked at therisk factors in relation tothe setting and time pointand found good generality

Emotional, behavioral, andcognitive variables arerelated to the transitionfrom acute to chronic pain

Support

Truchon and Fillion,17

2000Critical review of 18 studies Predictors of chronic

disability included aprevious history of LBP,results of certain clinicaltests (SLR, range ofmotion, neurologicaldeficits), a negative self-appraisal of one’s abilityto work, and jobdissatisfaction. The role ofcertain psychologicalvariables, includingcatastrophic beliefs aboutLBP, were promising.

Distress and pain severity infirst 3 wk were not goodpredictors of long-termdisability.

Noted limited number ofsuitable, prospectivestudies, but some of theearly findings appear atvariance with those ofmore recent studies,especially distress andpain severity

Some yellow flags werefound as predictors,whereas distress and painseverity were not found aspredictors

Partial support

Shaw et al,20 2001 Critical review of 22 prognosticinvestigations of workers withback pain

Self-perceived function, painreports, coping strategies,and pain behavior werefound to be related tofuture work status

Focused on a large numberof prospective studies

Good evidence for perceivedfunction and pain intensity

Limited evidence for coping(avoidance) and painbehavior

Support

Crook et al,18 2002 Systematic search andmethodological evaluation

Included 19 prospective studiesof people within 6 mo ofinjury

Psychological distress, self-perceived dysfunction, andpain were risk factors forfuture sick absenteeism

A rigorous review, with clearcriteria for inclusion and ofthe factors

Found distress, dysfunction,and pain to be risk factors

Support

Pincus et al,19 2002 Systematic review of 25prospective articles onpatients with acute orsubacute pain

Moderate effect (depressionor distress) and small effect(somatization) on futurepain and disabilityproblems

Selected studies based onprospective design andacute or subacute pain,estimates size of the effect

Distress (moderate effect)and somatization(small effect)

Partial support

Bair et al,22 2003 Narrative review of 10 clinicaltrials examining therelationship betweendepression and back pain

Depression was found to berelated to the onset ofback pain, higher levels ofpain intensity reports,more dysfunction, poorertreatment outcome, andchronicity

A very exhaustive reviewfocusing on depressionand pain

Depression is a veryimportant, but oftenoverlooked, aspect

Support

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Table 2.Continued

Review Article Scope Main Findings Comments Conclusions

Sullivan et al,21 2005 Selective review of 8 studieswith psychological variables

Pain-related fears, self-perceived health, paincatastrophizing, poorproblem-solving skills, andexpectations concerningrecovery were found to berelated to future workdisability

A selective review of worker-related psychosocial riskfactors for work disability

Selection of studies may leadto bias in conclusions

Emphasizes the need tointegrate workplace riskfactors

Worker-related psychologicalvariables increase risk forfuture work disability

Support

Steenstra et al,24

2005Systematic review of 7 studies

with psychological variablesand recruitment between1 and 42 d of sick leave

Self-perceived function(ES�2.4), pain intensity(ES�1.1), and severedepression (ES�2.47) werefound to predict durationof sick leave

Anxiety (2 studies) not foundto be reliable predictor

Included only 7 studiesStrict inclusion criteria of only

6 wk sick-leave duration

Function, pain, anddepression found to haverather large effects

Support

Pincus et al,23 2006 Critical review of 9 prospectivestudies where patients wererecruited �3 wk from onset

3 of 7 relevant studies foundfear-avoidance beliefs tohave a small effect onfuture pain and disability

Only 7 studiesFocus is on fear, but article

points out the role ofdistress

Fear beliefs may not be asrelevant in the early stagesas later on

Distress seems moreimportant

Partial support

Leeuw et al,25 2007 Narrative, critical review ofstudies of relevance to the“fear-avoidance” model

Fear-avoidance beliefs,catastrophizing, avoidancebehavior, and painintensity were found to beimportant for future pain,disability, and performance

Extended review that placesstudies in relation to thefear-avoidance model

Discusses dysfunction asavoidance behavior

There is mounting evidenceto support the mainfeatures of the fear-avoidance model

Support

Mallen et al,26 2007 Systematic review of 45 studiesof prognostic factors inprimary care

11 factors at baseline foundto be associated with pooroutcome: pain severity,pain duration, multiplepain sites, previous pain,anxiety or depression,distress, coping strategies,social support, age,dysfunction, andmovement restriction

An exhaustive review, withspecial relevance forprimary care services

11 factors, including yellowflags, may be genericprognostic indicators

Support

Melloh et al,27 2009 Systematic review of screeninginstruments publishedbetween 1970 and 2007predicting work status,function, and pain

Extracted variables from studiesto determine what predictsoutcome

13 studies included

Work status best predictedby fear-avoidance beliefsabout work and perceivedchance of being able towork; occupational factorsalso important

Functional limitations bestpredicted by sleep and fearavoidance

Pain best predicted byintensity, duration, andcoping

Depression and functionare predictive of all 3outcomes

Review focuses on actualscreening instruments andthus is a relevant test ofthe yellow flags’ utility topredict

Psychological andoccupational variables aregood predictors andshould be included inearly identificationscreening

Depression and functionpredict all 3 outcomes,whereas fear, sleep, andexpectations aboutoutcome were morespecific

Support

a LBP�low back pain, SLR�straight leg raise, ES�effect size.

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Table 3.Early Intervention Randomized Controlled Studies (2000–2008) in Patients Seeking Help for Musculoskeletal (Mainly Spinal) Paina

StudySample and Design:

CT/RCT Intervention Control Outcome Comment

Linton andAndersson,43

2000

243 patients with subacuteLBP (mainly) (stillworking but missingdays); self-perceived riskof developing chronicproblem (RCT)

Six 2-hr group CBTsessions withpsychologist

2 levels of informationon back care,physical therapy

All groups improvedon pain, disability,and mood, withsignificantly less lostwork time over12 mo.

Sample of patients withmixed pain durations,but all working andmissing days dueto pain. Resultsconsistent with role ofskills in managing workdespite pain vsinformation alone. Painself-management skillsalso taught. Consistentwith yellow flaghypothesis.

Hagen et al,65

2000457 patients sick-listed 8

to 12 wk for LBP (RCT)At spine clinic, 1 session

with advice ongood prognosis andimportance ofremaining active toavoid development ofmuscle dysfunction.Walking encouraged,advice on exercisingat home. Advice onhow to manage theback pain and how toresume normalactivities.

Usual care by GP At 12-mo follow-up,68.4% inintervention group vs56.4% in controlgroup had full RTW.

Results similar to those ofprevious studies of thistype, but raise thequestion of whethermore-extensiveintervention might haveachieved better resultsfor those not RTW at12-mo follow-up.Consistent with yellowflag hypothesis.

Verbeek et al,56

2002Patients with LBP on sick

leave for at least 10 d(RCT)

Occupational physician(based on guidelines,biopsychosocialassessment,intervention inidentified RTWobstacles,encouragement toremain active); othertreatments via GP orphysical therapist oncase basis. Workplacesupervisor alsoadvised onmanagement.

Reference group:no review withoccupationalphysician in first3 mo, buttreatment asusual by GP,physical therapist,or specialist.Workplacesupervisor givensame managementadvice asintervention group.

At 3- and 12-mofollow-ups, nodifference betweengroups on work timelost and healthoutcomes (bothimproved), butrecurrences morefrequent inintervention group.

Many similarities incontent of control andtreatment groups. Lowdistress in both groups.Not really testingyellow flag hypothesis.

Loisel et al,44

2002104 workers absent from

work �4 wk due towork-related LBP(mean�38–43 daysacross 4 groups) (RCT)

ComprehensiveSherbrooke model(combinedoccupational andclinical interventions)

3 groups (clinicalintervention,usual care, andoccupationalintervention)

At 6.4-yr follow-up,all interventionsachieved gains, butintervention grouphad fewer days onbenefits and morecost beneficial.

Including workplacein intervention (inaddition to clinicalinput) seems importantfor retention at work,consistent with otherfindings andimportance of blueflags. Also addressedproblems at individuallevel regarding RTW.Consistent with yellowflag hypothesis.

van den Houtet al,45 2003

84 employees, recently onsick leave due tononspecific LBP; meansick leave�8 wk, butmean pain duration ofcurrent episode�1.5 y(RCT)

Graded activities withbehavioral principles� problem-solvingtraining

Graded activities �education

Intervention wasassociated withbetter long-termwork status.

Mixed group of patientswith acute and chronicpain, but all had beenworking despite painuntil mean of 8 wkbefore treatment.Consistent with yellowflag hypothesis.

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Table 3.Continued

StudySample and Design:

CT/RCT Intervention Control Outcome Comment

Damush et al,58

2003211 patients with acute

LBP (�90 d); excludedany receiving disabilityinsurance paymentsor in the process ofapplying for back paindisability (RCT)

Brief (3-session) groupprogram, withtelephone follow-up,aimed at increasedfunction, health status

Usual care At 12 mo, interventiongroup significantlybetter on the Roland-Morris DisabilityQuestionnaire,mental functioning,self-efficacy tomanage acute LBP,time spent inphysical activity,reduced fears ofmovement/reinjury.

Brief intervention may havebeen enhanced by lack ofpatients involved indisability insurance, butresults consistent withyellow flag hypothesis.

Gatchel et al,46

2003124 selected (high risk of

disability) patients withacute LBP (all �10weeks since onset)(RCT)

Functional restoration(individualized psycho-social and physicalreconditioning)over 3 wk

Individualized usualcare (medical,physical therapy,chiropractic,injections, electricalstimulation)

Intervention group hadsignificant gains overcontrol group inwork, health careutilization, medicationuse, and self-reportedpain.

One of few studies to selectfor high psychosocial riskfactors and then interveneon basis of those factors.Findings consistent withyellow flag hypothesis.

George et al,50

200366 patients with LBP of

�8 wk duration seen atphysical therapy clinics;selection not based onpresence of psycho-social risk factors (RCT)

Fear-avoidance-basedphysical therapy(4 wk); both inter-ventions 1 hr persession, with contentincluding exercises,education, exerciseupgrading. Natureof education andexercises differed. Inthe fear-avoidancegroup, a specificgraded-exerciseprogram based onquota was used.

Standard physicaltherapy (4 wk),similar format toother intervention,but education moreabout anatomyand pathology.Home exercisesencouraged andmonitored by log.

Both groups improvedon disability and painmeasures at 4 wkand 6 mo post-treatment. Fear-avoidance beliefsabout activity (notwork) were morereduced in theintervention thattargeted the fear-avoidance beliefs onboth follow-upoccasions.

As patients were not selectedon basis of high fear-avoidance beliefs, difficultto show a differentialoutcome. Treatments mayhave been too similar aswell, but those with higherfear-avoidance beliefs didseem more responsive tothe relevant intervention.

Staal et al,60

2002134 workers with �4 wk

of sick leave due toLBP (mean�41–43 d);mean duration ofsymptoms�8–8.5 wk(RCT)

Individually supervisedgraded activity usingoperant behavioralprinciples; educationabout pain, exercisingto quota, set RTWgoal, graduated RTW

Usual care: guidanceand advice fromoccupationalphysician and GPaccording to LBPguidelines (includedphysical therapy,manual therapy,chiropractic)

At 6 mo, gradedactivity group hadsignificantly fewerdays absent fromwork vs usual caregroup. Functionalstatus and pain notsignificantly differentbetween groups.

Results might be contrastedwith those of Anema et al.57

Suggest need to examinecontent of interventionswith same name. Anotherstudy that finds sustainedRTW is not synonymouswith absence of pain anddisability. Results consistentwith yellow flag hypothesis.

Karjalainen etal,59 2004

164 workers with subacuteLBP of �4 wk and�3 mo duration (meandays on sick leave inprevious 3 mo�14.7–15.8) (RCT)

2 interventions: (1) brief“back school” (2.5–3 hr) (exercise, advice,discussion about pain,encouragement forRTW, being activedespite pain, bodymechanics; conductedby occupationalphysician andphysical therapist)and (2) same as above,plus work-site visit andadvice by physicaltherapist

Usual health care byGP (ie, did notattend specialoccupational healthcenter in contrastto other 2 groups)� leaflet ofinformation aboutLBP

At 2-yr follow-up, nodifferences betweengroups on pain,disability, andquality-of-lifemeasures. Costs ofLBP treatment lowerin both interventiongroups vs usual caregroup; days absentfrom work fewer inboth interventiongroups vs usual caregroup.

Usual health care may bedifferent from others ofsame name, especially inNetherlands, but bothintervention groups weregiven very brief treatment,which may explain whythere were no differences indisability and quality-of-lifemeasures. More-extensiveinterventions might havebeen more effective.Information insufficient forretention at work. Althoughpatients not selected forhigh psychosocial riskfactors, results broadlyconsistent with yellow flaghypothesis.

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Table 3.Continued

StudySample and Design:

CT/RCT Intervention Control Outcome Comment

Schiltenwolfet al,47 2006

64 patients with a first-time sick leave of 3–12 wk due to LBP (RCT)

BT group: received samefunctional restorationprogram as the controlgroup, but included abehavioral therapycomponent (problemsolving, stressmanagement, andpartner involvement,as indicated)

MT group: receivedsame functionalrestoration programof individualphysical therapy,group therapy inwater, workout,back school withstretching andstrengthening,improving mobilityand body control,plus passivetreatments(massage andphysical therapy)

Both groups improvedposttreatment, but at6 mo, the BT groupimproved on multipleparameters relative tothe MT group, whichdeteriorated. At 2 y, nosick leave by 59% in BTgroup vs 10% in MTgroup.

The addition of behavioraltherapy for dealing withstress and problemsgenerally seems to haveadded significantly tothe exercise/activityprogram. Resultsconsistent with yellowflag hypothesis.

Linton et al,48

2005185 patients seeking care

for nonspecific backor neck pain (allemployed), at risk fordeveloping long-termdisability; 96%employed, all with�4 mo sick leave inprevious year (RCT)

(1) CBT (with psychologist)group

(2) CBT (with psychologist)� exercise (with physicaltherapists) group

Minimal treatmentgroup; usual care(examination,reassurance, adviceon activities basedon currentguidelines)

At 12-mo follow-up, lesshealth care use andwork absence for bothtreatment groups vsminimal treatmentgroup. No difference inwork absence betweenthe 2 treatmentgroups.

Suggests that exerciseprogram did not addto outcome. Skills indealing with demandsof functioning despitepain seem important.Results consistent withyellow flag hypothesis.

Jellema et al,53

2005314 patients consulting

with nonspecific backpain of �12 wk durationor an exacerbation ofmild symptoms (RCT)

“Minimal InterventionStrategy,” 1–3 sessions;intervention by GP onlyusing guidelines

Usual care by GPs Both groups had largeimprovements inmedian level ofdisability within 3 moafter first session withGP. No real differencesbetween groups onother outcomemeasures (perceivedrecovery, sick leavedue to LBP, andpsychosocial measures).

Low level of psychosocialrisk factors at baselineand treatments notmatched to need. Notreally testing the yellowflag hypothesis.

Hlobil et al,55

2005134 workers with non-

specific LBP for at least4 wk prior to study, witheither full or partial sickleave due to LBP (RCT)

Graded activity group, 1-hrexercise session twice aweek until the workersachieved full regularRTW or when themaximum therapyduration of 3 mo wascompleted

Usual care by GP Graded activity groupachieved RTW soonerthan the usual caregroup, but nosignificant differencesin functional status orpain.

No specific psychosocialrisk factors identified oraddressed in eithergroup, other thanencouragement forRTW and explanationabout benign nature ofpain in the gradedactivity group. Suggestsspecific encouragementfor RTW early is helpful.Consistent with yellowflag hypothesis, but notspecifically addressingthe concept of yellowflags.

Hay et al,52

2005402 patients seen by their

GP for LBP of �12 wkduration (RCT)

Brief individualized painmanagement program(median�3 sessions) byphysical therapists (basiccognitive behavioraltechniques over a courseof 2 d with follow-upstudy days andmentoring)

Brief (median�4sessions) standardphysical therapyincluding manualtechniques

Both groups improved;similar outcomes onRoland-Morris DisabilityQuestionnaire at 3 and12 mo; no significantdifferences for pain,time off work, orpsychologicalmeasures.

Average baselinecatastrophizing anddepression low in bothgroups, which maymean that CBT unlikelyto confer advantageover standard care. Notreally testing the yellowflag hypothesis.

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Table 3.Continued

StudySample and Design:

CT/RCT Intervention Control Outcome Comment

Anema et al,57

2007196 workers sick-listed 2 to

6 wk due to nonspecificLBP (RCT)

Workplace intervention:workplace assess-ment, work modifi-cations, and casemanagementinvolving allstakeholders. Thosestill sick-listed at 8 wkrandomly assigned tograded activity groupor usual care group.

(1) Graded activity:biweekly 1-hourexercise sessionsbased on operant-conditioningprinciples

(2) Usual care

Time to RTW significantlyless for workplaceintervention. Gradedactivity had negativeeffect on RTW andfunctional status.Combined interventionhad no effect.

Different results forgraded activity in thisstudy relative to othersmay be related tonature and extent ofthis intervention here,which may not haveaddressed yellow flags.Compare with Staalet al.60 As with someother studies, supportsimportance of focus onRTW in intervention,which is consistent withyellow flag hypothesisin occupationalsettings.

Pengel et al,61

2007259 patients with subacute

LBP treated in physicaltherapy clinics. Allpatients recruited�12 wk since onset, butnot selected on basis ofpsychosocial risk factors.

Factorial design study,with advice(education, goalsetting, activityupgrading,reinforcement forattempts) comparedwith exercises and acombination ofadvice and exercise

Placebo/attentioncontrol, withdiscussion andinterest fromphysical therapist(no advice), plussessions of detunedshort-wave andultrasoundtreatments. Patientsasked not to haveother backtreatments during6-wk treatmentphase of study.

All groups improved overtreatment period andall maintained gains at1-y follow-up. Thecombined advice andexercise treatmentwas slightly moreeffective than eitherintervention individuallyand the placebo/attention control onmeasures of pain andfunctional activities at1-y follow-up.

As patients not selectedfor presence ofpsychosocial risk factorsand the levels of thesefactors were generallylow, this studyprovided only limitedsupport for the yellowflag hypothesis.

George et al,51

2008108 patients attending 3

physical therapy clinics;patients divided into 3treatment conditions;across conditions, meannumber of weeks ofpresent episode ofLBP�5.8–9.8, 50%–69%had prior history of LBP,and 70%–74%employed (RCT)

All 3 groups receivedsame standardphysical therapydescribed by Georgeet al.50 In addition,1 group was givengraded activity, and1 group was givengraded exposure(performance offeared activities undersupervision).

Standard physicaltherapy (TBCprotocols), asdescribed byGeorge et al.50

All 3 groups improved;no differences at 4-wkand 6-mo follow-upson disability, pain, paincatastrophizing, andphysical impairment.Fear-avoidance beliefsreduced in TBC andgraded exposuregroups, relative tograded activity group,only at 6 mo.No benefit to TBC byadding graded activityor graded exposure.

As in the 2003 studyGeorge et al,50 patientsnot selected on basisof psychosocial riskfactors, and inter-ventions in TBC hadmany elements incommon with gradedactivity and gradedexposure, so theadditional elementsmay not have beendifferent enough.

a CT�clinical trial, RCT�randomized controlled trial, CBT�cognitive-behavioral treatment, RTW�return to work, GP�general practitioner, TBC�treatment-based classification protocols, BT�behavior therapy, MT�biomedical therapy.

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doi: 10.2522/ptj.20100224 Published online March 30, 2011PHYS THER. 

and Chris J. MainMichael K. Nicholas, Steven J. Linton, Paul J. WatsonPatients With Low Back Pain: A ReappraisalPsychological Risk Factors (''Yellow Flags'') in Early Identification and Management of

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