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.
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.
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.
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.
National Institute for Health Research Health Technology Assessment Programme.
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