Despite evidence that topical non-steroidal anti-inflammatory drugs (NSAIDs) and capsaicin are effective in osteoarthritis (OA), it is still unclear why they work for some people but not others. The investigators are undertaking an individual patient data (IPD) meta-analysis to identify responders according to patient characteristics, however, no studies report the presence of synovial hypertrophy or neuropathic-like pain. These two traits are of interest as they may be used to optimise the treatment effects of the two drugs which work via different mechanisms to reduce pain in OA. The investigators are therefore conducting this pilot n-of-1 trial series. This pilot n-of-1 trial series will investigate whether a person with OA, who has a different balance between inflammatory and neuropathic pain, shows a preference between these mechanistically different treatments. The trial will also be used to offer recommendations on the use of n-of-1 trial series for individualised (precision) medicine in OA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
22
Applied four times daily
Applied four times daily
Academic Rheumatology, University of Nottingham
Nottingham, Nottinghamshire, United Kingdom
Change from baseline knee pain on 0-10 numeric rating scale (NRS)
Pain experienced in the most painful knee in the past week will be recorded. The following question will be asked for this purpose: "In the past week, on average, how intense was your knee pain rated on a 0-10 scale, where 0 is 'no pain' and 10 is 'pain as bad as could be'?". The change in pain score between period baseline and period end will be calculated
Time frame: Baseline and end of each treatment period (i.e., after four weeks of treatment)
End-of-cycle treatment preference
"Considering only the pain relief experienced in this most recent cycle, which treatment do you feel provided satisfactory pain relief?"
Time frame: At the end of each treatment cycle (i.e., after 4 weeks of NSAID and 4 weeks of capsaicin).
End-of-study overall treatment preference
"Considering all the aspects of the treatment, including its effectiveness and ease of application, which treatment do you prefer?"
Time frame: At study completion - following six treatment periods (24 weeks of treatment, excluding washouts) or 4 treatment periods for responders at the interim analysis (16 weeks of treatment, excluding washouts)
Weekly knee pain on 0-10 numeric rating scale (NRS)
Pain experienced in the most painful knee in the past week will be recorded. The following question will be asked for this purpose: "In the past week, on average, how intense was your knee pain rated on a 0-10 scale, where 0 is 'no pain' and 10 is 'pain as bad as could be'?".
Time frame: At end of week 1, week 2, week 3, and week 4 of each treatment period.
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