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Open Access Study protocol

Testing the credibility, feasibility and acceptability of an optimised behavioural intervention (OBI) for avoidant chronic low back pain patients: protocol for a randomised feasibility study

Tamar Pincus1*, Shamaila Anwar2*, Lance McCracken3, Alison McGregor4, Liz Graham2, Michelle Collinson2, Amanda J Farrin2 and on behalf of the OBI Trial Management Team

Author Affiliations

1 Department of Psychology, University of London, Royal Holloway, Egham, Surrey TW20 0EX, UK

2 Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK

3 Health Psychology Section, Psychology Department, King’s College, 5th Floor Bermondsey Wing Guy’s Campus, London SE1 9RT, UK

4 Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Charing Cross Hospital, London W6 8RF, UK

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Trials 2013, 14:172  doi:10.1186/1745-6215-14-172

Published: 13 June 2013

Abstract

Background

Chronic back pain continues to be a costly and prevalent condition. The latest NICE guidelines issued in 2009 state that for patients with persistent back pain (of between six weeks and twelve months duration), who are highly distressed and/or disabled and for whom exercise, manual therapy and acupuncture has not been beneficial, the evidence supports a combination of around 100 hours of combined physical and psychological treatment. This is costly, and may prove unacceptable to many patients. A key recommendation of these guidelines was for further randomised controlled trials (RCTs) of psychological treatment and to target treatment to specific sub-groups of patients. Recent trials that have included psychological interventions have shown only moderate improvement at best, and results are not maintained long term. There is therefore a need to test theoretically driven interventions that focus on specific high-risk sub-groups, in which the intervention is delivered at full integrity against a credible control.

Methods/design

A feasibility study of a pragmatic randomised controlled trial comparing psychologist-delivered Contextual Cognitive Behavioural Therapy (CCBT) against Treatment As Usual (TAU) physiotherapy delivered by physiotherapists for the treatment of chronic lower back pain in ‘avoidant’ patients. Ninety-two patients referred for physiotherapy will be recruited and randomised on a 1:1 basis to receive CCBT or TAU. Treatment groups will be balanced by centre and pain interference score. Primary outcomes include assessing the credibility and acceptability of the intervention, and to demonstrate proof of principle through a greater change in pain acceptance in the CCBT arm, measured by the Acceptance and Action –II and the Chronic Pain Acceptance questionnaires. In addition, the feasibility of carrying out a full trial will be explored with reference to recruitment and follow-up rates including the assessment of the burden of outcome measure completion. Secondary patient outcomes include disability, pain, fear of movement, mood, quality of life, and global recovery. Outcomes are measured at three and six months post-randomisation.

Discussion

This paper details the rationale, design, therapist training system and recruitment methods to be used in a feasibility study which will inform the design and efficient implementation of a future definitive RCT.

Trial registration

ISRCTN43733490

Keywords:
Low back pain; Psychology; Contextual Cognitive Behavioural Therapy; Fear avoidance