None listed
Conditions
Brief summary
This randomised control trial will compare the effects of topical non-steroidal anti inflammatory drug (NSAID) to a sham topical gel in people with painful foot osteoarthritis (OA). The primary objective is to determine whether daily use of a topical NSAID gel leads to significantly greater reductions in foot OA pain with walking, compared to a sham gel, at 6 weeks. The secondary objectives are to determine whether daily use of a topical NSAID gel leads to significantly greater benefits on other clinical outcomes (physical function, other measures of foot OA pain, global ratings of change, health-related quality of life, and physical activity levels), compared to a sham gel, at 6 weeks, and evaluate the extent of use and clinical outcomes in a subsequent 6 week follow up period when use was deemed as needed, at 12 weeks.
Interventions
The intervention group will receive three 120g tubes of 23.2mg/g diclofenac gel. They will be instructed to apply a small amount gel (2g; approximately 5 cent piece size) to the painful area and rub it in until it has been absorbed, twice per day for 6 weeks. In the subsequent 6 weeks they will be advised that they may continue to use their allocated gel up to twice a day as needed on a symptomatic basis after the 6 week primary timepoint has been completed. Adherence will be monitored by the us
The intervention group will receive three 120g tubes of 23.2mg/g diclofenac gel. They will be instructed to apply a small amount gel (2g; approximately 5 cent piece size) to the painful area and rub it in until it has been absorbed, twice per day for 6 weeks. In the subsequent 6 weeks they will be advised that they may continue to use their allocated gel up to twice a day as needed on a symptomatic basis after the 6 week primary timepoint has been completed. Adherence will be monitored by the use of daily logbooks.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i) aged >45 years, ii) report foot pain in the first metatarsophalangeal joint and/or midfoot on most days of the month for the past 12 weeks, iii) report a minimum foot pain score of 4 on an 11-point numerical rating scale during walking over the previous week, iv) evidence of radiographic OA (a score of 2 or more for osteophytes or joint space narrowing according to a radiographic atlas) in either the first metatarsophalangeal joint and/or midfoot joints (the first cuneometatarsal (CM1) joint, the second CM (CM2) joint, the navicular–first cuneiform (N-1st C) joint, and the talonavicular (TN) joint), and v) report either no morning joint-related stiffness in the big toe/midfoot joints, or morning stiffness that lasts no longer than 30 minutes.
Exclusion criteria
i) previous foot joint surgery or planned foot surgery on the affected side in the next 12 weeks, ii) current use of any oral or topical anti-inflammatory medication for any condition (past 6 weeks), iii) current contraindication to using topical anti-inflammatory medication (e.g., aspirin, allergy, anticoagulant use, salicylates, 3rd trimester of pregnancy, kidney problems, abdominal pain), iv) had any foot joint injections on the affected side in the past 6 months or planned foot injections in next 12 weeks, v) self-report any other current muscular, joint or neurological condition affecting lower limb function to such an extent that they are housebound or non-ambulant, vi) pain in another foot or ankle location that is greater than the pain in the study foot joint, vii) self-report any systemic or inflammatory joint disease (e.g., rheumatoid arthritis), viii) moderate to severe hallux valgus based on a hallux abductus angle greater than 20 degs on x-ray, ix) current (past 6 weeks) or planned use of a gait aid in the next 12 weeks, x) current (past 6 weeks) or planned treatment with a health professional for their foot joint OA in the next 12 weeks, xi) inability to understand written/spoken English, xii) unable to commit to study requirements (e.g., attending x-rays, using gel, completing outcomes, unable to reach feet), xiii) previously participated in a CHESM clinical trial in the prior four years, or currently participating in another research study at CHESM or elsewhere.
Outcome results
None listed