Comparative Effectiveness of Conservative Interventions ... · Comparative Effectiveness of Conservative Interventions for Nonspeciﬁc Chronic Spinal Pain: ... physical aspects such

Critical Review

Comparative Effectiveness of Conservative

Interventions for Nonspecific Chronic Spinal Pain:

Physical, Behavioral/Psychologically Informed, or

Combined? A Systematic Review and Meta-Analysis

The Journal of Pain, Vol 17, No 7 (July), 2016: pp 755-774Available online at www.jpain.org and www.sciencedirect.com

Mary O’Keeffe,* Helen Purtill,y Norelee Kennedy,* Mairead Conneely,* John Hurley,*Peter O’Sullivan,z Wim Dankaerts,x and Kieran O’Sullivan**Department of Clinical Therapies, University of Limerick, Limerick, Ireland.yDepartment of Mathematics and Statistics, University of Limerick, Limerick, Ireland.zSchool of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.xMusculoskeletal Unit, Department of Rehabilitation Sciences, University of Leuven, Leuven, Belgium.

Abstract: Nonspecific chronic spinal pain (NSCSP) is highly disabling. Current conservative rehabili-

tation commonly includes physical and behavioral interventions, or a combination of these ap-

proaches. Physical interventions aim to enhance physical capacity by using methods such as

exercise, manual therapy, and ergonomics. Behavioral/psychologically informed interventions aim

to enhance behaviors, cognitions, or mood by using methods such as relaxation and cognitive behav-

ioral therapy. Combined interventions aim to target physical and also behavioral/psychological factors

contributing to patients’ pain by using methods such as multidisciplinary pain management programs.

Because it remains unclear whether any of these approaches are superior, this review aimed to assess

the comparative effectiveness of physical, behavioral/psychologically informed, and combined inter-

ventions on pain and disability in patients with NSCSP. Ten electronic databases were searched for ran-

domized controlled trials (RCTs) including participants reporting NSCSP. Studies were required to have

an ‘‘active’’ conservative treatment control group for comparison. Studies were not eligible if the in-

terventions were from the same domain (eg, if the study compared 2 physical interventions). Study

quality was assessed used the Cochrane Back Review Group risk of bias criteria. The treatment effects

of physical, behavioral/psychologically informed, and combined interventions were assessed using

meta-analyses. Twenty-four studies were included. No clinically significant differences were found

for pain and disability between physical, behavioral/psychologically informed, and combined inter-

ventions. The simple categorization of interventions into physical, behavioral/psychologically

informed, and combined could be considered a limitation of this review, because these interventions

may not be easily differentiated to allow accurate comparisons to be made. Further work should

consider investigating whether tailoring rehabilitation to individual patients and their perceived

risk of chronicity, as seen in recent RCTs for low back pain, can enhance outcomes in NSCSP.

Perspective: In this systematic review of RCTs in NSCSP, only small differences in pain or disability

were observed between physical, behavioral/psychologically informed, and combined interventions.

ª 2016 by the American Pain Society

Key words: Nonspecific chronic spinal pain, physical, behavioral/psychological, combined, systematic

review.

One of the authors (M.O.K.) is supported by the Irish Research Council.The Irish Research Council were not involved in any part of the design,execution, or interpretation of this study.Three of the authors (K.O.S., W.D., P.O.S.) receive income from deliveringeducational courses on the use of specific combined approaches to man-aging spinal pain.The authors have no conflicts of interest to declare.Supplementary data accompanying this article are available online atwww.jpain.org and www.sciencedirect.com.

Address reprint requests to Mary O’Keeffe, BSc Physiotherapy, Depart-ment of Clinical Therapies, University of Limerick, Limerick, Ireland.E-mail: [email protected]

1526-5900/$36.00

ª 2016 by the American Pain Society

http://dx.doi.org/10.1016/j.jpain.2016.01.473

755

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N

Methods

756 The Journal of Pain Conservative Interventions for Nonspecific Chronic Spinal Pain

onspecific chronic spinal pain (NSCSP), particularlylow back pain (LBP) and neck pain (NP), remains acommon musculoskeletal disorder, resulting in a

significant personal, social, and economic burden.52,66,124

Although LBP and NP occupy different body regions,strong evidence exists that both are best consideredmultidimensional disorders, associated with a complexinteraction of contributory factors.58,87,103,105 Althougha plethora of interventions for NSCSP have been tested,heralding similar short-term outcomes,5,29,108 positivelong-term outcomes are infrequent. One explanationfor this relative ineffectiveness is the fact thatmany inter-ventions used are unidimensional, either focusing onphysical or behavioral/psychological factors, rather thancombining/tailoring these approaches to the individualneeds of the person with NSCSP.71,87 However, researchon the tailoring of care to date has mixed results, withsome studies showing encouraging findings,33,49 andothers not showing an effect.46 Considering the increasein the number of randomized controlled trials (RCTs) con-ducted onNSCSP there is a need for a systematic review todetermine which of these interventions has the greatestlevel of evidence.Physical factors that have been described among peo-

ple with NSCSP include maladaptive postures,26,130

movement patterns associated with altered levels ofmuscle activity,31,50 altered body perception,14,98 painbehaviors (eg, propping, breath-holding, bracing),75 andmuscular deconditioning.27,131 Behavioral/psychologicalfactors that have been described among people withNSCSP include fear,83,84 maladaptive beliefs,16,89

catastrophic thoughts,13,126 hypervigilance,88,128 anxiety,depression, stress,17,119 poor pacing, maladaptive copingstrategies,1,18 poor self-efficacy,109,129 physicalinactivity,39 and sleep problems.60 Therefore, currentrehabilitation for NSCSP comprises a range of interven-tions, primarily aimed at addressing physical, behavioral/psychological, or both of these factors.Physical interventions aim to enhance physical capacity

by using methods such as exercise, manual therapy, andergonomics.115 Despite many treatment options,numerous trials have shown that most physical interven-tions have similar modest levels of effectiveness in thetreatment of NSCSP.7,54,68,74,125 Furthermore, positiveresults for these physical interventions are most evidentwhen compared with minimal interventions, placebo,or waiting list control groups.9,38,45,61,78

Behavioral/psychologically informed interventions useeducational, cognitive, or psychological strategies toenhance behaviors, cognitions, or moods. These includerelaxation, biofeedback, cognitive-behavioral therapy,mindfulness-based stress reduction, as well as accep-tance and commitment therapy.51 Similar to the evi-dence for physical interventions, no behavioral/psychologically informed intervention has been foundto be superior to another.47,107,117,118 In addition,positive effects are once again most evident whencompared with minimal interventions, placebo, orwaiting list control groups.21,30,47,86,106,127

Combined interventions aim to target physicaland behavioral/psychological factors contributing to a

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patients’ pain. These include multidisciplinary team(MDT) pain management programs, functional restora-tion programs, yoga, graded activity, graded exposure,behaviorally-informed physiotherapy, or exercise com-bined with behavioral/psychologically informed inter-ventions such as relaxation or cognitive-behavioraltherapy.21,43,93,101,114 Combined interventions havebeen shown to be superior to minimal interventions,placebo, or waiting list control groups.56,79,90,112 Onereview56 conducted in chronic low back pain (CLBP) re-ported that MDT programs were more effective thanphysical treatments and concluded that cost and re-sources should be considered when deciding whethersuch interventions are worthwhile, considering thesmall size of the effect. This review56 also suggeststhat combined interventions should be reserved formore complex patients.Although it seems clear that physical, behavioral/psy-

chologically informed, and combined interventions aresuperior to minimal or no treatment,6,59,86 it remainsunclear whether either is superior to the other.Whereas 1 systematic review56 has compared the effec-tiveness of physical and multidisciplinary programs inpeople with CLBP, no systematic review has comparedthe effectiveness of the current interventions in anNSCSP population. Furthermore, no review hascompared the effectiveness of behavioral and combinedtreatments in this population. Therefore, the primaryobjective of this systematic review was to assess thecomparative effectiveness of physical, behavioral/psy-chologically informed, and combined interventions onpain and disability in patients with NSCSP.

-

Literature Search StrategyThe review was registered on the PROSPERO database

(Registration number CRD42013005757) and has been re-ported in accordance with the Preferred Reporting Itemsfor Systematic Reviews and Meta-Analyses statement.80

All relevant RCTs and cluster randomized trials meetingthe inclusion criteria (see the section on Inclusion andExclusion Criteria) were identified by the following:� A computer-aided search of the Academic SearchComplete, MedLine, Cinahl, SPORTDiscus, Biomed-ical Reference Collection, AMED, PsycINFO, PsycAR-TICLES, Embase, and Web of Science databasesfrom the period of inception to January 2013 usingthe search strategy recommended by the CochraneBack Review Group (CBRG; Fig 1). The search wasrestricted to include trials that involved humansand were published in English.

� Scanning the reference lists of previous systematicreviews and included studies for further references.

Two independent reviewers (M.O.K. andK.O.S.) conducted the electronic searches. The strategyhad 4 components, which were combined: 1) physical/behavioral/psychological/combined intervention, 2) spi-nal pain, 3) chronic, and 4) RCT (see SupplementaryAppendix A for details).

VA Medical Center Boston October 19, 2016.n. Copyright ©2016. Elsevier Inc. All rights reserved.

Search Strategy

Academic Search Complete: (n = 3,270)

MEDLINE: (n = 2,196)

CINAHL: (n = 1,440)

SPORTDiscus: (n = 1,364)

Biomedical Reference Collection: (n = 925)

AMED: (n = 441)

PsycINFO: (n = 284)

PsycARTICLES: (n = 77)

EMBASE: (n = 471)

Web of Science: (n = 2,252)

Potentially relevant articles identified and screenedfor retrieval (n = 12,720)

Excluded after screening of title and abstract: (n = 7,727)

Excluded due to duplication: (n = 4,746)

Potentially appropriate articles forretrieval (n = 247)

Reasons for exclusion (n = 223)

1. Lack of “active” control group

2. Minimal intervention for controlgroup

3. Lack of psychological component

4. Interventions from the samedomain (physical, behavioral,combined)

5. Duration of symptoms <3 months

6. Follow-up <3 months

Finalized included articles (n = 24)

Figure 1. Literature search flowchart.

O’Keeffe et al The Journal of Pain 757

Inclusion and Exclusion Criteria

Study Design

Only published reports of completed RCTs published inpeer-reviewed journals were included. Studies wererequired to have a minimum follow-up period of12 weeks after completion of treatment.

Population

Studies including participants with NSCSP (neck,thoracic, low back, or pelvic) >12 weeks duration and be-tween 18 and 65 years of age, were eligible. Participants

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with previous spinal surgery (>6months previously) wereeligible. Studies that involved participants with specificpathologies/conditions (eg, pregnancy, fibromyalgia,rheumatoid arthritis, ankylosing spondylitis, stenosis,psoriatic arthritis, lupus erythematosus, Scheuermanndisease, spondylolisthesis, or ‘‘red flag’’ disorders (eg, spi-nal cord compression/cauda equina, spinal cord injury,neoplasm, fracture) were excluded.

Interventions

Studies were required to involve a head-to-head com-parison between 2 of our 3 chosen categories of interest

- VA Medical Center Boston October 19, 2016.on. Copyright ©2016. Elsevier Inc. All rights reserved.

(ie, active physical or behavioral/psychologically informedor combined interventions). Therefore, studies that had‘‘no treatment,’’ ‘‘waiting list,’’ ‘‘treatment as usual,’’ orusual medications as a control group were excluded. Ifhowever, ‘‘usual treatment’’ involved some form of ther-apy other than general practitioner/medications (eg,usual outpatient physiotherapy/pain clinic rehabilita-tion), a study was eligible for inclusion. Comparisonswith surgery, percutaneous procedures, or pharmacologywere excluded, because these were not deemed to beactive physical or behavioral/psychologically informed in-terventions. Studies deemed to have a minimalist controlgroup only (eg, short duration education sessions/semi-nars or merely provision of education or advice booklets)were excluded, on the basis of data highlighting thatphysical, behavioral/psychologically informed, and com-bined interventions have established superiority overminimalist intervention efforts.86,115 Studies were noteligible if the interventions were from the same domain(eg, if the study compared physical with physical).Education was defined as physical if it was pertaining tophysical aspects such as posture, anatomy, exercise, orbiomechanics. Education was defined as behavioral andor psychologically informed if it was pertaining tocognitive and psychological aspects such as beliefs, fear,stress, and relaxation. An intervention was only deemedto have an education component if it was a majoraspect of the intervention provided. For example, if anintervention had a large physical component and hadan educational leaflet that was behavior-focused, suchan educational leaflet was not adequate to be definedas behavioral. Therefore this intervention would still bedefined as physical, not combined.

Clinical Outcomes

Studies had to report results from 1 or more outcomemeasures in the domains of pain intensity/level of func-tional disability. Because research highlights that inter-ventions for NSCSP have similar outcomes immediatelyafter treatment,6 eligible studies were required to havedata at least 12weeks after the completion of treatment.Outcome data were then only abstracted for 3 time pe-riods: short-term follow-up (12 weeks to <6 months),medium-term follow-up (6 months to <12 months) andlong-term follow-up ($12 months).

Selection of Studies

A standard protocol was followed for study selectionand data abstraction.116 After the removal of duplicates,2 reviewers (M.O.K. and J.H.) independently screenedthe titles and abstracts from the articles found and dis-carded the irrelevant citations according to the selectioncriteria. If no abstract was available, or when it was notclear if the study should be included, full-text articleswere retrieved to determine inclusion or exclusion.Both reviewers kept a record of their reasons for the in-clusion or the exclusion of articles. The screened listswere compared between the 2 reviewers. To minimizethe risk of discarding studies incorrectly, articles thatwere initially chosen by only 1 reviewer were included

758 The Journal of Pain

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for the next stage of the review. The full-text version ofan article was obtained if the title and abstract seemedto fulfil the inclusion criteria or if the eligibility of thestudywas unclear. Any disagreements on study eligibilitywere resolved by discussion and a consensus meeting.Original study authors were e-mailed if clarificationwas needed on interventions provided.

Quality Assessment

Two reviewers (M.O.K. andM.C.) conducted the qualityassessment independently, using the risk of bias criteriaadvised by the CBRG37 (see Supplementary Appendix Bfor details), which consists of 12 items: random sequencegeneration, allocation concealment, blinding of partici-pants, blinding of personnel/care providers, blinding ofoutcome assessor, incomplete outcome data, selective re-porting, group similarity at baseline, cointerventions,intention-to-treat analysis, timing of outcome assess-ment, and any other bias not covered elsewhere. Eachitem was scored as ‘‘yes’’ if it fulfilled the criteria, as‘‘no’’ when there was a risk of bias, and as ‘‘unclear’’ ifthere was insufficient information. When it was unclearwhether a study did or did notmeet an item, or if no clearinformation regarding the itemwas stated, the author ofthe original study was contacted for clarification. A totalscore was calculated by using the number of items scoredas ‘‘yes.’’ Differences in the reviewers’ assessment of riskof bias were discussed during a consensus meeting. A to-tal score was computed, and high-quality was defined asfulfilling 6 or more (>50%) of the internal validity criteria(range, 0–12). The quality assessment scores for all studiesare shown in Table 1.

Data Extraction

Data regarding each study were extracted and cross-checked by 2 reviewers (M.O.K. and J.H.). The followingdata were extracted from the studies: 1) characteristicsof the studies: number of participants, sex, age, area ofpain, and inclusion/exclusion criteria; 2) characteristicsof the interventions: the type and content of interven-tions; 3) characteristics of the outcomes: pain anddisability outcome measures, length of follow-up; and4) results summary of each study. Similarities in theoutcome measures used, the subjects included, and theinterventions examined allowed for pooled analysis ofmost of the data.The data extracted from all studies are shown in

Table 2.

Data Analysis

Data analysis was performed by a statistician (H.P.). Thetreatment effects of physical interventions werecompared with 1) behavioral/psychologically informedinterventions, and 2) combined interventions usingmeta-analyses. Because only 1 study110 compared abehavioral/psychologically informed and combined inter-vention, no meta-analysis for this category wascompleted. The primary outcomes of interest were painintensity and functional disability. Pain intensity wasmeasuredusing a visual analogue scale (VAS) or a numeric

Conservative Interventions for Nonspecific Chronic Spinal Pain

A Medical Center Boston October 19, 2016.. Copyright ©2016. Elsevier Inc. All rights reserved.

Table 1. CBRG Risk of Bias Scores for Included Studies

REFERENCE 1 2 3 4 5 6 7 8 9 10 11 12 TOTAL

Christiansen et al19 1 1 � � � 1 1 1 1 1 1 1 9

Critchley et al23 1 1 � � � � 1 1 1 � 1 1 7

Dellve et al28 1 1 � � � 1 1 1 ? 1 1 1 8

Ferreira et al32 1 1 � � � 1 1 1 ? 1 1 1 8

Friedrich et al35 1 ? � � � � 1 1 ? � 1 1 5

Friedrich et al36 1 ? � � � � 1 1 ? 1 1 1 6

Gustavsson et al40 1 1 � � � ? 1 1 ? ? 1 1 6

Gustavsson et al42 1 1 � � � � 1 1 ? ? 1 1 6

Gustavsson et al41 1 1 � � � � 1 1 ? ? 1 1 6

Kankaanp€a€a et al57 1 ? � � � 1 1 1 ? 1 1 1 7

K€a€ap€a et al55 1 1 � � � 1 1 1 ? ? 1 1 7

Macedo et al67 1 1 � � � 1 1 1 ? 1 1 1 8

Machado et al70 1 1 � � � 1 1 1 ? 1 1 1 8

Mehling et al77 1 1 � � � 1 1 1 1 1 1 1 9

Monticone et al81 1 1 � � � 1 1 1 1 1 1 1 9

Rendant et al92 1 1 � � � 1 1 1 ? 1 1 1 8

Roche-Leboucher et al94 1 1 � � � � 1 1 ? ? ? 1 5

Sahin et al95 1 1 � � � 1 1 1 1 1 ? 1 8

Sherman et al97 1 1 � � � 1 1 1 1 ? 1 1 8

Smeets et al99 1 1 � � � 1 1 1 1 1 1 1 9

Sorensen et al102 1 1 � � � 1 1 1 � � 1 1 7

Turner et al110 1 ? � � ? � 1 1 ? 1 ? 1 5

Viljanen et al122 1 1 � � � 1 1 1 1 ? 1 1 8

Vonk et al123 1 1 � � � � 1 1 1 1 1 1 8

NOTE. 1, criterion fulfilled; �, criterion unfulfilled; ?, unclear if criterion fulfilled.


rating scale. The reported pain intensity scores were con-verted to a 10-point scale, where necessary, and a meandifference (MD)was computed. The analysis of functionaldisability required a standardized MD (SMD) to becomputed because studies used a number of differentmeasures to report disability including the Roland-Morris DisabilityQuestionnaire,Oswestry Disability Index,Pain and Disability Index, Hannover Activities of DailyLiving instrument, Neck Pain and Disability Index, LowBack Outcome Scale, and Neck Disability Index. Analyseswere carried out at 3 assessment points, with data fromstudies included according to the time closest to thefollowing intervals: 1) short-term follow-up (minimumof 12 weeks and <6 months), 2) medium-term follow-up(minimum of 6 months and <12 months, and 3) long-term follow-up (minimum of 12 months).A random-effects model was selected for all analyses a

priori, as recommended by the CBRG48 and heterogene-ity between treatment studies was reported using the I2

statistic. Substantial heterogeneity was determined us-ing the cutoff, I2$ 50%. In studies in whichmultiple con-trasts were examined (eg, physical intervention vsbehavioral/psychologically informed intervention 1 vsbehavioral/psychologically informed intervention 2),the sample size in the shared comparison was halved toavoid double-counting of participants in the analyses.In cases where standard deviations were not reported

at follow-up times, the baseline standard deviation wasused in the analysis.48 In studies where data were sum-marized using median and interquartile range values,the mean was approximated using the median and thewidth of the interquartile range was used as an approx-imation of 1.35 times the standard deviation.48 Pooled

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95% confidence intervals (CIs) were computed for MDand SMD and CIs excluding 0 were considered statisti-cally significant. Clinical relevance was determined usingthe following effect size classifications: 1) small: MD < 1[ie, <10% of the 10-mm VAS]; SMD (Cohen d) of 0.2; 2)medium: MD < 2, SMD (Cohen d) of .5; and 3) large:MD $ 2, SMD (Cohen d) of .8.20

The heterogeneity between studies was assessed visu-ally from the Forest plots, using formal Q-tests (c2 teststatistic and P value) and the I2 statistic. Subgroup ana-lyses were conducted by testing pooled differences inpain and disability between NP and LBP at each follow-up time. A sensitivity analysis was conducted to assess iflimiting the analysis to low risk of bias studies changedthe results. In this review, a negative effect size indicatesthat physical interventions are more beneficial than thecomparison. All analyseswere conducted in ReviewMan-ager (RevMan) software (version 5.2; The Nordic Co-chrane Centre, Copenhagen, Denmark).91

Results

Literature SearchStudy identification is summarized in Fig 1. The litera-

ture search of databases yielded 12,720 potentially rele-vant articles ofwhich 4,746 duplicateswere removed and7,974 titles and abstracts were scanned. Two hundredforty-seven full-text studies were retrieved with 223studies being excluded because they did not meet theeligibility criteria. Searching the reference lists of thesearticles did not yield any further articles. The major rea-sons for exclusion were lack of an ‘‘active’’ control group

VA Medical Center Boston October 19, 2016.n. Copyright ©2016. Elsevier Inc. All rights reserved.

Table 2. Overview of Characteristics of Included Studies

STUDY SAMPLE SIZE SEX

MEAN

AGE,YEARS

PAINCONDITION INTERVENTIONS

PAIN INTENSITYMEASURE

DISABILITY

MEASURE

LENGTH OF

FOLLOW-UP

INCLUSION

AND

EXCLUSION

CRITERIA RESULTS SUMMARY

INCLUDED IN

META-ANALYSIS

Christiansen

et al1960 38 F/22 M 47.7 CLBP 1. Exercise therapy and

education plus goalsetting, CBT and agoal pursuit strategy(combined)

2. Exercise therapy andeducation (physical)

NRS (0–10) Hannover ADL

instrument

(0–100)

3 Months LBP >6

months

No significant difference

in pain between

groups

Significant difference

observed in disability

between groups,

favoring group 1

U

Critchley et al23 212 136 F/76 M 44 CLBP 1. Individual physio-therapy (exercise,joint mobilization,massage; physical)

2. Spinal stabilizationclasses (physical)

3. Pain managementclasses (education,exercise, CBT; com-bined)

NRS (0–100) RMDQ (0–24) 6 Months;

12 months;

18 months

LBP >12

weeks


in pain and disability

between groups

U

Dellve et al28 73 73 F/0 M Chronic

NP

1. Exercise (muscularstrength training;physical)

2. Myofeedback (behav-ioral/or psycholog-ically informed)

NRS (0–10) 3 Months NP >12

months



between groups

U

Ferreira et al32 240 165 F/74 M 53.5 CLBP 1. Spinal manipulation(physical)

2. General exercise plusCBT (combined)

3. Motor control exer-cises with CBT (com-bined)

VAS (0–10) RMDQ (0–24) 6 Months;

12 months

LBP >3

months

No significant differences


between groups

U

Friedrich et al36 93 47 F/46 M 44 CLBP 1. Combined exerciseand motivation pro-gram (combined)

2. Exercise program(physical)

NRS (0–100) Low back

outcome scale

(0–75)

4 Months;

12 months

LBP >4

months


observed in pain and

disability, favoring

group 1

U

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Table 2. Continued


MEAN

AGE,YEARS



DISABILITY

MEASURE

LENGTH OF

FOLLOW-UP

INCLUSION

AND

EXCLUSION


INCLUDED IN

META-ANALYSIS

Friedrich et al35 93 47 F/46 M 44 CLBP 1. Combined exerciseand motivation pro-gram (combined)

2. Exercise program(physical)

NRS (0–100) Low back

outcome scale

(0–75)

5 Years LBP >4

months



disability between

groups, favoring

group 1, massive

dropout rate

X

Gustavsson and

von Koch4037 28 F/1 M 39.5 Chronic

NP

1. Pain and stress man-agement group inter-vention with appliedrelaxation (combined)

2. Individual physio-therapy (electro-therapy, exercise,massage, acupunc-ture, heat; physical)

NRS (0–10) NDI (0–50) 20 Weeks NP >3

months



between groups

U

Gustavsson et al42 156 139 F/17 M 45.7 Chronic

NP

1. A multicomponentpain and stress self-management groupintervention(combined)


NRS (0–10) NDI (0–100) 20 Weeks NP >3

months



between groups

U

Gustavsson et al41 156 139 F/17 M 45.7 Chronic

NP

1. A multicomponentpain and stress self-management groupintervention(combined)


NRS (0–10) NDI (0–100) 1 Year;

2 years

NP >3

months



between groups

U

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Table 2. Continued


MEAN

AGE,YEARS



DISABILITY

MEASURE

LENGTH OF

FOLLOW-UP

INCLUSION

AND

EXCLUSION


INCLUDED IN

META-ANALYSIS

K€a€ap€a et al55 120 120 F/0 M 46.3 CLBP 1. Multidisciplinarygroup rehabilitation(exercise, CBT, relaxa-tion, back school ed-ucation; combined)

2. Individual physio-therapy (exercise,massage, spinal trac-tion, mobilization, ul-trasound; physical)

NRS (0–10) ODI (0–100) 6 Months;

12 months;

2 years

LBP>3

months



between groups

U

Kankaanp€a€a

et al5759 22 F/37 M 39.6 CLBP 1. Exercise and behav-

ioral support (com-bined)

2. Individual physio-therapy (physical)

VAS (0–100) The Pain and

Disability Index

(0–70)

6 Month;

12 months

LBP >3

months


observed both in pain

and disability between

groups, favoring

group 1

U

Macedo et al67 172 102 F/70 M 49 CLBP 1. Graded activity (com-bined)

2. Motor control exer-cises (physical)

NRS (0–10) RMDQ (0–24) 6 Months;

12 months

LBP >3

months



between groups

U

Machado et al70 33 23 F/10 M 43.5 CLBP 1. Exercise (walking,stretching, strength-ening; physical)

2. Client-centered ther-apy (behavioral/psy-chologicallyinformed)

VAS (0–10) RMDQ (0–24) 6 Months LBP >3

months

At short-term follow-up,

significant difference

observed in disability

between groups,

favoring group 1.

At long-term, no

significant difference

in pain or disability

between groups

U

Mehling et al77 36 26 F/10 M 49.2 CLBP 1. Breath therapy(behavioral/psycho-logically informed)

2. Individual physio-therapy (exercise, ed-ucation, soft tissueand joint mobiliza-tion; physical)

VAS (0–10) RMDQ (0–24) 6 Months LBP >3

months



between groups

U

Monticone et al81 80 60 F/20 M 49.5 CLBP 1. Neck exercises withCBT (combined)

2. Neck exercises (phys-ical)

NRS (0–10) Neck Pain and

Disability Scale

(0–100)

12 Months NP >3

months



between groups

U

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Table 2. Continued


MEAN

AGE,YEARS



DISABILITY

MEASURE

LENGTH OF

FOLLOW-UP

INCLUSION

AND

EXCLUSION


INCLUDED IN

META-ANALYSIS

Rendant et al92 123 107 F/15 M 45.6 CLBP 1. Qigong (combined)2. Exercise therapy

(physical)

VAS (0–100) Neck Pain and

Disability Scale

(0–100)

3 Months;

6 months

NP >6

months



between groups

U

Roche-Leboucher

et al94132 46 F/86 M 39.8 CLBP 1. Functional restoration

(exercise, occupa-tional therapy, psy-chology; combined)

2. Individual physio-therapy (exercise,pain management;physical)

VAS (0–10) 12 months LBP >3

months



between groups

U

Sahin et al95 146 112 F/34 M 49.3 CLBP 1. Back school, with ex-ercise and TENS, US,and heat (combined)

2. Exercise with TENS,US, and heat (phys-ical)

VAS (0–10) ODI (0–100) 3 Months LBP >12

weeks



disability between

groups, favoring

group 1

U

Sherman et al97 228 146 F/82 M 48.4 CLBP 1. Yoga (combined)2. Stretching (physical)

NRS (0–10) RMDQ (0–23) 12 Weeks;

26 weeks

LBP >3

months



between groups

U

Smeets et al99 223 105 F/118 M 41.6 CLBP 1. Exercise (physical)2. Graded activity with

problem solving(combined)

3. Exercise with gradedactivity and problemsolving (combined)

VAS (0–100) RMDQ (0–24) 6 Months;

12 months

LBP >3

months



between groups

U

Sorensen et al102 207 108 F/99 M 39 CLBP 1. Exercise and educa-tional program (com-bined)

2. Individual exercisetherapy (physical)

NRS (0–10) RMDQ (0–23) 6 Months;

12 months

LBP >4

months



between groups

U

Turner et al110 96 46 F/50 M 44 CLBP 1. Group behavioraltherapy with aerobicexercise (combined)

2. Behavioral therapyonly (behavioral/psy-chologicallyinformed)

3. Aerobic exercise only(physical)

McGill pain

rating index

(0–78)

6 Months;

12 months

LBP >6

months



between groups

X

O’Keeffe

etal

TheJournalofPain

763

Dow

nloaded from C

linicalKey.com

at VISN

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ll rights reserved.

Table

2.Continued

STUDY

SAMPLE

SIZE

SEX

MEAN

AGE,

YEARS

PAIN

CONDITIO

NIN

TERVENTIO

NS

PAININ

TENSITY

MEASU

RE

DISABILITY

MEASU

RE

LENGTH

OF

FOLLOW-U

P

INCLU

SION

AND

EXCLU

SION

CRITERIA

RESU

LTSSU

MMARY

INCLU

DED

IN

META-A

NALY

SIS

Viljan

enet

al122

393

393F/0M

45

Chronic

NP

1.Dynam

icmuscle

training(physical)

2.Relaxation(beh

av-

ioral/p

sychologically

inform

ed)

3.Ordinaryactivity

(physical)

NRS(0–1

0)

NDI(0–8

0)

3Months;

6months

NP>12

weeks

Nosignificantdifference

inpainan

ddisab

ility

betweengroups

U

Vonket

al123

30

9F/21M

45.7

Chronic

NP

1.Beh

aviorgraded

ac-

tivity

(combined

)2.Individualphysio-

therap

y(exercise,

massage,

mobiliza-

tions;physical)

NRS(0–1

0)

NDI(0–1

00)

26Wee

ks;

12months

NP>3

months

Nosignificantdifference

inpainan

ddisab

ility

betweengroups

U

Abbreviations:F,female;

M,male;

CBT,cognitive-beh

avioraltherap

y;NRS,

numericratingscale;

ADL,activities

ofdailyliving;RMDQ,Roland-M

orrisDisab

ility

Questionnaire;NDI,NeckDisab

ility

Index;ODI,Osw

estryDisab

ility

Index;TENS,

tran

scutaneo

uselectrical

nerve

stim

ulation;US,

ultrasound.

NOTE.X,studyexcluded

from

meta-an

alysis;U,studyincluded

inmeta-an

alysis.



and comparison of interventions from the same domain(physical, behavioral/psychologically informed, or com-bined). Twenty-four articles met the selection cri-teria.19,23,28,32,35,36,40-42,55,57,67,70,72,77,81,92,94,95,97,99,102,122,123

Quality AssessmentThe quality assessment scores are shown in Table 1.

Forty-eight study authors were e-mailed about theirstudies (about treatment content and quality) and toclarify whether they were eligible to be included in thisreview. Twenty-six authors replied. Studieswere excludedif no reply was received from the study author. Twenty-one studies included in this systematic review weredeemed to have a low risk of bias, with 4 studies19,77,81,99

scoring the highest (9 of 12). Three studies35,94,110 weredeemed to have a high risk of bias (<6 of 12). Commonmethodological limitations identified across studiesincluded lack of information on cointerventions,blinding, and compliance to treatment.

PopulationThe sample sizes of the included studies ranged from

30 to 393 participants. The average age of the partici-pants in these studies ranged from 39 to 53.5 years. Eigh-teen studies investigated patients with CLBP, and 6studies investigated participants with chronic NP.

Intervention CharacteristicsThe content and characteristics of the various physical,

behavioral/psychologically informed, and combined in-terventions are shown in Table 2. Five studies comparedphysical and behavioral/psychologically informed inter-ventions. Twenty studies compared physical and com-bined interventions. Only 1 study compared abehavioral/psychologically informed and combinedintervention.110

Clinical Outcome MeasuresAll studies reported results for pain intensity.

Twenty-three of the 24 studies used the VAS ornumeric rating scale to measure pain intensity, and 1study110 used the McGill Pain Rating Index. Threestudies did not report results for functionaldisability.28,94,110 The Oswestry Disability Index, NeckDisability Index, and Roland-Morris Disability Ques-tionnaire were the commonly adopted functionaldisability assessment scales, being used in 18 studies.One study used the Pain and Disability Index.57

Another study used the Hannover Activities of DailyLiving instrument.19 Furthermore, 2 studies chose theLow Back Outcome Scale35,36 and another 2 used theNeck Pain and Disability Scale.81,92

Meta-AnalysisTwenty-two of the 24 studies were included in the

meta-analysis of pain and disability. Therefore, 2studies35,110 were excluded from the analysis. The firststudy35 was a 5-year follow-up and was excluded from


- VA Medical Center Boston October 19, 2016.n. Copyright ©2016. Elsevier Inc. All rights reserved.

Figure 2. Effect of physical versus behavioral/psychologically informed interventions on pain.


themeta-analysis because the remaining studies all had along-term follow-up of a maximum of 24 months. Thesecond study110 used an outcome measure (McGill PainRating Index) that was too heterogeneous to be pooledwith the remaining studies in the physical versus behav-ioral/psychological and physical versus combined ana-lyses. This was also the only study110 to compare abehavioral and combined intervention meaning thatpooling of data was not possible and consequently thereis no comparison between behavioral/psychologicallyinformed versus combined interventions in the meta-analysis. These 2 studies35,110 also had a high risk ofbias (<6 of 12).

Subgroup and Sensitivity AnalysesSubgroup analyses were conducted by testing pooled

differences in pain and disability between NP and LBPstudies at each follow-up time. No significant differenceswere found between subgroups in the effects on pain ordisability (P > .05).A sensitivity analysis was conducted by limiting to

studies with a low risk of bias. Twenty-one studies wereincluded in the sensitivity analysis after those at highrisk of bias35,94,110 were excluded. No significantdifferences between interventions in the effects onpain and disability were found (P > .05).

Effects of Physical Versus Behavioral/Psychologically Informed Interventionson Pain IntensityNo statistically significant difference was found for

pain intensity between the physical and behavioral/psy-chologically informed groups at short-term (2 studies,n = 272; MD = .03; 95% [CI], �.52 to .57; I2 = 0%) and atmedium-term (3 studies, n = 278; MD = �.50; 95% CI,�1.38 to 0.38; I2 = 19%) follow-up (Fig 2).Because only 1 study122 measured pain in the long-term

in the physical versus behavioral/psychologically informed


groups, there is no long-term plot in this section ofmeta-analysis. This study found no statistically significantdifference for pain intensity between the physical andbehavioral/psychologically informed groups.

Effects of Physical Versus Behavioral/Psychologically Informed Interventionson DisabilityNo statisitically significant difference was found for

disability between the physical and behavioral/psycho-logically informed groups at short-term (2 studies,n = 272; MD = .02; 95% CI, �0.23 to 0.27; I2 = 4%) andat medium-term (3 studies, n = 278; SMD = �.05; 95%CI, �.29 to .18; I2 = 0%) follow-up (Fig 3).Because only 1 study122 measured disability in the long-

term in the physical versus behavioral/psychologicallyinformed groups, there is no long-termplot in this sectionof meta-analysis. This study found no statistically signifi-cant difference for disability between the physical andbehavioral/psychologically informed groups.

Effect of Physical Versus CombinedInterventions on Pain IntensityA statistically significant difference was found for pain

between groups (favoring the combined group) at short-term (5 studies, n = 529; MD = .52; 95% CI, .16–.88;I2 = 4%) and at long-term (15 studies, n = 1,453;MD = .47; 95% CI, .13–.81; I2 = 35%) follow-up (Fig 4).No statistically significant difference was found for

pain between physical and combined interventions atmedium-term (15 studies, n = 1,535; MD = .14; 95% CI,�.10 to .39; I2 = 0%) follow-up (Fig 4).

Effect of Physical Versus CombinedInterventions on DisabilityA statistically significant difference was found for

disability between groups (favoring the combined


Figure 3. Effect of physical versus behavioral/psychologically informed interventions on disability.


group) at short-term (5 studies, n = 529; SMD = .27; 95%CI, .01–.54; I2 = 56%) and at long-term (13 studies,n = 1,189; SMD = .25; 95% CI, .07–.43; I2 = 54%) follow-up (Fig 5).No statistically significant difference was found for

disability between physical and combined interventionsat medium-term follow-up (13 studies, n = 1,206;SMD = .12; 95% CI, �.06 to .30; I2 = 55%; Fig 5).

Effect of Behavioral/PsychologicallyInformed Versus CombinedInterventions on Pain Intensity andDisabilityBecause only 1 study110 compared a behavioral/

psychologically informed and combined intervention,no meta-analysis for this category was completed. Nostatistically significant differences were found for painand disability between the behavioral/psychologicallyinformed intervention and combined groups.

DiscussionThis systematic review and meta-analysis investigated

the comparative effectiveness of physical, behavioral/psy-chologically informed, and combined interventions forpain and disability in NSCSP populations. No statisticallysignificant differences were found for pain and disabilitybetween physical and behavioral/psychologicallyinformedgroups in themedium- and long-term. No statis-tically significant differences were found for pain anddisability in the single study110 comparing behavioral/psy-chologically informed and combined interventions.Although a small statistically significant difference wasfound for pain and disability between the physical andcombined group, favoring the combined group, this dif-ferencewas small.12 This suggests that there are only smalldifferences between physical, behavioral/psychologicallyinformed, and combined interventions for reducing painand disability in NSCSP patients.Although it may appear surprising that these very

different interventions show such similar effects for


NSCSP, it is clear that simply combining them offersonly a small additional benefit. Consequently, choosingthe most cost-efficient rehabilitation choice, which isacceptable to patients and also feasible for a healthcare service to provide, should be considered. Similarly,Kamper et al56 reported that combined multidisciplinaryprograms are significantly more effective than physicaltherapies for CLBP, but because of the small effect, thedecision to choose a combined intervention should bebalanced against the time and resources available.One possible reason for the lack of differences is that

physical and behavioral/psychologically informed inter-ventions may in fact have similar mechanisms of effect.This is on the basis of trials showing that successful out-comes, even after a purely physical intervention, areoften mediated by changes in cognitive and psychologi-cal factors (eg, fear, catastrophizing, self-efficacy, be-liefs).2,72,82,100,113 Another possibility is that otherimportant ‘‘nonspecific factors’’ such as cliniciansupport, empathy, and ability to motivate andencourage and accommodate patients’ treatmentpreferences and expectations may be common to theseseemingly different interventions.34 This is supportedby data showing that a positive patient–therapist inter-action is linked to reduced pain and disability.44

It has been proposed that most RCTs have notadequately dealt with the multidimensional nature ofNSCSP.34,79,87,104 This is significant considering thegrowing evidence that NSCSP is associated with acomplex interplay of biopsychosocial factors. Thesemay include pathoanatomical factors (eg, disc prolapsewith radiculopathy, spondylolysis/spondylolisthesis,lateral recess/central stenosis),96 physical factors (eg,mal-adaptive postures and movement patterns, altered bodyperception, pain behaviors and deconditioning),62

cognitive factors (eg, unhelpful beliefs, catastrophizing,hypervigilance, maladaptive coping strategies, poor self-efficacy),64 psychological factors (eg, fear, anxiety,depression),8,11 lifestyle factors (eg, physical inactivity,sleep problems, chronic life stress),10,60,121

neurophysiological factors (eg, peripheral and centralnervous system sensitization),24,85 social factors (eg,


Figure 4. Effect of physical versus combined interventions on pain.


socioeconomic status, family, work, and culture),4,63 andgenetic factors.69 Even the ‘‘combined’’ treatment ap-proaches did not target this wide range of factors, forexample, commonly excluding factors such as sleep60,111

and life stress.64

Another potential reason for the similar effectivenessof these conservative interventions is that the interven-tions are insufficiently tailored to the needs of pa-tients.53,71,87 For example, 1 large RCT49 showed thatpeople with LBP could be categorized into 3 different


‘‘risk’’ profiles, each with different natural histories fortheir LBP. Consequently, some groups may benefit fromcombined physical and psychological support more thanothers, and identification of these patients could be facil-itated by using suitable screening measures.25,49,56,65

However, when the type (physical or combined) andamount of rehabilitation was matched to the perceivedneeds of each group, outcomes were improved. Theeffect sizes for this trial were small however, and in linewith the effect sizes shown in this review. Attempts to


Figure 5. Effect of physical versus combined interventions on disability.


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individualize rehabilitation in a biopsychosocial manneraccording to the needs of LBP patients, as opposed totargeting broad ‘‘risk’’ groups, resulted in significantlyless pain and disability in another recent RCT.120 However,because both of these RCTs offered combined rehabilita-tion in both intervention arms, they were ineligible forthis review. It is important, however, to acknowledgethat individualizing rehabilitation purely on the basis ofbiomedical and physical factors alone does not appearlikely to enhance outcomes.3,15,33,46 Therefore, althoughthe findings of this review show that simply combiningphysical and behavioral/psychologically informedinterventions does not increase effectiveness very much,there is a need for further studies investigating whethertailoring these rehabilitation options to the needs ofpatients can enhance effectiveness. The possibility thatNSCSP will remain highly resistant to treatment in somepatients, even when an individualized biopsychosocialapproach is used, cannot be discounted. Additionally,the similar effects seen across interventions may alsoreflect the use of outcome measures that are influencedby the types of bias present in the included studies.

Future Research and Clinical ImplicationsBecause of the strong evidence that NSCSP is associ-

ated with a complex interplay of biopsychosocial factors,the challenge is to determine whether individualizedcare on the basis of targeting these factors offers greaterbenefits over other current approaches.49,53,76,87 FutureRCTs should also incorporate mediation analysis toinvestigate and better understand particular patientprofiles who respond best to specific treatmentapproaches, and the mechanisms underlying differentinterventions,73,100 including consideration of the roleof ‘‘nonspecific’’ factors such as therapeutic alliance,and the use of qualitative approaches where necessary.

Strength and LimitationsTo our knowledge, this is the first comprehensive sys-

tematic review and meta-analysis to compare the effec-tiveness of physical, behavioral/psychologicallyinformed, and combined interventions in NSCSP. Moststudies that were included were of high methodolog-ical quality. Kamper et al56 published a systematic re-view during the completion of the current review,investigating physical versus combined interventionsin CLBP. From this perspective, our physical versuscombined comparison is a repeat (and therefore confir-mation) of the comparison by Kamper et al. The currentreview had also initially aimed to investigate behav-ioral/psychologically informed versus combinedcomparisons, but because only 1 study was found, ameta-analysis could not be completed on this compari-son. Furthermore, our review expanded on the reviewby Kamper et al by including NSCSP, not just CLBP, andinvestigated physical versus behavioral/psychologicallyinformed interventions, as well as physical versus com-bined interventions. However, there are significant is-sues in our review methodology which need to beacknowledged. Only RCTs published in English were

O’Keeffe et al


included, therefore potentially relevant studies in otherlanguages may have been excluded. In addition,searches were limited to published studies only, whichintroduced a risk of publication bias. Not all studiescould be included in the meta-analysis. For example,there was no plot showing the effect of behavioralversus combined rehabilitation because there was only1 studying comparing these interventions.110 This mayindicate a preference for always including a physicalcomponent in interventions instead of a behavioral/psy-chological component, possibly showing the domi-nance of the biomedical model in practice and thatmost treatments assume peripheral nocioception is theprimary driver of NSCSP. Furthermore, review proce-dures have evolved since the authors of this report sub-mitted the original review protocol. The authors of thisreport used a summary score out of 12 and specific cut-off values to distinguish high- from low-quality studies.Using this systemmeans that a study that fulfils any 6 ofthe 12 criteria is deemed high-quality. This approach haslimitations, however, becausemeta-epidemiological ev-idence suggests that failure on any 1 of the 12 criteriamight alone explain a small positive effect on a subjec-tive self-reported outcome. Some study authors did notreply to e-mails regarding their study interventions andmethodology. This may have resulted in errors of eligi-bility and risk of bias rating. Furthermore, althoughthis approach was previously recommended by Co-chrane, it is no longer advocated for risk of bias assess-ment. Also, in this review all the primary outcomemeasures were subjective self-report scales (pain ordisability) and the primary outcome data assessorswere the patients themselves—hence high risk of biasfor both of these considerations for all studies. The au-thors of this report did not award a point for blindedassessment. This might be considered strict becausethe scoring is an arbitrary process, and it is simply notpossible to get this point in studies of pain.A further significant limitation of this review is the

method used to group interventions; physical versusbehavioral/psychologically informed versus combined.The authors chose these groupings on the basis of theirinterpretation of the biopsychosocial model and theirexperience of different interventions. Therefore, thegroupings are purely subjective, creating major diffi-culties for interpretation of the data. In reality, interven-tions cannot be easily differentiated and separated,which introduces a lot of heterogeneity, making mean-ingful comparisons very difficult.Only studies featuring an active control group were

included, whichmay have contributed to the small effectsizes. This was deemed appropriate, however, because ofthe consistent evidence that physical, behavioral/psycho-logically informed, and combined interventions are su-perior to minimal interventions, placebo, or waiting listcontrol groups.5,108 The meta-analysis pooled the resultsfor NP and LBP together. It could be argued that the re-sults may have been different if plots were formed sepa-rately. However, the subgroup and sensitivity analysesperformed showed no difference, further supportingthe contention that LBP and NP both involve an

The Journal of Pain 769


interaction of multiple factors across the biopsychosocialspectrum.85,87,103

ConclusionsNo clinically significant differences were found for

pain and disability between physical, behavioral/psycho-logically informed, and combined interventions forNSCSP. As a result, choosing the most cost-efficient,feasible rehabilitation option may be reasonable.


References

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Further work may be needed to investigate whethertailoring rehabilitation to the needs of individual pa-tients, which has been seen in recent RCTs for LBP, canenhance outcomes in NSCSP.

Supplementary DataSupplementary data related to this article can be

found at http://dx.doi.org/10.1016/j.jpain.2016.01.473.


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