Abstract
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
Highlights
Introduction to low back pain (LBP) modelPain fluctuationsOveractivity/underactivity cycle explained Use of pacingGroup problem solving for a specific task that tends to be ‘overdone’ e.g. gardeningWorking out starting point for exercises or activitiesHow to use baseline setting How to set goalsSMART system used to break down an example goalFeedback from group on how progressing with goals from assessmentGroup problem-solving problems with goalsUnhelpful thoughts and feelings
In the absence of published guidance, we defined compliance as attendance at the assessment session plus three of the six group sessions as we hypothesised that this would enable the key components of the cognitive behavioural intervention to be delivered, not necessarily reenforced
Statistical analysis We examined the baseline characteristics of participants randomised to the cognitive behavioural intervention (CBI) arm, by compliance status
Summary
Introduction to LBP modelPain fluctuationsOveractivity/underactivity cycle explained Use of pacingGroup problem solving for a specific task that tends to be ‘overdone’ e.g. gardeningWorking out starting point for exercises or activitiesHow to use baseline setting How to set goalsSMART system used to break down an example goalFeedback from group on how progressing with goals from assessmentGroup problem-solving problems with goalsUnhelpful thoughts and feelings. Group 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. We specified a priori that compliance was likely to be an important contributor to the effect of group cognitive behavioural therapy, and designed a trial that was sufficiently pragmatic to allow estimation of these effects in a generalizable sample and range of settings [2]. In the original intention-to-treat analysis, we demonstrated that group cognitive therapy was effective at and beyond 12 months in a range of clinically relevant outcome measures, with standardised effect sizes mostly in the moderate range [3,4]
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