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].
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.


CONCLUSIONS
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.
Cross
Pamela L
PL
Centre for Health Sciences, Barts and The London, Queen Mary's School of Medicine and Dentistry, Whitechapel, London E1 2AT, UK. p.l.cross@qmul.ac.uk
Ashby
Deborah
D
Harding
Geoff
G
Hennessy
Enid M
EM
Letley
Louise
L
Parsons
Suzanne
S
Spencer
Anne E
AE
Underwood
Martin
M
D000284:Administration, Oral; D000287:Administration, Topical; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D002908:Chronic Disease; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D007717:Knee; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000523:psychology; D017060:Patient Satisfaction; D011320:Primary Health Care
D018712:Analgesics, Non-Narcotic; D007052:Ibuprofen