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Open Access Study protocol

A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol

Elaine M Hay, Kate M Dunn*, Jonathan C Hill, Martyn Lewis, Elizabeth E Mason, Kika Konstantinou, Gail Sowden, Simon Somerville, Kanchan Vohora, David Whitehurst and Chris J Main

Author Affiliations

Arthritis Research Campaign National Primary Care Centre, Primary Care Sciences, Keele University, Staffordshire, ST5 5BG, UK

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BMC Musculoskeletal Disorders 2008, 9:58  doi:10.1186/1471-2474-9-58

Published: 22 April 2008

Abstract

Background

Back pain is a major health problem and many sufferers develop persistent symptoms. Detecting relevant subgroups of patients with non-specific low back pain has been highlighted as a priority area for research, as this could enable better secondary prevention through the targeting of prognostic indicators for persistent, disabling symptoms. We plan to conduct a randomised controlled trial to establish whether subgrouping using a novel tool, combined with targeted treatment, is better than best current care at reducing long-term disability from low back pain.

Methods/Design

We will recruit 800 participants aged 18 years and over with non-specific low back pain from 8–10 GP practices within two Primary Care Trusts in Staffordshire, England. Our primary outcome measures are low back pain disability and catastrophising. Secondary outcomes include back pain intensity, global change, leg pain, fear avoidance, anxiety, depression, illness perceptions, patient satisfaction, overall health status and cost-effectiveness. Data will be collected before randomisation, and 4 and 12 months later. Participants are randomised to receive either newly developed interventions, delivered by trained physiotherapists and targeted according to subgroups defined by tool scores, or best current care.

Discussion

This paper presents detail on the rationale, design, methods and operational aspects of the trial.

Trial registration

Current Controlled Trials ISRCTN37113406.