Behavioural treatment for chronic low‐back pain

Nicholas Henschke; Raymond WJG Ostelo; Maurits W van Tulder; Johan WS Vlaeyen; Stephen Morley; Willem JJ Assendelft; Chris J Main

doi:10.1002/14651858.CD002014.pub3

. 2010 Jul 7;2010(7):CD002014. doi: 10.1002/14651858.CD002014.pub3

Behavioural treatment for chronic low‐back pain

Nicholas Henschke ^1,^✉, Raymond WJG Ostelo ², Maurits W van Tulder ³, Johan WS Vlaeyen ⁴, Stephen Morley ⁵, Willem JJ Assendelft ⁶, Chris J Main ⁷

Editor: Cochrane Back and Neck Group

PMCID: PMC7065591 PMID: 20614428

Abstract

Background

Behavioural treatment is commonly used in the management of chronic low‐back pain (CLBP) to reduce disability through modification of maladaptive pain behaviours and cognitive processes. Three behavioural approaches are generally distinguished: operant, cognitive, and respondent; but are often combined as a treatment package.

Objectives

To determine the effects of behavioural therapy for CLBP and the most effective behavioural approach.

Search methods

The Cochrane Back Review Group Trials Register, CENTRAL, MEDLINE, EMBASE, and PsycINFO were searched up to February 2009. Reference lists and citations of identified trials and relevant systematic reviews were screened.

Selection criteria

Randomised trials on behavioural treatments for non‐specific CLBP were included.

Data collection and analysis

Two review authors independently assessed the risk of bias in each study and extracted the data. If sufficient homogeneity existed among studies in the pre‐defined comparisons, a meta‐analysis was performed. We determined the quality of the evidence for each comparison with the GRADE approach.

Main results

We included 30 randomised trials (3438 participants) in this review, up 11 from the previous version. Fourteen trials (47%) had low risk of bias. For most comparisons, there was only low or very low quality evidence to support the results. There was moderate quality evidence that:

i) operant therapy was more effective than waiting list (SMD ‐0.43; 95%CI ‐0.75 to ‐0.11) for short‐term pain relief;

ii) little or no difference exists between operant, cognitive, or combined behavioural therapy for short‐ to intermediate‐term pain relief;

iii) behavioural treatment was more effective than usual care for short‐term pain relief (MD ‐5.18; 95%CI ‐9.79 to ‐0.57), but there were no differences in the intermediate‐ to long‐term, or on functional status;

iv) there was little or no difference between behavioural treatment and group exercise for pain relief or depressive symptoms over the intermediate‐ to long‐term;

v) adding behavioural therapy to inpatient rehabilitation was no more effective than inpatient rehabilitation alone.

Authors' conclusions

For patients with CLBP, there is moderate quality evidence that in the short‐term, operant therapy is more effective than waiting list and behavioural therapy is more effective than usual care for pain relief, but no specific type of behavioural therapy is more effective than another. In the intermediate‐ to long‐term, there is little or no difference between behavioural therapy and group exercises for pain or depressive symptoms. Further research is likely to have an important impact on our confidence in the estimates of effect and may change the estimates.

Plain language summary

Behavioural treatment for chronic low‐back pain

Low‐back pain is a major health and economical problem that affects populations around the world. Chronic low‐back pain, in particular, is a major cause of medical expenses, work absenteeism, and disability. Current management of chronic low‐back pain includes a range of different treatments such as medication, exercise, and behavioural therapy. Research has shown that social roles and psychological factors have a role in the course of chronic low‐back pain.

This review of 30 studies (3438 participants) evaluated three behavioural therapies for chronic low‐back pain: (i) operant (which acknowledges that external factors associated with pain can reinforce it), (ii) cognitive (dealing with thoughts, feelings, beliefs, or a combination of the three, that trigger the pain), (iii) respondent (interrupts muscle tension with progressive relaxation techniques or biofeedback of muscle activity).

For pain relief, there was moderate quality evidence that:

(i) operant therapy was more effective than waiting list controls in the short‐term,

(ii) there was little or no difference between operant therapy, cognitive therapy; or a combination of behavioural therapies in the short‐ or intermediate‐term, and

(iii) behavioural treatment was more effective than usual care (which usually consists of physical therapy, back school and/or medical treatments) in the short‐term.

Over a longer term, there was little or no difference between behavioural treatment and group exercise for pain relief or reduced depressive symptoms. The addition of behavioural therapy to inpatient rehabilitation did not appear to increase the effect of inpatient rehabilitation alone.

For most of the other comparisons, there was only low or very low quality evidence, which was based on the results of only two or three small trials. There were only a few studies which provided information on the effect of behavioural treatment on functional disability or return to work.

Further research is very likely to have an important impact on the results and our confidence in them.

Summary of findings

Summary of findings for the main comparison. Summary of findings: Behavioural treatment versus waiting list control.

Behavioural treatment compared with waiting list control for chronic low‐back pain
Patient or population: adults with chronic low‐back pain Settings: primary and secondary health care centres Intervention: behavioural treatment (respondent, cognitive, and operant therapy, or a combination) Comparison: waiting list control
Outcomes	Illustrative means (95% CI)		No of Participants   (studies)	Quality of the evidence   (GRADE)	Comments
	Control group	Intervention group
	Waiting list control	Respondent therapy (progressive relaxation)
Pain intensity VAS scale (0‐100) short‐term follow‐up	The mean pain intensity ranged across control groups from   44.4 to 77.0 points	The mean pain intensity in the intervention groups was 19.77 points lower (34.34 to 5.2 lower)	74   [3 studies]	++OO   low^1,3
Functional status (generic) various scales short‐term follow‐up		The mean generic functional status in the intervention groups was 0.88 standard deviations lower (1.36 to 0.39 lower)	74   [3 studies]	++OO   low^1,3	SMD ‐0.88 (‐1.36 to ‐0.39)
Depression Beck Depression Inventory (0‐63) short‐term follow‐up	The mean depression ranged across control groups from   7.2 to 22.4 points	The mean depression in the intervention groups was 6.8 points lower (19.73 lower to 6.12 higher)	58   [2 studies]	+OOO   very low^1,2,3
	Waiting list control	Respondent therapy (EMG biofeedback)
Pain intensity various scales short‐term follow‐up		The mean pain intensity in the intervention groups was 0.8 standard deviations lower (1.32 to 0.28 lower)	64   [3 studies]	++OO   low^1,3	SMD ‐0.8 (‐1.32 to ‐0.28)
Functional status (generic) various scales short‐term follow‐up		The mean functional status in the intervention groups was 0.17 standard deviations lower (1.56 lower to 1.22 higher)	44   [2 studies]	+OOO   very low^1,2,3	SMD ‐0.17 (‐1.56 to 1.22)
	Waiting list control	Operant therapy
Pain intensity various scales short‐term follow‐up		The mean pain intensity in the intervention groups was 0.43 standard deviations lower (0.75 to 0.11 lower)	153   [3 studies]	+++O   moderate³	SMD ‐0.43 (‐0.75 to ‐0.11)
Functional status (generic) Sickness Impact Profile (0‐136) short‐term follow‐up	The mean generic functional status ranged across control groups from   5.4 to 5.7 points	The mean functional status in the intervention groups was 1.18 points lower (3.53 lower to 1.18 higher)	87   [2 studies]	++OO   low^1,3
Depression various scales short‐term follow‐up		The mean depression in the intervention groups was 0.11 standard deviations lower (0.67 lower to 0.44 higher)	103   [2 studies]	++OO   low^1,3	SMD ‐0.11 (‐0.67 to 0.44)
	Waiting list control	Cognitive therapy
Pain intensity various scales short‐term follow‐up		The mean pain intensity in the intervention groups was 0.27 standard deviations lower (0.75 lower to 0.22 higher)	68   [2 studies]	++OO   low^1,3	SMD ‐0.27 (‐0.75 to 0.22)
Functional status (generic) various scales short‐term follow‐up		The mean functional status in the intervention groups was 0.15 standard deviations lower (0.64 lower to 0.33 higher)	68   [2 studies]	++OO   low^1,3	SMD ‐0.15 (‐0.64 to 0.33)
	Waiting list control	Combined behavioural therapy
Pain intensity various scales short‐term follow‐up		The mean pain intensity in the intervention groups was 0.60 standard deviations lower (0.97 to 0.22 lower)	239   [5 studies]	++OO   low^1,3	SMD ‐0.60 (‐0.97 to ‐0.22)
Functional status (generic) various scales short‐term follow‐up		The mean functional status in the intervention groups was 0.37 standard deviations lower (0.87 lower to 0.13 higher)	134   [4 studies]	++OO   low^1,3	SMD ‐0.37 (‐0.87 to 0.13)
Depression Beck Depression Inventory (0‐63) short‐term follow‐up	The mean depression ranged across control groups from   7.2 to 22.4 points	The mean depression in the intervention groups was 1.92 points lower (6.16 lower to 2.32 higher)	194   [4 studies]	+OOO   very low^1,2,3
CI: Confidence interval
GRADE Working Group grades of evidence   High quality: Further research is very unlikely to change our confidence in the estimate of effect.   Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.   Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.   Very low quality: We are very uncertain about the estimate.

Comparisons among behavioural treatments for chronic low‐back pain
Patient or population: adults with chronic low‐back pain Settings: primary and secondary health care centres Intervention: behavioural treatments (respondent, cognitive, and operant therapy, or a combination) Comparison: behavioural treatments (respondent, cognitive, and operant therapy, or a combination)
Outcomes	Illustrative means (95% CI)		No of Participants   (studies)	Quality of the evidence   (GRADE)	Comments
	Control group	Intervention group
	Operant therapy	Cognitive therapy
Pain intensity various scales short‐term follow‐up		The mean pain intensity in the intervention groups was 0.41 standard deviations higher (0.63 lower to 1.45 higher)	93   [2 studies]	+++O   moderate³	SMD 0.41 (‐0.63 to 1.45)
Pain intensity various scales intermediate‐term follow‐up		The mean pain intensity in the intervention groups was 0.35 standard deviations higher (0.64 lower to 1.35 higher)	82   [2 studies]	+++O   moderate³	SMD 0.35 (‐0.64 to 1.35)
	Cognitive therapy	Combined behavioural therapy
Pain intensity various scales short‐term follow‐up		The mean pain intensity in the intervention groups was 0.24 standard deviations lower (1.36 lower to 0.87 higher)	61   [2 studies]	+OOO   very low^1,2,3	SMD ‐0.24 (‐1.36 to 0.87)
Pain intensity various scales intermediate‐term follow‐up		The mean pain intensity in the intervention groups was 0.3 standard deviations lower (2.59 lower to 1.98 higher)	44   [2 studies]	+OOO   very low^1,2,3	SMD ‐0.3 (‐2.59 to 1.98)
Pain intensity various scales long‐term follow‐up		The mean pain intensity in the intervention groups was 0.89 standard deviations lower (3.64 lower to 1.87 higher)	48   [2 studies]	+OOO   very low^1,2,3	SMD ‐0.89 (‐3.64 to 1.87)
Functional status (generic) Sickness Impact Profile (0‐136) short‐term follow‐up	The mean generic functional status ranged across control groups from   8.0 to 24.3 points	The mean functional status in the intervention groups was 2.01 points lower (10.02 lower to 5.99 higher)	61   [2 studies]	++OO   low^1,3
Functional status (generic) Sickness Impact Profile (0‐136) intermediate‐term follow‐up	The mean generic functional status ranged across control groups from   5.9 to 25.7 points	The mean functional status in the intervention groups was 3.2 points lower (16.44 lower to 10.04 higher)	47   [2 studies]	+OOO   very low^1,2,3
Functional status (generic) Sickness Impact Profile (0‐136) long‐term follow‐up	The mean generic functional status ranged across control groups from   5.3 to 20.8 points	The mean functional status in the intervention groups was 2.23 points lower (12.59 lower to 8.13 higher)	51   [2 studies]	+OOO   very low^1,2,3
Depression Beck Depression Inventory (0‐63) short‐term follow‐up	The mean depression ranged across control groups from   8.8 to 18.4 points	The mean depression in the intervention groups was 3.1 points lower (11.43 lower to 5.23 higher)	61   [2 studies]	+OOO   very low^1,2,3
Depression Beck Depression Inventory (0‐63) intermediate‐term follow‐up	The mean depression ranged across control groups from   9.4 to 16.1 points	The mean depression in the intervention groups was 4.66 points lower (10.94 lower to 1.61 higher)	47   [2 studies]	++OO   low^1,3
Depression Beck Depression Inventory (0‐63) long‐term follow‐up	The mean depression ranged across control groups from   6.5 to 12.8 points	The mean depression in the intervention groups was 0.64 points lower (4.61 lower to 3.32 higher)	51   [2 studies]	++OO   low^1,3
	Operant therapy	Combined behavioural therapy
Pain intensity various scales short‐term follow‐up		The mean pain intensity in the intervention groups was 0.15 standard deviations lower (0.46 lower to 0.16 higher)	161   [3 studies]	+++O   moderate³	SMD ‐0.15 (‐0.46 to 0.16)
Pain intensity various scales intermediate‐term follow‐up		The mean pain intensity in the intervention groups was 0.23 standard deviations lower (0.57 lower to 0.11 higher)	139   [3 studies]	+++O   moderate³	SMD ‐0.23 (‐0.57 to 0.11)
Pain intensity various scales long‐term follow‐up		The mean pain intensity in the intervention groups was 0.31 standard deviations lower (0.65 lower to 0.03 higher)	140   [3 studies]	+++O   moderate³	SMD ‐0.31 (‐0.65 to 0.03)
Functional status (generic) various scales short‐term follow‐up		The mean functional status in the intervention groups was 0.21 standard deviations higher (0.24 lower to 0.67 higher)	77   [2 studies]	++OO   low^1,3	SMD 0.21 (‐0.24 to 0.67)
Functional status (generic) various scales intermediate‐term follow‐up		The mean functional status in the intervention groups was 0.23 standard deviations lower (1.01 lower to 0.55 higher)	61   [2 studies]	++OO   low^1,3	SMD ‐0.23 (‐1.01 to 0.55)
Functional status (generic) various scales long‐term follow‐up		The mean functional status in the intervention groups was 0.50 standard deviations lower (1.56 lower to 0.56 higher)	66   [2 studies]	++OO   low^1,3	SMD ‐0.50 (‐1.56 to 0.56)
	Respondent therapy	Combined behavioural therapy
Pain intensity various scales short‐term follow‐up		The mean pain intensity in the intervention groups was 0.09 standard deviations higher (0.31 lower to 0.5 higher)	97   [3 studies]	++OO   low^1,3	SMD 0.09 (‐0.31 to 0.5)
Pain intensity various scales intermediate‐term follow‐up		The mean pain intensity in the intervention groups was 0.47 standard deviations higher (0.42 lower to 1.35 higher)	62   [2 studies]	++OO   low^1,3	SMD 0.47 (‐0.42 to 1.35)
Functional status (generic) various scales short‐term follow‐up		The mean functional status in the intervention groups was 0.38 standard deviations higher (0.02 lower to 0.78 higher)	97   [3 studies]	++OO   low^1,3	SMD 0.38 (‐0.02 to 0.78)
Functional status (generic) various scales intermediate‐term follow‐up		The mean functional status in the intervention groups was 0.13 standard deviations higher (0.81 lower to 1.07 higher)	62   [2 studies]	++OO   low^1,3	SMD 0.13 (‐0.81 to 1.07)
Depression Beck Depression Inventory (0‐63) short‐term follow‐up	The mean depression ranged across control groups from   6.2 to 8.1 points	The mean depression in the intervention groups was 2.89 points higher (0.55 to 5.24 higher)	97   [3 studies]	++OO   low^1,3
Depression Beck Depression Inventory (0‐63) intermediate‐term follow‐up	The mean depression ranged across control groups from   5.3 to 7.4 points	The mean depression in the intervention groups was 1.84 points lower (0.43 lower to 4.11 higher)	62   [2 studies]	++OO   low^1,3
CI: Confidence interval
GRADE Working Group grades of evidence   High quality: Further research is very unlikely to change our confidence in the estimate of effect.   Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.   Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.   Very low quality: We are very uncertain about the estimate.

Behavioural treatment compared with other treatments for chronic low‐back pain
Patient or population: adults with chronic low‐back pain Settings: primary or secondary health care settings Intervention: behavioural treatment (respondent, cognitive, and operant therapy, or a combination) Comparison: other chronic low‐back pain treatments (i.e. usual care, exercise, surgery)
Outcomes	Illustrative means (95% CI)		No of Participants   (studies)	Quality of the evidence   (GRADE)	Comments
	Control group	Intervention group
	Usual care	Behavioural treatment
Pain intensity VAS (0‐100) short‐term follow‐up	The mean pain intensity ranged across control groups from   48.9 to 53.0 points	The mean pain intensity in the intervention groups was 5.18 points lower (9.79 to 0.57 lower)	330   [2 studies]	+++O   moderate¹
Pain intensity VAS (0‐100) intermediate‐term follow‐up	The mean pain intensity ranged across control groups from   42.7 to 47.0 points	The mean pain intensity in the intervention groups was 4.29 points lower (9.28 lower to 0.69 higher)	319   [2 studies]	+++O   moderate¹
Functional status (back‐specific) various scales short‐term follow‐up		The mean back‐specific functional status in the intervention groups was 0.2 standard deviations lower (0.41 lower to 0.02 higher)	330   [2 studies]	+++O   moderate¹	SMD ‐0.2 (‐0.41 to 0.02)
Functional status (back‐specific) various scales intermediate‐term follow‐up		The mean back‐specific functional status in the intervention groups was 0.12 standard deviations lower (0.34 lower to 0.1 higher)	319   [2 studies]	+++O   moderate¹	SMD ‐0.12 (‐0.34 to 0.1)
	Exercise	Behavioural treatment
Pain intensity Pain Rating Index (0‐45) short‐term follow‐up	The mean pain intensity ranged across control groups from   17.5 to 17.8 points	The mean pain intensity in the intervention groups was 2.31 points lower (6.33 lower to 1.7 higher)	146   [2 studies]	++OO   low^1,2
Pain intensity Pain Rating Index (0‐45) intermediate‐term follow‐up	The mean pain intensity ranged across control groups from   15.2 to 15.7 points	The mean pain intensity in the intervention groups was 1.18 points higher (3.16 lower to 5.53 higher)	137   [2 studies]	+++O   moderate³
Pain intensity Pain Rating Index (0‐45) long‐term follow‐up	The mean pain intensity ranged across control groups from   14.9 to 16.6 points	The mean pain intensity in the intervention groups was 0.14 points higher (4.4 lower to 4.67 higher)	136   [2 studies]	+++O   moderate³
Depression various scales short‐term follow‐up		The mean depression in the intervention groups was 0.25 standard deviations higher (0.07 lower to 0.58 higher)	146   [2 studies]	++OO   low^1,3	SMD 0.25 (‐0.07 to 0.58)
Depression various scales intermediate‐term follow‐up		The mean depression in the intervention groups was 0.02 standard deviations higher (0.32 lower to 0.35 higher)	137   [2 studies]	+++O   moderate³	SMD 0.02 (‐0.32 to 0.35)
Depression various scales long‐term follow‐up		The mean depression in the intervention groups was 0.07 standard deviations higher (0.27 lower to 0.41 higher)	136   [2 studies]	+++O   moderate³	SMD 0.07 (‐0.27 to 0.41)
	Surgery	Behavioural treatment
Functional status (back specific) Oswestry Disability Index (0‐100) long‐term follow‐up	The mean back‐specific functional status ranged across control groups from   26.4 to 34.0 points	The mean back‐specific functional status in the intervention groups was 2.36 points higher (1.94 lower to 6.66 higher)	345   [2 studies]	++OO   low^1,4
CI: Confidence interval
GRADE Working Group grades of evidence   High quality: Further research is very unlikely to change our confidence in the estimate of effect.   Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.   Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.   Very low quality: We are very uncertain about the estimate.

Behavioural treatment in addition to other treatments for chronic low‐back pain
Patient or population: adults with chronic low‐back pain Settings: primary, secondary, or tertiary health care settings Intervention: behavioural treatment (respondent, cognitive, and operant therapy, or a combination) in addition to another treatment Comparison: the other treatment alone
Outcomes	Illustrative means (95% CI)		No of Participants   (studies)	Quality of the evidence   (GRADE)	Comments
	Control group	Intervention group
	Physiotherapy	Behavioural treatment + physiotherapy
Pain intensity 5‐point scale short‐term follow‐up	The mean pain intensity ranged across control groups from   2.7 to 3.0 points	The mean pain intensity in the intervention groups was 0.13 points lower (1.01 lower to 0.75 higher)	59   [2 studies]	++OO   low^1,2
Pain intensity 5‐point scale intermediate‐term follow‐up	The mean pain intensity ranged across control groups from   2.6 to 2.8 points	The mean pain intensity in the intervention groups was 0.11 points lower (0.67 lower to 0.44 higher)	45   [2 studies]	++OO   low^1,2
Depression Beck Depression Inventory (0‐63) short‐term follow‐up	The mean depression ranged across control groups from   12.1 to 16.4 points	The mean depression in the intervention groups was 1.56 points higher (1.71 lower to 4.83 higher)	59   [2 studies]	++OO   low^1,2
Depression Beck Depression Inventory (0‐63) intermediate‐term follow‐up	The mean depression ranged across control groups from   9.9 to 18.5 points	The mean depression in the intervention groups was 0.17 points higher (6.85 lower to 7.19 higher)	50   [2 studies]	++OO   low^1,2
Functional status (generic) Sickness Impact Profile (0‐136) short‐term follow‐up	The mean generic functional status ranged across control groups from   25.3 to 26.1 points	The mean generic functional status in the intervention groups was 6.26 points lower (12.71 to 0.19 lower)	59   [2 studies]	++OO   low^1,2
Functional status (generic) Sickness Impact Profile (0‐136) intermediate‐term follow‐up	The mean generic functional status ranged across control groups from   19.4 to 25.3 points	The mean generic functional status in the intervention groups was 0.93 points lower (6.71 lower to 4.84 higher)	51   [2 studies]	++OO   low^1,2
	Inpatient rehabilitation	Behavioural treatment + inpatient rehabilitation
Pain intensity various scales short‐term follow‐up		The mean pain intensity in the intervention groups was 0.14 standard deviations lower (0.34 lower to 0.05 higher)	405   [2 studies]	+++O   moderate¹	SMD ‐0.14 (‐0.34 to 0.05)
CI: Confidence interval
GRADE Working Group grades of evidence   High quality: Further research is very unlikely to change our confidence in the estimate of effect.   Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.   Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.   Very low quality: We are very uncertain about the estimate.

Study	Patients	Interventions	Relevant outcomes	Size of effect	Benefit/Harms
Altmaier 1992	Y	N	Y	N	?
Basler 1997	Y	Y	Y	N	?
Brox 2003	Y	Y	Y	N	?
Bush 1985	Y	Y	Y	?	?
Donaldson 1994	Y	Y	N	?	?
Fairbank 2005	Y	Y	N	N	?
Friedrich 1998	Y	Y	Y	?	?
Johnson 2007	Y	Y	Y	Y	?
Kole‐Snijders 1996	Y	Y	N	?	?
Leeuw 2008	Y	Y	Y	N	?
Linton 1989	N	Y	Y	?	?
Linton 2008	Y	N	Y	N	?
McCauley 1983	N	Y	Y	?	?
Newton‐John 1995	Y	Y	Y	?	?
Nicholas 1991	Y	Y	Y	N	?
Nicholas 1992	Y	Y	Y	N	?
Nouwen 1983	Y	Y	N	?	?
Poole 2007	Y	Y	Y	N	?
Rose 1997	N	N	Y	N	?
Schweikert 2006	Y	Y	Y	N	?
Smeets 2006	Y	Y	Y	Y	?
Strong 1998	Y	Y	Y	?	?
Stuckey 1986	N	Y	Y	?	?
Turner 1982	Y	Y	Y	?	?
Turner 1988	Y	Y	Y	?	?
Turner 1990	Y	Y	Y	?	?
Turner 1993	Y	Y	Y	?	?
van den Hout 2003	Y	Y	Y	?	?
van der Roer 2008	Y	Y	Y	?	Y
von Korff 2005	Y	Y	Y	N	?

Date	Event	Description
12 May 2010	New citation required and conclusions have changed	Reviewer comments incorporated into the manuscript. As a result, two RCTs from the original review were excluded (Bru 1994; Lindström 1992) as they did not meet the inclusion criteria and were not included in the analyses. Removing these RCTs and responding to these amendments did not change the conclusions of the updated review.
1 March 2009	New search has been performed	We included 11 new randomised controlled trials in this update. The risk of bias and clinical relevance of all included RCTs was assessed using the updated criterion of the Cochrane Back Review Group. The GRADE approach was incorporated and used to judge the quality of the evidence for a particular comparison.
30 October 2004	New citation required but conclusions have not changed	Neither of the changes listed below changed the conclusion of the original review dramatically. However, by disaggregating the different treatment effects, and analysing treatment effects of the various types of treatment separately, we tried to assess which type of behavioural treatment was most effective, which components of behavioural treatment are necessary, and which are superfluous.
18 October 2004	Feedback has been incorporated	See feedback section   Feedback received: 15/06/01   Response to feedback: 18/01/04
1 October 2003	New search has been performed	We included one additional randomised controlled study in this update. Another new element is that the original comparison of "all types of Cognitive Behavioural Treatment versus Waiting List Control, No treatment or Placebo" is now divided into various types of treatments (operant, cognitive and behavioural).

	Criteria for a judgment of "yes" for the sources of risk of bias
Method of randomisation	A random (unpredictable) assignment sequence. Examples of adequate methods are computer generated random sequence and pre‐ordered sealed envelopes. Methods of allocation using date of birth, social insurance/security number, date in which they are invited to participate in the study, or alternation will not be regarded as appropriate.
Concealment of treatment allocation	Assignment generated by an independent person not responsible for determining the eligibility of the patients. This person has no information about the persons included in the trial and has no influence on the assignment sequence or on the decision about eligibility of the patient.
Blinding of patients	The index and control groups are indistinguishable for the patients or the success of blinding was tested among the patients and it was successful.
Blinding of care providers	The index and control groups are indistinguishable for the care providers or the success of blinding was tested among the care providers and it was successful.
Blinding of outcome assessment	Item has a positive score if the outcome assessors are blinded regarding treatment allocation and the blinding is evaluated and adequate. If only self‐reported (by the patients) outcome measures are used the blinding procedure is adequate for outcome assessors if participant blinding is scored "yes".
Incomplete outcome data addressed (drop‐outs)	The number of participants who were included in the study but did not complete the observation period or were not included in the analysis must be described and reasons given. If the percentage of withdrawals and drop‐outs does not exceed 20% for short‐term follow‐up and 30% for long‐term follow‐up, and does not lead to substantial bias, a "yes" is scored.
Incomplete outcome data addressed (intention‐to‐treat analysis)	All randomised patients are reported/analysed in the group they were allocated to by randomisation for the most important moments of effect measurement (minus missing values) irrespective of non‐compliance and co‐interventions.
Free of selective reporting	The review author determines if all the results from all pre‐specified outcomes have been adequately reported in the published report of the trial. This information is either obtained by comparing the protocol and the report, or in the absence of the protocol, assessing that the published report includes enough information to make this judgment.
Similarity of baseline characteristics	Item has a positive score if the study groups are comparable at baseline for the most important prognostic factors (for example, demographic factors, duration and severity of complaints, and value of main outcome measures).
Co‐interventions avoided or similar	Item has a positive score if co‐interventions are avoided in the study design or are similar among the intervention groups.
Compliance	The reviewer determines if the compliance with the interventions is acceptable, based on the reported intensity, duration, number and frequency of sessions for both the index intervention and control intervention(s).
Timing of outcome assessments	Timing of outcome assessment should be identical for all intervention groups and for all important outcome assessments.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (short‐term)	3	74	Mean Difference (IV, Random, 95% CI)	‐19.77 [‐34.34, ‐5.20]
2 Functional status (short term)	3	74	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.88 [‐1.36, ‐0.39]
3 Depression (short term)	2	58	Mean Difference (IV, Random, 95% CI)	‐6.80 [‐19.73, 6.12]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (short term)	3	64	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.80 [‐1.32, ‐0.28]
2 Functional status (short term)	2	44	Std. Mean Difference (IV, Random, 95% CI)	‐0.17 [‐1.56, 1.22]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (short term)	3	153	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.43 [‐0.75, ‐0.11]
2 Functional status (short term)	2	87	Mean Difference (IV, Fixed, 95% CI)	‐1.18 [‐3.53, 1.18]
3 Depression (short term)	2	103	Std. Mean Difference (IV, Random, 95% CI)	‐0.11 [‐0.67, 0.44]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (short term)	2	68	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.27 [‐0.75, 0.22]
2 Functional status (short term)	2	68	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.15 [‐0.64, 0.33]

Methods	RCT; 'randomly assigned'
Participants	47 consecutive patients with CLBP, aged 18‐63 years, who were disabled and not working for at least 3 months. All patients were admitted to an inpatient LBP rehabilitation program, but excluded from the study if they were involved with litigation, or had pain relating to pregnancy or severe vertebral fracture. Two patients failed to complete the program and were not included in analysis.
Interventions	Behavioural treatment (I): standard 3‐week rehabilitation program with additional operant conditioning components, relaxation training, biofeedback, and cognitive‐behavioural coping skills training (N = 24). Reference treatment (R): standard 3‐week inpatient rehabilitation program: twice daily physical therapy, aerobic exercises, education, and vocational rehabilitation (N = 21).
Outcomes	Mean scores on McGill Pain Questionnaire pretreatment, at short‐term follow‐up (post‐treatment), and in the intermediate‐term (6 months): (I) 24.24, 23.76, and 22.66 vs. (R) 20.33, 18.05, and 18.19. No significant differences between groups on any outcome measures (pain intensity, pain interference, return to work, disability).
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	High risk	'randomly assigned'
Allocation concealment?	High risk	Inadequate
Blinding?   All outcomes ‐ patients?	High risk
Blinding?   All outcomes ‐ providers?	High risk
Blinding?   All outcomes ‐ outcome assessors?	High risk
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	Low risk
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	High risk
Free of selective reporting?	Low risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	High risk
Compliance acceptable?	Low risk
Timing outcome assessments similar?	Low risk

Methods	RCT; 'assignment of random numbers'.
Participants	94 patients with CLBP from three pain treatment centres who had not previously received behavioural treatment. 18 patients dropped out and were not included in analysis.
Interventions	Behavioural treatment (I): cognitive‐behavioural therapy (education, progressive muscle relaxation (Jacobson), modifying thoughts and feelings, pleasant activity scheduling, training of posture) plus medical treatment, groups of 5‐8 patients, 12 sessions of 150 min at weekly intervals (N = 36). Reference treatment (R): medical treatment (pain medication, nerve blocks, TENS, physical therapy) (N = 40).
Outcomes	Mean (SD) scores on pain intensity (NRS) pre‐ and post‐treatment (I) 4.6 (1.8), 4.1 (2.1) vs. (R) 4.0 (1.0), 4.2 (1.4); control over pain (I) 2.6 (1.9), 3.8 (2.5) vs. (R) 2.7 (1.7), 2.8 (1.8); (I) significantly more improved than (R). In behavioural domain: avoidance behaviour, pleasant activities, and catastrophising significantly more improved in (I) than (R); cognitive strategies, social support, philosophical beliefs, and active coping had no differences between groups. In functional domain: social roles, physical functions, mental performance significantly more improved in (I); social relations and physical performance no differences between groups.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	'assignment of random numbers'.
Allocation concealment?	High risk	Inadequate
Blinding?   All outcomes ‐ patients?	High risk
Blinding?   All outcomes ‐ providers?	High risk
Blinding?   All outcomes ‐ outcome assessors?	High risk
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	High risk
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	High risk
Free of selective reporting?	Low risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	Low risk
Compliance acceptable?	Low risk
Timing outcome assessments similar?	Low risk

Methods	RCT; 'computer‐generated random list'
Participants	64 patients, aged 25–60 years, with CLBP referred for spine surgery. All had pain lasting longer than 1 year, a score of at least 30 on the ODI, and evidence of disc degeneration at L4–L5 and/or L5–S1 on radiographic examination. Exclusion criteria were widespread pain, pelvic pain, spinal stenosis, recurrent herniation, generalised disc degeneration, previous surgery or fracture, and other serious disease. 3 patients were lost to follow‐up at 1 year and were not included in the analysis.
Interventions	Behavioural treatment (I): cognitive intervention consisting of a lecture; reinforced by three daily physical exercise sessions (˜25 hours/week) for 3 weeks (N = 26). Reference treatment (R): instrumented lumbar fusion with posterior transpedicular screws followed by post‐operative rehabilitation at the choice of the surgeon (N = 35).
Outcomes	Overall improvements in ODI at the 1‐year follow‐up visit did not differ significantly between (I) and (R). The mean difference (95%CI) in change between groups was 2.3 (‐6.8 to 11.4) in favour of (R). Fear avoidance beliefs and fingertip‐floor distance were significantly improved more after (I) than (R), and lower limb pain was significantly reduced more after (R) than (I). The success rate according to an independent observer was 70% after (R) and 76% after (I). The early complication rate in the (R) group was 18%.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	'computer‐generated random list'
Allocation concealment?	Low risk	Adequate
Blinding?   All outcomes ‐ patients?	High risk	not reported, unable to blind due to nature of intervention
Blinding?   All outcomes ‐ providers?	High risk	as above
Blinding?   All outcomes ‐ outcome assessors?	High risk	"physical therapist and a specialist in physical medicine and rehabilitation carried out blind follow‐up measurements"
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	Low risk	Figure 1
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	Low risk	"The results were analysed according to the method of intention‐to‐treat"
Free of selective reporting?	Low risk	all pre‐specified outcomes are reported
Similarity of baseline characteristics?	Low risk	Table 1, 2
Co‐interventions avoided or similar?	Unclear risk	Unclear from text
Compliance acceptable?	High risk	"Four patients randomised to lumbar fusion did not have surgery. Two patients randomised to cognitive intervention   and exercises did not attend treatment. Additionally, 1 patient dropped out after the first treatment period and   had surgery."
Timing outcome assessments similar?	Low risk	Figure 1

Methods	RCT; 'randomly assigned...matched for age and sex'.
Participants	72 patients with CLBP (minimum of 2 years history, twice weekly LBP) who responded to media announcements and were aged 20‐65 years. Patients were excluded if receiving compensation, had clinical depression, psychosis, or previous low‐back surgery. 6 patients withdrew before completion of the study and were not included in the analysis.
Interventions	Behavioural treatment (I): auditory EMG biofeedback training in sitting position until decrease and increase of 2 µv without feedback was reached, max. 8 sessions (N = 22). Reference treatment (R1): placebo feedback of back temperature (N = 22). Reference treatment (R2): waiting list control (N = 22).
Outcomes	No significant differences between groups on pain intensity, functional status, or psychosocial status at short‐term (post‐treatment) or intermediate‐term (3 months) follow‐up. No data presented.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	'randomly assigned...matched for age and sex'
Allocation concealment?	Unclear risk	Unclear
Blinding?   All outcomes ‐ patients?	Low risk
Blinding?   All outcomes ‐ providers?	High risk
Blinding?   All outcomes ‐ outcome assessors?	Low risk
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	Low risk
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	High risk
Free of selective reporting?	Low risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	Unclear risk	Unclear from text
Compliance acceptable?	Unclear risk	Unclear from text
Timing outcome assessments similar?	Low risk

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (short term)	5	239	Std. Mean Difference (IV, Random, 95% CI)	‐0.60 [‐0.97, ‐0.22]
2 Functional status (short term)	4	134	Std. Mean Difference (IV, Random, 95% CI)	‐0.37 [‐0.87, 0.13]
3 Depression (short term)	4	194	Mean Difference (IV, Random, 95% CI)	‐1.92 [‐6.16, 2.32]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (short term)	2	93	Std. Mean Difference (IV, Random, 95% CI)	0.41 [‐0.63, 1.45]
2 Pain (intermediate term)	2	82	Std. Mean Difference (IV, Random, 95% CI)	0.35 [‐0.64, 1.35]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (short‐term)	2	61	Std. Mean Difference (IV, Random, 95% CI)	‐0.24 [‐1.36, 0.87]
2 Pain (intermediate‐term)	2	44	Std. Mean Difference (IV, Random, 95% CI)	‐0.30 [‐2.59, 1.98]
3 Pain (long‐term)	2	48	Std. Mean Difference (IV, Random, 95% CI)	‐0.89 [‐3.64, 1.87]
4 Functional status (short‐term)	2	61	Mean Difference (IV, Random, 95% CI)	‐2.01 [‐10.02, 5.99]
5 Functional status (intermediate‐term)	2	47	Mean Difference (IV, Random, 95% CI)	‐3.20 [‐16.44, 10.04]
6 Functional status (long‐term)	2	51	Mean Difference (IV, Random, 95% CI)	‐2.23 [‐12.59, 8.13]
7 Depression (short‐term)	2	61	Mean Difference (IV, Random, 95% CI)	‐3.10 [‐11.43, 5.23]
8 Depression (intermediate‐term)	2	47	Mean Difference (IV, Random, 95% CI)	‐4.66 [‐10.94, 1.61]
9 Depression (long‐term)	2	51	Mean Difference (IV, Fixed, 95% CI)	‐0.64 [‐4.61, 3.32]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (short‐term)	3	161	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.15 [‐0.46, 0.16]
2 Pain (intermediate‐term)	3	139	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.23 [‐0.57, 0.11]
3 Pain (long‐term)	3	140	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.31 [‐0.65, 0.03]
4 Functional status (short‐term)	2	77	Std. Mean Difference (IV, Fixed, 95% CI)	0.21 [‐0.24, 0.67]
5 Functional status (intermediate‐term)	2	61	Std. Mean Difference (IV, Random, 95% CI)	‐0.23 [‐1.01, 0.55]
6 Functional status (long‐term)	2	66	Std. Mean Difference (IV, Random, 95% CI)	‐0.50 [‐1.56, 0.56]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (short term)	3	97	Std. Mean Difference (IV, Fixed, 95% CI)	0.09 [‐0.31, 0.50]
2 Pain (intermediate term)	2	62	Std. Mean Difference (IV, Random, 95% CI)	0.47 [‐0.42, 1.35]
3 Functional status (short term)	3	97	Std. Mean Difference (IV, Fixed, 95% CI)	0.38 [‐0.02, 0.78]
4 Functional status (intermediate term)	2	62	Std. Mean Difference (IV, Random, 95% CI)	0.13 [‐0.81, 1.07]
5 Depression (short term)	3	97	Mean Difference (IV, Fixed, 95% CI)	2.89 [0.55, 5.24]
6 Depression (intermediate term)	2	62	Mean Difference (IV, Fixed, 95% CI)	1.84 [‐0.43, 4.11]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (short term)	2	330	Mean Difference (IV, Fixed, 95% CI)	‐5.18 [‐9.79, ‐0.57]
2 Pain (intermediate term)	2	319	Mean Difference (IV, Fixed, 95% CI)	‐4.29 [‐9.28, 0.69]
3 Back specific functional status (short term)	2	330	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.41, 0.02]
4 Back specific functional status (intermediate term)	2	319	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.12 [‐0.34, 0.10]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (short term)	2	146	Mean Difference (IV, Fixed, 95% CI)	‐2.31 [‐6.33, 1.70]
2 Pain (intermediate term)	2	137	Mean Difference (IV, Fixed, 95% CI)	1.18 [‐3.16, 5.53]
3 Pain (long term)	2	136	Mean Difference (IV, Fixed, 95% CI)	0.14 [‐4.40, 4.67]
4 Depression (short term)	2	146	Std. Mean Difference (IV, Fixed, 95% CI)	0.25 [‐0.07, 0.58]
5 Depression (intermediate term)	2	137	Std. Mean Difference (IV, Fixed, 95% CI)	0.02 [‐0.32, 0.35]
6 Depression (long term)	2	136	Std. Mean Difference (IV, Fixed, 95% CI)	0.07 [‐0.27, 0.41]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain intensity (short term)	2	59	Mean Difference (IV, Random, 95% CI)	‐0.13 [‐1.01, 0.75]
2 Pain Intensity (intermediate term)	2	45	Mean Difference (IV, Fixed, 95% CI)	‐0.11 [‐0.67, 0.44]
3 Depression (short term)	2	59	Mean Difference (IV, Fixed, 95% CI)	1.56 [‐1.71, 4.83]
4 Depression (intermediate term)	2	50	Mean Difference (IV, Random, 95% CI)	0.17 [‐6.85, 7.19]
5 Functional status (short term)	2	59	Mean Difference (IV, Fixed, 95% CI)	‐6.26 [‐12.71, 0.19]
6 Functional status (intermediate term)	2	51	Mean Difference (IV, Fixed, 95% CI)	‐0.93 [‐6.71, 4.84]

Methods	RCT; 'randomly assigned'.
Participants	36 volunteers, recruited through advertisements, with CLBP in the area T8‐S1 for at least 1 year, aged 18‐55 years and experiencing daily pain. Subjects were excluded for a history of back surgery, positive straight leg raise test, loss of reflexes, lower limb weakness, scoliosis, or other serious disease.
Interventions	Behavioural treatment (I1): progressive relaxation training (Lehrer & Woolfolk), 10 35‐min. sessions (N = 12). Behavioural treatment (I2): single motor unit biofeedback training (Johnson, Mulder), 10 x 35‐min. sessions (N = 12). Reference treatment (R): education on anatomy, exercise, depression, and stress management, 10 x 35‐min. sessions (N = 12).
Outcomes	Mean scores on McGill Pain Questionnaire (MPQ) and pain intensity (VAS) pretreatment (I1) 31.08, 2.51, (I2) 28.75, 2.23, (R) 34.50, 3.48; posttreatment (I1) 27.67, 1.90, (I2) 16.08, 1.26, (R) 28.58, 2.47; and after 3 months (I1) 32.33, 1.78, (I2) 15.33, 0.72, (R) 20.08, 0.87. (I2) significantly more improved after 3 months than (I1). No significant differences on pain intensity between groups.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	'randomly assigned'
Allocation concealment?	Unclear risk	Unclear
Blinding?   All outcomes ‐ patients?	High risk
Blinding?   All outcomes ‐ providers?	High risk
Blinding?   All outcomes ‐ outcome assessors?	High risk
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	Unclear risk	Unclear from text
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	Unclear risk	Unclear from text
Free of selective reporting?	Low risk
Similarity of baseline characteristics?	High risk
Co‐interventions avoided or similar?	Unclear risk	Unclear from text
Compliance acceptable?	Low risk
Timing outcome assessments similar?	Low risk

Methods	RCT; 'randomisation was generated centrally by computer program'
Participants	349 participants who were considered candidates for spinal fusion, aged 18‐55 years, with CLBP of at least one year duration. Patients were excluded if they had an infection or other comorbidity which contraindicated treatment, psychiatric disease, or were pregnant.
Interventions	Behavioural treatment (I): intensive rehabilitation programme of education and exercise based on principles of cognitive‐behaviour therapy (identify and overcome fears and unhelpful beliefs), 5 days per week for 3 weeks (N = 173) Reference treatment (R): spinal stabilisation surgery at discretion of the surgeon (N = 176)
Outcomes	The mean (SD) ODI changed from 46.5 (14.6) to 34.0 (21.1) in the (R) group and from 44.8 (14.8) to 36.1 (20.6) in the (I) group after 24 months follow‐up. The estimated difference in change (from baseline to 24 months) between the groups was ‐4.1 (95%CI ‐8.1 to ‐0.1, P=0.045) in favour of (R). No significant differences between groups were observed in any of the other outcome measures. Intra‐operative complications occurred in 19 surgical cases.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	'randomisation was generated centrally by computer program'
Allocation concealment?	Unclear risk	Unclear
Blinding?   All outcomes ‐ patients?	High risk	not reported
Blinding?   All outcomes ‐ providers?	High risk	"We were not able to blind the trial research therapists to patient allocation after the baseline assessment."
Blinding?   All outcomes ‐ outcome assessors?	High risk	not reported
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	Unclear risk	Borderline acceptable drop‐out rate, reasons not described
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	Low risk	"We carried out an intention to treat analysis"
Free of selective reporting?	High risk	did not report DRAM at follow up
Similarity of baseline characteristics?	Low risk	Table 1
Co‐interventions avoided or similar?	High risk	not similar, Table 2
Compliance acceptable?	High risk	"Forty eight (28%) patients randomised to rehabilitation had surgery by two years. Seven (4%) patients randomised   to surgery had rehabilitation instead of surgery."
Timing outcome assessments similar?	Low risk	Figure, flow of participants

PERMALINK

Behavioural treatment for chronic low‐back pain

Nicholas Henschke

Raymond WJG Ostelo

Maurits W van Tulder

Johan WS Vlaeyen

Stephen Morley

Willem JJ Assendelft

Chris J Main

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Summary of findings for the main comparison. Summary of findings: Behavioural treatment versus waiting list control.

Summary of findings 2. Summary of findings: Comparisons among behavioural treatments.

Summary of findings 3. Summary of findings: Behavioural treatments versus other treatments.

Summary of findings 4. Summary of findings: Behavioural treatments + other treatments versus other treatments alone.

Background

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Search methods for identification of studies

Data collection and analysis

Study selection

Risk of bias assessment

Clinical relevance

Data extraction

Data analysis and the GRADE approach

Results

Description of studies

Risk of bias in included studies

1.

Clinical relevance

1. Results of clinical relevance assessment.

Effects of interventions

1. Behavioural treatment versus waiting list controls

Summary

1.1 Respondent therapy (progressive relaxation) versus waiting list controls

1.1. Analysis.

1.2. Analysis.

1.3. Analysis.

1.2 Respondent therapy (EMG biofeedback) versus waiting list controls

2.1. Analysis.

2.2. Analysis.

1.3 Operant therapy versus waiting list controls

3.1. Analysis.

3.2. Analysis.

3.3. Analysis.

1.4 Cognitive therapy versus waiting list controls

4.1. Analysis.

4.2. Analysis.

1.5 Combined behavioural therapy versus waiting list controls

5.1. Analysis.

5.2. Analysis.

5.3. Analysis.

2. Comparison among different types of behavioural treatment

Summary

2.1 Respondent therapy (EMG biofeedback) versus respondent therapy (progressive relaxation)

2.2 Cognitive versus operant therapy

6.1. Analysis.

6.2. Analysis.

2.3 Cognitive versus respondent therapy

2.4 Operant versus respondent therapy

2.5 Combined behavioural therapy versus cognitive therapy

7.1. Analysis.

7.2. Analysis.

7.3. Analysis.

7.4. Analysis.

7.5. Analysis.

7.6. Analysis.

Methods	RCT; 'randomised by means of computer generated code'
Participants	234 patients, 18 to 65 years of age, still reporting LBP 3 months after an initial GP consultation. Criteria for exclusion included having a consultation for LBP in past 6 months, presence of '"red flags", pregnancy or recent childbirth, major rheumatologic, neurologic, neoplastic, or other conditions, previous spinal surgery, major psychiatric illness, or a history of drug or alcohol abuse.
Interventions	Behavioural treatment (I): community‐based treatment program using a cognitive behavioral approach (problem solving, pacing and regulation of activity, challenging distorted cognitions, identifying helpful and unhelpful thoughts), eight 2‐hour group sessions over a 6‐week period + educational pack (booklet + audio cassette) (N = 116) Reference treatment (R): educational pack (booklet + audio cassette) (N = 118)
Outcomes	The (I) group showed only a small and non‐significant effect at reducing pain (‐3.6 mm; 95%CI ‐8.5 to 1.2mm) and improving back pain specific function using the RMDQ (‐0.6 points; 95%CI, ‐1.6 to 0.4). The mean incremental cost‐effectiveness ratio was £5000 (U.S. $8650) per QALY.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	'randomised by means of computer generated code'
Allocation concealment?	Low risk	Adequate
Blinding?   All outcomes ‐ patients?	High risk	"Given the nature of the interventions, it was not possible to blind subjects or staff to treatment allocation"
Blinding?   All outcomes ‐ providers?	High risk	as above
Blinding?   All outcomes ‐ outcome assessors?	High risk	as above
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	Unclear risk	Acceptable drop‐out rate, no reasons given
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	Low risk	"All analyses were conducted according to “intention to treat” (ITT) principles"
Free of selective reporting?	Low risk	all outcome measures reported
Similarity of baseline characteristics?	Low risk	Table 1
Co‐interventions avoided or similar?	Unclear risk	Unclear from text
Compliance acceptable?	High risk	compliance unacceptable, 63% attended at least half of the sessions
Timing outcome assessments similar?	Low risk	Figure 1

Methods	RCT; 'before first pretreatment measurement each patient was given a number written down on a card and folded up. An independent researcher blindly drew a card and assigned it to one of the three treatments.'
Participants	148 patients with CLBP for at least 6 months, aged 18‐65 years, observable pain behaviour, partner willing to participate, referred by general practitioner or specialist. Criteria to exclude patients included: illiteracy, pregnancy, involvement in litigation, alcohol or drug abuse, serious psychopathology, and specific medical pathology.
Interventions	Behavioural treatment (I1): operant treatment (graded aerobic exercises, partner involvement) and cognitive treatment plus relaxation (decreasing distorted pain cognitions, increasing self‐expectations, imagery, applied relaxation) (N = 59). Behavioural treatment (I2): operant treatment plus group discussion, groups of 5 patients (N = 58). Reference treatment (R): waiting list control group (N = 31).
Outcomes	Post‐treatment (I1) and (I2) had significantly less negative affect, higher activity tolerance, less pain behaviour, higher pain coping and higher pain control than (R). Post‐treatment (I1) had better pain coping and pain control than (I2). No significant differences at follow‐up on any outcome measure including costs and quality of life. Data in graphs.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	'before first pretreatment measurement each patient was given a number written down on a card and folded up. An independent researcher blindly drew a card and assigned it to one of the three treatments.'
Allocation concealment?	Low risk	Adequate
Blinding?   All outcomes ‐ patients?	Low risk
Blinding?   All outcomes ‐ providers?	High risk
Blinding?   All outcomes ‐ outcome assessors?	Low risk
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	Low risk
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	Low risk
Free of selective reporting?	Low risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	Low risk
Compliance acceptable?	High risk
Timing outcome assessments similar?	Low risk

Methods	RCT; 'predetermined and computer‐generated randomisation schedule'
Participants	85 patients, 18‐65 years of age, with CLBP reporting some disability (RMDQ > 3) and moderate pain‐related fear (Tampa Scale for Kinesiophobia > 33), referred by physicians or responding to newspaper advertisements. Exclusion criteria were illiteracy, pregnancy, substance abuse, involvement in litigation, specific medical disorders preventing participation in physical exercise, and serious psychopathology.
Interventions	Behavioural treatment (I1): exposure in vivo (cognitive therapy, education, engaging in fear‐provoking activities) for approximately 16 sessions (N = 42). Behavioural treatment (I2): operant graded activity (positive reinforcement of healthy behaviours, education, activity quotas) for approximately 26 sessions (N = 43).
Outcomes	No significant difference was found between (I1) and (I2) in functional disability (QBPDS) and patient specific complaints post‐treatment and after an intermediate‐term (6 months) follow‐up. (I1) had significantly lower PHODA‐SeV and PCS scores immediately and 6 months post‐treatment. No difference between groups was found for daily activity level or pain intensity (MPQ) immediately post‐treatment or after 6 months follow‐up.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	'computer‐generated randomisation schedule'
Allocation concealment?	Low risk	Adequate
Blinding?   All outcomes ‐ patients?	Unclear risk	treatment names not revealed to participants, credibility of treatments not evaluated
Blinding?   All outcomes ‐ providers?	High risk	"all teams provided both treatment arms"
Blinding?   All outcomes ‐ outcome assessors?	Unclear risk	self‐report primary outcome measures, patient blinding unclear
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	Low risk	reported in Figure 1. Flow of participants
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	Low risk	"Intention‐to‐treat analyses were employed, including all patients that were originally enrolled in the study, irrespective of their completing therapy or assessments"
Free of selective reporting?	Unclear risk	various questionnaires were administered and not reported (considered irrelevant within the scope of the study)
Similarity of baseline characteristics?	Low risk	Table 1 and 2
Co‐interventions avoided or similar?	Unclear risk	advised to avoid co‐interventions, not checked
Compliance acceptable?	High risk	"treatment was prematurely terminated either by patient or the therapist in 12 patients (29%) of the EXP and 14 patients (33%) of the GA"
Timing outcome assessments similar?	Low risk	"Assessments occurred ... directly after termination of treatment (Post‐treatment), and 6 months (Follow‐up 1), and 12 months (Follow‐up 2) afterwards."

Methods	RCT; 'randomly assigned using a table of random numbers'.
Participants	66 female nurses, aged 20‐59 years, current episode of LBP, sick listed some time during previous 2 years, currently working.
Interventions	Behavioural treatment (I): 5 week‐period in a back clinic; 8 hours / day mostly in groups of 6 patients; exercise activities (walking, swimming, jogging, cycling) 4 hours / day; ergonomic education, individual physical therapy programs, behaviour therapy techniques (N = 36). Reference treatment (R): waiting‐list control: no additional active treatment (N = 30).
Outcomes	Pain intensity (VAS) significantly better in (I) than (R) after 6‐weeks and 6‐months (data in graphs). Psychological outcome measures (fatigue, anxiety, sleep quality, observed pain behaviour, mood, helplessness) similar results.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	'randomly assigned using a table of random numbers'
Allocation concealment?	Low risk	Adequate
Blinding?   All outcomes ‐ patients?	High risk
Blinding?   All outcomes ‐ providers?	High risk
Blinding?   All outcomes ‐ outcome assessors?	Low risk
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	Low risk
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	Low risk
Free of selective reporting?	Low risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	High risk
Compliance acceptable?	Low risk
Timing outcome assessments similar?	Low risk

Methods	RCT; crossover design; 'randomised according to a computer generated list'
Participants	46 patients, 18–60 years old, with chronic LBP who were deemed fearful (TSK score > 35) and had no red flags, recruited through referrals via local primary care facilities, advertisements in local newspapers, and National Insurance Authority offices.
Interventions	Behavioural treatment (I): Exposure in vivo (13 sessions of psycho‐education, goal setting, graded exposure to fearful activities) and treatment as usual (N = 21). Reference treatment (R): Waiting list (median 14 weeks) and treatment as usual (N = 25).
Outcomes	Post‐treatment, a significant interaction was found for disability as measured by the ADL Scale where (I) improved more than (R). Mean (SD) scores post‐treatment were: (I) 31.0 (11.8); (R) 29.6 (11.4). There was no significant difference between the groups on pain intensity or pain related fear. There were 12 dropouts (8 in (I) and 4 in (R)) during the first treatment phase and an additional 4 when (R) crossed over to (I).
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	'randomised according to a computer generated list'
Allocation concealment?	Unclear risk	Unclear
Blinding?   All outcomes ‐ patients?	High risk	not reported
Blinding?   All outcomes ‐ providers?	High risk	not reported
Blinding?   All outcomes ‐ outcome assessors?	High risk	not reported
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	High risk	not acceptable, high drop out rate ˜30%
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	High risk	drop out rate too high
Free of selective reporting?	Low risk	all specified outcomes reported
Similarity of baseline characteristics?	Unclear risk	prognostic indicators different, no outcome scores
Co‐interventions avoided or similar?	Unclear risk	both groups had treatment as usual, uncontrolled
Compliance acceptable?	High risk	Figure 2
Timing outcome assessments similar?	Low risk	Figure 2

Methods	RCT; 'randomly assigned on the basis of alternate allocation'. Waiting list controls not randomised.
Participants	44 patients with chronic LBP, aged 18‐65 years, referred by medical practitioners or self‐referred through media publicity. Patients were excluded if they had other chronic pain conditions, alcohol abuse, or a history of psychosis.
Interventions	Behavioural treatment (I1): cognitive behavior therapy (education, goal setting, autogenic relaxation, cognitive pain control and restructuring techniques, homework tasks); groups of 4 subjects, 8 sessions of 1 hr, twice weekly (N = 16). Behavioural treatment (I2): electromyographic biofeedback (multiple, short criterion oriented feedback trials, sitting position, plus psycho‐educational session, diaphragmatic breathing exercises), 1 hr, twice weekly, 8 sessions (N = 16). Reference treatment (R): waiting list controls (N = 12).
Outcomes	Mean (SD) pretreatment, posttreatment and after 6 months for pain: (I1) 15.72 (13.97), 10.38 (11.37), 8.68 (10.54), (I2) 16.81 (11.66), 8.42 (6.05), 8.40 (7.31), (R) 16.37 (11.47), 17.56 (9.05), for disability: (I1) 27.25 (19.71), 18.00 (15.19), 16.38 (14.02), (I2) 22.56 (9.93), 15.12 (8.38), 23.06 (23.28), (R) 25.17 (13.80), 26.33 (17.09). No significant differences between (I1) and (I2) for pain, functional status and behavioral outcomes (depression, anxiety, coping, pain beliefs) posttreatment and after 6 months.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	High risk	'randomly assigned on the basis of alternate allocation'. Waiting list controls not randomised.
Allocation concealment?	High risk	Inadequate
Blinding?   All outcomes ‐ patients?	High risk
Blinding?   All outcomes ‐ providers?	High risk
Blinding?   All outcomes ‐ outcome assessors?	High risk
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	Low risk
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	High risk
Free of selective reporting?	Low risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	Low risk
Compliance acceptable?	Low risk
Timing outcome assessments similar?	Low risk

Methods	RCT; 'randomly divided', 'alternation method'.
Participants	20 patients with chronic LBP, aged 20‐55 years, volunteers recruited through newspaper article.
Interventions	Behavioural treatment (I): auditory and visual EMG biofeedback training in standing position, 15 sessions in 3 weeks (N = 10). Reference treatment (R): waiting list control, no treatment (N = 10).
Outcomes	Mean (SD) pain level (duration x intensity) pre‐ and post‐treatment (I) 15.8 (9.4), 14.3 (8.6) vs (R) 18.4 (11.8), 19.1 (15.6). Not significant.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	High risk	'randomly divided', 'alternation method'
Allocation concealment?	High risk	Inadequate
Blinding?   All outcomes ‐ patients?	High risk
Blinding?   All outcomes ‐ providers?	High risk
Blinding?   All outcomes ‐ outcome assessors?	High risk
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	Low risk
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	Low risk
Free of selective reporting?	Low risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	Low risk
Compliance acceptable?	Low risk
Timing outcome assessments similar?	Low risk

Methods	pragmatic RCT; randomised using a 'minimisation technique'
Participants	234 patients with chronic LBP, 18 to 65 years of age, referred from general practitioners. Patients were excluded for the following   reasons: pregnancy; co‐existing major medical illness; psychiatric disorder; in litigation; previous use of reflexology and contraindication to reflexology including: recent surgery and circulatory disorders of the lower limb.
Interventions	Behavioural treatment (I): Progressive muscle relaxation for six 1 hour sessions at weekly intervals for six weeks in groups of 1–4 (N = 69). Reference treatment (R): Reflexology for six treatments of approximately 1 hour duration, over a period of 6–8 weeks (N = 68). Reference treatment (R2): Usual care (N = 54).
Outcomes	There were no significant differences between groups on the primary outcome variables of pain (SF‐36) and functioning (ODI) or any of the secondary outcomes over the period of the trial. Mean (SD) scores at baseline, post‐treatment, and six month follow‐up on the primary outcome measure of pain intensity (SF‐36) were: (I) 40.7 (28.6), 37.9 (27.0), 41.3 (28.5); (R) 44.5 (24.8), 35.0 (25.9), 41.3 (28.5); (R2) 40.6 (26.7), 48.9 (29.3), 42.7 (28.4).
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Method of randomisation unclear
Allocation concealment?	Unclear risk	Unclear
Blinding?   All outcomes ‐ patients?	High risk	not reported, pragmatic trial
Blinding?   All outcomes ‐ providers?	High risk	as above
Blinding?   All outcomes ‐ outcome assessors?	High risk	as above
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	High risk	Figure 1, no reasons for drop‐out described
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	High risk	number of patients in analysis was not reported
Free of selective reporting?	Low risk	all specified outcomes are reported
Similarity of baseline characteristics?	Low risk	Table 1, 3
Co‐interventions avoided or similar?	High risk	Table 2 describes usual care throughout trial
Compliance acceptable?	High risk	Figure 1
Timing outcome assessments similar?	Low risk	Figure 1, Table 3

Methods	Two part RCT: part A (individual vs. group therapy), part B (short duration vs. long duration); 'allocated randomly'.
Participants	Part A : 120 patients with CLBP, aged 18‐65 years, referred from orthopaedic departments and primary care physicians. Part B : 161 patients with chronic LBP, aged 18‐65 years, referred from primary care physicians. Patients who were awaiting surgery or were receiving treatment elsewhere were excluded.
Interventions	All groups received a multimodal behavioural treatment program: education, cognitive therapy, graded aerobic exercise, and relaxation therapy. In addition, the 30‐ and 60‐ hour groups of Part B swam daily. Part A: (I1) group treatment, 8‐10 patients (N = 26) vs. (I2) individual treatment (N = 24). Part B (group treatment): (I3) 15‐hour program (N = 22) vs. (I4) 30‐hour program (N = 22) vs. (I5) 60‐hour program (N = 16).
Outcomes	Part A: No significant differences between groups on pain, functional status, and psychological domain (somatic perception, depression, locus of control, self‐efficacy) post‐treatment or after 6 months. Data in graphs.   Part B: No significant differences between groups on pain, functional status, and psychological domain (somatic perception, depression, locus of control, self‐efficacy) post‐treatment or after 6 months. Data in graphs.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	High risk	'allocated randomly'
Allocation concealment?	High risk	Inadequate
Blinding?   All outcomes ‐ patients?	High risk
Blinding?   All outcomes ‐ providers?	High risk
Blinding?   All outcomes ‐ outcome assessors?	High risk
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	High risk
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	High risk
Free of selective reporting?	Low risk
Similarity of baseline characteristics?	Low risk
Co‐interventions avoided or similar?	High risk
Compliance acceptable?	High risk
Timing outcome assessments similar?	Low risk

Methods	RCT; 'randomisation performed... using Rancode Professional 3.6'
Participants	409 patients with non‐specific LBP for at least 6 months, pre‐screened by pension insurance administration. Exclusion criteria were severe co‐morbidities, an indication of severe spinal pathology such as rheumatoid arthritis, osteoporosis, fibromyalgia, oncologic diseases, or radiologically proven intervertebral disc rupture. Further, patients were excluded if they had filed an application for early retirement or if they were unemployed for more than 12 months.
Interventions	Behavioural treatment (I): cognitive‐behavioural pain management program (relaxation, distraction of attention, cognitive reappraisal of pain and stress, coping strategies) in 6 group sessions, in addition to standard inpatient rehabilitation (N = 200). Reference treatment (R): standard inpatient rehabilitation (conventional 3‐week inpatient rehabilitation program consisting of physiotherapy in small groups, massage, electrotherapeutic measures, education, twice‐daily exercise program) (N = 209).
Outcomes	Post‐treatment, none of the behavioral, pain, or disability outcome measures displayed significant differences between (I) and (R). After 6 months, there were no significant differences between groups in quality‐adjusted life‐years gained or in direct medical or non‐medical costs.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	'randomisation performed... using Rancode Professional 3.6'
Allocation concealment?	Low risk	Adequate
Blinding?   All outcomes ‐ patients?	High risk	"Blinding of patients, clinic physicians, and the psychologists administering the treatment was not possible due to the nature of the intervention."
Blinding?   All outcomes ‐ providers?	High risk	as above
Blinding?   All outcomes ‐ outcome assessors?	High risk	as above
Incomplete outcome data addressed?   All outcomes ‐ drop‐outs?	High risk	Figure 1
Incomplete outcome data addressed?   All outcomes ‐ ITT analysis?	High risk	Table 2, only analysed patients who completed treatment
Free of selective reporting?	Low risk	all specified outcomes are reported
Similarity of baseline characteristics?	Low risk	Table 1
Co‐interventions avoided or similar?	Unclear risk	Unclear from text
Compliance acceptable?	Unclear risk	Unclear from text
Timing outcome assessments similar?	Low risk	Figure 1