Status:
COMPLETED
Feasibility of n-of-1 Trials - a Pilot Study
Lead Sponsor:
University of Bristol
Conditions:
Osteoarthritis
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The aim of this study was to provide essential pilot data on the feasibility of conducting n-of-1 trials within secondary care within the UK, notably to: test the process of recruitment and design asp...
Detailed Description
Whilst the large scale randomised controlled trial (RCT) remains the scientific "gold standard" for evaluating therapies in clinical medicine, the assumption made, that the treatment effect demonstrat...
Eligibility Criteria
Inclusion
- Patients attending clinics in the North Bristol Health Care Trust, with confirmed OA of the knee (Kellgren-Lawrence radiographic score of 2-4 within the previous 12 months) and use-related pain.
Exclusion
- Patients who had received corticosteroid injections or operations on their knee in the previous six months were excluded. Those with known contraindications to paracetamol or any NSAID, and those taking steroids, warfarin or aspirin for another medical condition were excluded from the drug trials.
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00371696
Start Date
December 1 2001
End Date
December 1 2003
Last Update
September 4 2006
Active Locations (1)
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1
Southmead Hospital
Bristol, United Kingdom, BS20 5NB