Articles www.thelancet.com Published online February 26, 2010 DOI:10.1016/S0140-6736(09)62164-4 1 Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis Sarah E Lamb, Zara Hansen, Ranjit Lall, Emanuela Castelnuovo, Emma J Withers, Vivien Nichols, Rachel Potter, Martin R Underwood, on behalf of the Back Skills Training Trial investigators* 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 recom- mends 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. 3,4,6–8 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. 9–11 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. 9–11 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. Published Online February 26, 2010 DOI:10.1016/S0140- 6736(09)62164-4 See Online/Comment DOI:10.1016/S0140- 6736(10)60277-2 *Members listed at end of paper Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK (Prof S E Lamb DPhil, Z Hansen MCSP, R Lall PhD, E Castelnuovo MSc, E J Withers, V Nichols MRes, R Potter MSc, Prof M R Underwood MD); and Kadoorie Critical Care Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK (Prof S E Lamb) Correspondence to: Prof Sarah E Lamb, Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK s.lamb@warwick.ac.uk