Study protocol

TOIB Study. Are topical or oral ibuprofen equally effective for the treatment of chronic knee pain presenting in primary care: a randomised controlled trial with patient preference study. [ISRCTN79353052]

Pamela L Cross¹ , Deborah Ashby³ , Geoff Harding¹ , Enid M Hennessy³ , Louise Letley² , Suzanne Parsons¹ , Anne E Spencer⁴ and Martin Underwood¹ for the TOIB Study Team^1,2,3,4

¹Centre for Health Sciences, Barts and The London, Queen Mary's School of Medicine and Dentistry, 2 Newark Street, Whitechapel, London E1 2AT, UK

²Medical Research Council General Practice Research Framework, Stephenson House, North Gower St, London NW1 2ND, UK

³Wolfson Institute of Preventive Medicine, Barts and The London, Charterhouse Square, London EC1M 6BQ, UK

⁴Department of Economics, Queen Mary's University of London, Mile End Road, London E1 4NS, UK

author email corresponding author email

BMC Musculoskeletal Disorders 2005, 6:55doi:10.1186/1471-2474-6-55

Published:	7 November 2005

Abstract

Background

Many older people have chronic knee pain. Both topical and oral non- steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat this. Oral NSAIDS are effective, at least in the short term, but can have severe adverse effects. Topical NSAIDs also appear to be effective, at least in the short term. One might expect topical NSAIDs both to be less effective and to have fewer adverse effects than oral NSAIDs. If topical NSAIDs have fewer adverse effects this may outweigh both the reduction in effectiveness and the higher cost of topical compared to oral treatment. Patient preferences may influence the comparative effectiveness of drugs delivered via different routes.

Methods

TOIB is a randomised trial comparing topical and oral ibuprofen, with a parallel patient preference study. We are recruiting people aged 50 or over with chronic knee pain, from 27 MRC General Practice Research Framework practices across the UK. We are seeking to recruit 283 participants to the RCT and 379 to the PPS. Participants will be followed up for up to two years (with the majority reaching one year). Outcomes will be assessed by postal questionnaire, nurse examination, laboratory tests and medical record searches at one and two years or the end of the study.

Discussion

This study will provide new evidence on the overall costs and benefits of treating chronic knee pain with either oral or topical ibuprofen. The use of a patient preference design is unusual, but will allow us to explore how preference influences response to a medication. In addition, it will provide more information on adverse events. This study will provide evidence to inform primary care practitioners, and possibly influence practice.