Zara Hansen

Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis.

BACKGROUND Low-back pain is a common and costly problem. We estimated the effectiveness of a group cognitive behavioural intervention in addition to best practice advice in people with low-back pain in primary care. METHODS In this pragmatic, multicentre, randomised controlled trial with parallel cost-effectiveness analysis undertaken in England, 701 adults with troublesome subacute or chronic low-back pain were recruited from 56 general practices and received an active management advisory consultation. Participants were randomly assigned by computer-generated block randomisation to receive an additional assessment and up to six sessions of a group cognitive behavioural intervention (n=468) or no further intervention (control; n=233). Primary outcomes were the change from baseline in Roland Morris disability questionnaire and modified Von Korff scores at 12 months. Assessment of outcomes was blinded and followed the intention-to-treat principle, including all randomised participants who provided follow-up data. This study is registered, number ISRCTN54717854. FINDINGS 399 (85%) participants in the cognitive behavioural intervention group and 199 (85%) participants in the control group were included in the primary analysis at 12 months. The most frequent reason for participant withdrawal was unwillingness to complete questionnaires. At 12 months, mean change from baseline in the Roland Morris questionnaire score was 1.1 points (95% CI 0.39-1.72) in the control group and 2.4 points (1.89-2.84) in the cognitive behavioural intervention group (difference between groups 1.3 points, 0.56-2.06; p=0.0008). The modified Von Korff disability score changed by 5.4% (1.99-8.90) and 13.8% (11.39-16.28), respectively (difference between groups 8.4%, 4.47-12.32; p<0.0001). The modified Von Korff pain score changed by 6.4% (3.14-9.66) and 13.4% (10.77-15.96), respectively (difference between groups 7.0%, 3.12-10.81; p<0.0001). The additional quality-adjusted life-year (QALY) gained from cognitive behavioural intervention was 0.099; the incremental cost per QALY was 1786 pound sterling, and the probability of cost-effectiveness was greater than 90% at a threshold of 3000 pound sterling per QALY. There were no serious adverse events attributable to either treatment. INTERPRETATION Over 1 year, the cognitive behavioural intervention had a sustained effect on troublesome subacute and chronic low-back pain at a low cost to the health-care provider. FUNDING National Institute for Health Research Health Technology Assessment Programme.

A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain : the back skills training (BeST) trial

OBJECTIVES To estimate the clinical effectiveness of active management (AM) in general practice versus AM plus a group-based, professionally led cognitive behavioural approach (CBA) for subacute and chronic low back pain (LBP) and to measure the cost of each strategy over a period of 12 months and estimate cost-effectiveness. DESIGN Pragmatic multicentred randomised controlled trial with investigator-blinded assessment of outcomes. SETTING Fifty-six general practices from seven English regions. PARTICIPANTS People with subacute and chronic LBP who were experiencing symptoms that were at least moderately troublesome. INTERVENTIONS Participants were randomised (in a ratio of 2:1) to receive either AM+CBA or AM alone. MAIN OUTCOME MEASURES Primary outcomes were the Roland Morris Disability Questionnaire (RMQ) and the Modified Von Korff Scale (MVK), which measure LBP and disability. Secondary outcomes included mental and physical health-related quality of life (Short Form 12-item health survey), health status, fear avoidance beliefs and pain self-efficacy. Cost-utility of CBA was considered from both the UK NHS perspective and a broader health-care perspective, including both NHS costs and costs of privately purchased goods and services related to LBP. Quality-adjusted life-years (QALYs) were calculated from the five-item EuroQoL. RESULTS Between April 2005 and April 2007, 701 participants were randomised: 233 to AM and 468 to AM+CBA. Of these, 420 were female. The mean age of participants was 54 years and mean baseline RMQ was 8.7. Outcome data were obtained for 85% of participants at 12 months. Benefits were seen across a range of outcome measures in favour of CBA with no evidence of group or therapist effects. CBA resulted in at least twice as much improvement as AM. Mean additional improvement in the CBA arm was 1.1 [95% confidence interval (CI) 0.4 to 1.7], 1.4 (95% CI 0.7 to 2.1) and 1.3 (95% CI 0.6 to 2.1) change points in the RMQ at 3, 6 and 12 months respectively. Additional improvement in MVK pain was 6.8 (95% CI 3.5 to 10.2), 8.0 (95% CI 4.3 to 11.7) and 7.0 (95% CI 3.2 to 10.7) points, and in MVK disability was 4.3 (95% CI 0.4 to 8.2), 8.1 (95% CI 4.1 to 12.0) and 8.4 (95% CI 4.4 to 12.4) points at 3, 6 and 12 months respectively. At 12 months, 60% of the AM+CBA arm and 31% of the AM arm reported some or complete recovery. Mean cost of attending a CBA course was 187 pounds per participant with an additional benefit in QALYs of 0.099 and an additional cost of 178.06 pounds. Incremental cost-effectiveness ratio was 1786.00 pounds. Probability of CBA being cost-effective reached 90% at about 3000 pounds and remained at that level or above; at a cost-effectiveness threshold of 20,000 pounds the CBA group had an almost 100% probability of being considered cost-effective. User perspectives on the acceptability of group treatments were sought through semi-structured interviews. Most were familiar with key messages of AM; most who had attended any group sessions had retained key messages from the sessions and two-thirds talked about a reduction in fear avoidance and changes in their behaviour. Group sessions appeared to provide reassurance, lessen isolation and enable participants to learn strategies from each other. CONCLUSIONS Long-term effectiveness and cost-effectiveness of CBA in treating subacute and chronic LBP was shown, making this intervention attractive to patients, clinicians and purchasers. Short-term (3-month) clinical effects were similar to those found in high-quality studies of other therapies and benefits were maintained and increased over the long term (12 months). Cost per QALY was about half that of competing interventions for LBP and because the intervention can be delivered by existing NHS staff following brief training, the back skills training programme could be implemented within the NHS with relative ease. TRIAL REGISTRATION Current Controlled Trials ISRCTN37807450. FUNDING The National Institute for Health Research Health Technology Assessment programme.

A cognitive-behavioural programme for the management of low back pain in primary care: a description and justification of the intervention used in the Back Skills Training Trial (BeST; ISRCTN 54717854).

A multicentre randomised controlled trial has been commissioned to evaluate cognitive-behavioural (CB) approaches in the management of subacute and chronic low back pain in primary care. This paper describes the development of the CB intervention based on best-available evidence. Several methods were used to design the intervention. Risk factors for the development of chronic low back pain were identified from the literature to provide targets for treatment, essential components of a CB intervention were considered using the CB treatment model, and the optimal delivery method was used to balance clinical effectiveness and cost-effectiveness within primary care.

The Effectiveness of Cognitive Behavioural Treatment for Non-Specific Low Back Pain: A Systematic Review and Meta-Analysis.

Objectives To assess whether cognitive behavioural (CB) approaches improve disability, pain, quality of life and/or work disability for patients with low back pain (LBP) of any duration and of any age. Methods Nine databases were searched for randomised controlled trials (RCTs) from inception to November 2014. Two independent reviewers rated trial quality and extracted trial data. Standardised mean differences (SMD) and 95% confidence intervals were calculated for individual trials. Pooled effect sizes were calculated using a random-effects model for two contrasts: CB versus no treatment (including wait-list and usual care (WL/UC)), and CB versus other guideline-based active treatment (GAT). Results The review included 23 studies with a total of 3359 participants. Of these, the majority studied patients with persistent LBP (>6 weeks; n=20). At long term follow-up, the pooled SMD for the WL/UC comparison was -0.19 (-0.38, 0.01) for disability, and -0.23 (-0.43, -0.04) for pain, in favour of CB. For the GAT comparison, at long term the pooled SMD was -0.83 (-1.46, -0.19) for disability and -0.48 (-0.93, -0.04) for pain, in favour of CB. While trials varied considerably in methodological quality, and in intervention factors such as provider, mode of delivery, dose, duration, and pragmatism, there were several examples of lower intensity, low cost interventions that were effective. Conclusion CB interventions yield long-term improvements in pain, disability and quality of life in comparison to no treatment and other guideline-based active treatments for patients with LBP of any duration and of any age. Systematic Review Registration PROSPERO protocol registration number: CRD42014010536.

Group cognitive behavioural interventions for low back pain in primary care: extended follow-up of the Back Skills Training Trial (ISRCTN54717854).

Summary Long‐term follow‐up of a randomised controlled trial of a cognitive behavioural intervention for low back pain indicates that effects on disability and pain are maintained to at least 34 months. Abstract Group cognitive behavioural intervention (CBI) is effective in reducing low back pain and disability over a 12‐month period, in comparison to best practice advice in primary care. The aim was to study the effects of this CBI beyond 12 months. We undertook an extended follow‐up of our original randomised, controlled trial of a group CBI and best practice advice in primary care, in comparison to best practice advice alone. Participants were mailed a questionnaire including measures of disability, pain, health services resource use, and health‐related quality of life. The time of extended follow‐up ranged between 20 and 50 months (mean 34 months). Fifty‐six percent (395 of 701) of the original cohort provided extended follow‐up. Those who responded were older and had less disability and pain at baseline than did the original trial cohort. After 12 months, the improvements in pain and disability observed with CBI were sustained. For disability measures, the treatment difference in favour of CBI persisted (mean difference 1.3 Roland and Morris Disability Questionnaire points, 95% confidence interval 0.27 to 2.26; 5.5 Modified von Korff Scale disability points, 95% confidence interval 0.27 to 10.64). There was no between‐group difference in Modified von Korff Scale pain outcomes. The results suggest that the effects of a group CBI are maintained up to an average of 34 months. Although pain improves in response to best practice advice, longer‐term recovery of disability remains substantially less.

Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care: Back Skills Training Trial.

BackgroundLow back pain (LBP) is a major public health problem. Risk factors for the development and persistence of LBP include physical and psychological factors. However, most research activity has focused on physical solutions including manipulation, exercise training and activity promotion.Methods/DesignThis randomised controlled trial will establish the clinical and cost-effectiveness of a group programme, based on cognitive behavioural principles, for the management of sub-acute and chronic LBP in primary care. Our primary outcomes are disease specific measures of pain and function. Secondary outcomes include back beliefs, generic health related quality of life and resource use. All outcomes are measured over 12 months. Participants randomised to the intervention arm are invited to attend up to six weekly sessions each of 90 minutes; each group has 6–8 participants. A parallel qualitative study will aid the evaluation of the intervention.DiscussionIn this paper we describe the rationale and design of a randomised evaluation of a group based cognitive behavioural intervention for low back pain.

Treatment compliance and effectiveness of a cognitive behavioural intervention for low back pain: a complier average causal effect approach to the BeST data set

BackgroundGroup cognitive behavioural intervention (CBI) is effective in reducing low-back pain and disability in comparison to advice in primary care. The aim of this analysis was to investigate the impact of compliance on estimates of treatment effect and to identify factors associated with compliance.MethodsIn this multicentre trial, 701 adults with troublesome sub-acute or chronic low-back pain were recruited from 56 general practices. Participants were randomised to advice (control n = 233) or advice plus CBI (n = 468). Compliance was specified a priori as attending a minimum of three group sessions and the individual assessment. We estimated the complier average causal effect (CACE) of treatment.ResultsComparison of the CACE estimate of the mean treatment difference to the intention-to-treat (ITT) estimate at 12 months showed a greater benefit of CBI amongst participants compliant with treatment on the Roland Morris Questionnaire (CACE: 1.6 points, 95% CI 0.51 to 2.74; ITT: 1.3 points, 95% CI 0.55 to 2.07), the Modified Von Korff disability score (CACE: 12.1 points, 95% CI 6.07 to 18.17; ITT: 8.6 points, 95% CI 4.58 to 12.64) and the Modified von Korff pain score (CACE: 10.4 points, 95% CI 4.64 to 16.10; ITT: 7.0 points, 95% CI 3.26 to 10.74). People who were non-compliant were younger and had higher pain scores at randomisation.ConclusionsTreatment compliance is important in the effectiveness of group CBI. Younger people and those with more pain are at greater risk of non-compliance.Trial registrationCurrent Controlled Trials ISRCTN54717854

Physiotherapist-delivered cognitive-behavioural interventions are effective for low back pain, but can they be replicated in clinical practice? A systematic review

Abstract Purpose: To determine if physiotherapist-led cognitive-behavioural (CB) interventions are effective for low back pain (LBP) and described sufficiently for replication. Method: Randomised controlled trials (RCTs) of patients with LBP treated by physiotherapists using a CB intervention were included. Outcomes of disability, pain, and quality of life were assessed using the GRADE approach. Intervention reporting was assessed using the Template for Intervention Description and Replication. Results: Of 1898 titles, 5 RCTs (n = 1390) were identified. Compared to education and/or exercise interventions, we found high-quality evidence that CB had a greater effect (SMD; 95% CI) on reducing disability (−0.19; −0.32, −0.07), pain (−0.21; −0.33, −0.09); and moderate-quality evidence of little difference in quality of life (−0.06; −0.18 to 0.07). Sufficient information was provided on dose, setting, and provider; but not content and procedural information. Studies tended to report the type of CB component used (e.g., challenging unhelpful thoughts) with little detail on how it was operationalised. Moreover, access to treatment manuals, patient materials and provider training was lacking. Conclusions: With additional training, physiotherapists can deliver effective CB interventions. However, without training or resources, successful translation and implementation remains unlikely. Researchers should improve reporting of procedural information, provide relevant materials, and offer accessible provider training. Implications for Rehabilitation Previous reviews have established that traditional biomedical-based treatments (e.g., acupuncture, manual therapy, massage, and specific exercise programmes) that focus only on physical symptoms do provide short-term benefits but the sustained effect is questionable. A cognitive-behavioural (CB) approach includes techniques to target both physical and psychosocial symptoms related to pain and provides patients with long-lasting skills to manage these symptoms on their own. This combined method has been used in a variety of settings delivered by different health care professionals and has been shown to produce long-term effects on patient outcomes. What has been unclear is if these programmes are effective when delivered by physiotherapists in routine physiotherapy settings. Our study synthesises the evidence for this context. We have confirmed with high-quality evidence that with additional training, physiotherapists can deliver CB interventions that are effective for patients with back pain. Physiotherapists who are considering enhancing their treatment for patients with low back pain should consider undertaking some additional training in how to incorporate CB techniques into their practice to optimise treatment benefits and help patients receive long-lasting treatment effects. Importantly, our results indicate that using a CB approach, including a variety of CB techniques that could be easily adopted in a physical therapy setting, provides greater benefits for patient outcomes compared to brief education, exercise or physical techniques (such as manual therapy) alone. This provides further support that a combined treatment approach is likely better than one based on physical techniques alone. Notably, we identified a significant barrier to adopting any of these CB interventions in practice. This is because no study provided a description of the intervention or accessible training materials that would allow for accurate replication. Without access to provider training and/or resources, we cannot expect this evidence to be implemented in practice with optimal effects. Thus, we would urge physiotherapists to directly contact authors of the studies for more information on how to incorporate their interventions into their settings.

Development and delivery of a physiotherapy intervention for the early management of whiplash injuries: the Managing Injuries of Neck Trial (MINT) Intervention.

This paper describes the development and implementation of a physiotherapy intervention for a large multicentred randomised controlled trial of the early management of whiplash injuries in a National Health Service setting. Participants were eligible if they were classified as having whiplash-associated disorder grades I to III and self-referred for treatment within 6 weeks of injury. The intervention development was informed through a variety of methods including the current evidence base, published guidelines, clinician opinion, a pilot study and expert opinion. The intervention was targeted at known, potentially modifiable risk factors for poor recovery, and utilised manual therapy, exercises and psychological strategies. The treatment was individually tailored, with a maximum of six treatments allowed within the trial protocol over an 8-week period. The intervention was delivered to 300 participants. The amount and types of treatments delivered are described.

Explaining How Cognitive Behavioral Approaches Work for Low Back Pain: Mediation Analysis of the Back Skills Training Trial.

STUDY DESIGN .: This is secondary research examining the longitudinal mediation effect within a structural equation model. OBJECTIVE .: To identify possible mechanisms which mediate the effects of a cognitive behavioural approach upon disability and pain in low back pain patients. SUMMARY OF BACKGROUND DATA .: Cognitive behavioural interventions (CBIs) can improve pain and disability in low back pain (LBP) but the mechanisms of action are unclear. We used data from a large randomised controlled trial to investigate mediators of the treatment effect of CBI. METHODS .: Pain self-efficacy, fear-avoidance, physical and mental functioning were selected as candidate mediators based on the theoretical rationale of the intervention. The primary treatment outcomes were the Roland Morris Questionnaire (RMDQ) and the modified-Von Korff scale (MVK pain and disability) at 12-months. We used structural equation models to estimate the contribution of mediators. All models were tested for goodness-of-fit using chi-square, Root Mean Square Error of Approximation, Adjusted Goodness of Fit Index and Bentler Comparative Fit Index. RESULTS .: We included 701 adults with LBP. The average RMDQ score at baseline for those on the intervention arm was 8.8 (Standard Deviation 5.0). The intervention was effective in reducing disability and pain at 12-months. Change in mental functioning was not a significant mediator. Changes to pain self-efficacy, fear-avoidance and physical functioning were causal mediators of the treatment effect at 12-months (RMDQ b= -0.149, p < 0.001; MVK-pain b = -0.181, p < 0.001 and MVK-disability b = -0.180, p < 0.001). Overall, the SEM model exceeded the threshold for acceptable goodness-of-fit. CONCLUSIONS .: Fear-avoidance and self-efficacy were important causal mediators of the cognitive behavioural treatment effect. Self-assessed change in physical function was a causal mediator but mental functioning was not. This suggests people need to experience meaningful change in physical function and beliefs but not in mental functioning associated with LBP, to achieve a treatment benefit. LEVEL OF EVIDENCE 2.STUDY DESIGN This is secondary research examining the longitudinal mediation effect within a structural equation model. OBJECTIVE To identify possible mechanisms that mediate the effects of a cognitive behavioral approach upon disability and pain in low back pain patients. SUMMARY OF BACKGROUND DATA Cognitive behavioral interventions (CBIs) can improve pain and disability in low back pain (LBP) but the mechanisms of action are unclear. We used data from a large randomized controlled trial to investigate mediators of the treatment effect of CBI. METHODS Pain self-efficacy, fear avoidance, and physical and mental functioning were selected as candidate mediators based on the theoretical rationale of the intervention. The primary treatment outcomes were the Roland Morris Questionnaire (RMDQ) and the modified Von Korff scale (MVK pain and disability) at 12 months. We used structural equation models to estimate the contribution of mediators. All models were tested for goodness-of-fit using χ , Root Mean Square Error of Approximation, Adjusted Goodness of Fit Index, and Bentler Comparative Fit Index. RESULTS We included 701 adults with LBP. The average RMDQ score at baseline for those on the intervention arm was 8.8 (Standard Deviation 5.0). The intervention was effective in reducing disability and pain at 12 months. Change in mental functioning was not a significant mediator. Changes to pain self-efficacy, fear avoidance, and physical functioning were causal mediators of the treatment effect at 12 months (RMDQ b= -0.149, P < 0.001; MVK-pain b = -0.181, P < 0.001 and MVK-disability b = -0.180, P < 0.001). Overall, the SEM model exceeded the threshold for acceptable goodness-of-fit. CONCLUSION Fear avoidance and self-efficacy were important causal mediators of the cognitive behavioral treatment effect. Self-assessed change in physical function was a causal mediator but mental functioning was not. This suggests people need to experience meaningful change in physical function and beliefs but not in mental functioning associated with LBP, to achieve a treatment benefit. LEVEL OF EVIDENCE 2.