Elsevier

The Lancet

Volume 375, Issue 9718, 13–19 March 2010, Pages 916-923
The Lancet

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

https://doi.org/10.1016/S0140-6736(09)62164-4Get rights and content

Summary

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, and the probability of cost-effectiveness was greater than 90% at a threshold of £3000 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.

Introduction

Low-back pain is consistently among the top six most costly health problems and, accounting for incidence, one of the top three most disabling conditions in developed countries.1 International guidance recommends that people with persistent non-specific low-back pain remain physically active.2, 3 Advice to remain active, delivered by a nurse, is superior to normal care provided in general practice,4 but has a short-lived effect.5 Compared with advice to remain active, physical treatments (structured exercise, acupuncture, manipulation, and postural approaches) produce small to moderate mean short-term (≤4 months) benefits, but typically small or non-significant mean longer-term (≥12 months) benefits.3, 4, 6, 7, 8

Recent UK guidance provides the most comprehensive systematic reviews of treatments for low-back pain, but was unable to draw conclusions about the value of psychological treatments because of a paucity of definitively sized trials with long-term follow-up.3 There is some proof of concept to support cognitive behavioural interventions, but trials that tracked response beyond 6 months reported mixed results.9, 10, 11 Guided discovery is the key clinical skill needed to elicit and challenge beliefs in cognitive behavioural intervention, and is accompanied by education in skills such as pacing and goal setting.9, 10, 11 Cognitive behavioural interventions can be delivered on an individual basis or in a group. Groups have the advantage of participants being able to interact with others with similar problems and are attractive since unit-costs of delivery can be very competitive.9

Our aim was to estimate the effectiveness and cost-effectiveness of a group cognitive behavioural intervention in addition to best practice advice over 1 year in people with at least moderately troublesome subacute or chronic low-back pain in primary care.

Section snippets

Participants

The Back Skills Training Trial was a pragmatic, multicentre, randomised controlled trial. We recruited participants from 56 general practices in seven regions across England, including some practices from the Medical Research Council (MRC) General Practice Research Framework. Participants were identified from consultations with family doctors or practice nurses, and from searches of patient records. Patients were eligible for inclusion if they were aged 18 years or older, had at least

Results

Figure 1 shows the trial profile. 701 participants were randomised and provided baseline data between April, 2005, and April, 2007 (control, n=233; advice plus cognitive behavioural intervention, n=468). Table 1 shows baseline characteristics of the study participants. The most frequent presentation was moderately troublesome daily pain in the back and buttocks, together with stiffness and restricted range of motion. The mean age of participants was 54 years (range 18–85 years), and 60% (420 of

Discussion

Effective treatments that result in sustained improvements in low-back pain are elusive. This trial shows that a bespoke cognitive behavioural intervention package, BeST, is effective in managing subacute and chronic low-back pain in primary care. The short-term effects (≤4 months) are similar to those seen in high-quality studies and systematic reviews of manipulation, exercise, acupuncture, and postural approaches in primary care.4, 6, 7 Unlike many of these other treatments, the benefits of

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