None listed
Conditions
Brief summary
Aim: To assess, using a parallel-group randomized controlled design, the effect of topical Diprosone OV ointment administered 3 times daily compared to placebo in reducing pain and improving function in participants with hand osteoarthritis over 6 weeks. Hypothesis: Topical Diprosone OV ointment administered 3 times daily would be more effective than placebo in reducing pain (visual analogue scale) and improving function (assessed using validated questionnaires and grip strength) in participants with hand osteoarthritis over 6 weeks.
Interventions
Topical Diprosone OV (betamethasone dipropionate in Optimised Vehicle) ointment, one pea-sized amount per joint, 3 times per day to the study joints (defined as the hand joints with pain level of at least 40 on a 100 mm visual analogue scale as assessed at baseline) for 6 weeks.
The remaining ointment will be weighed at the end of the study to assess the adherence to the ointment.
Sponsors
Flavia Cicuttini
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants aged >40 years with symptomatic radiological hand osteoarthritis; 2. Pain score of at least 40 on a 100 mm visual analogue scale and radiological OA (Kellgren and Lawrence grade >=2) in >=1 joint; 3. Stable analgesic requirements (including non-steroidal anti-inflammatory drugs) for at least 4 weeks, stable doses of chondroitin or glucosamine for 4 months, no corticosteroids via any route for at least 3 months.
Exclusion criteria
1. Concomitant rheumatic disease, inflammatory joint disease, psoriatic arthritis, ankylosing spondylitis, or gout; 2. Allergic reaction to other medicines containing betamethasone dipropionate, any other corticosteroid(s), or any of the ingredients of Diprosone OV ointment (i.e. betamethasone as dipropionate, propylene glycol, white beeswax, propylene glycol monostearate, and soft white paraffin); 3. Contraindication to topical corticosteroids (e.g. untreated bacterial, fungal, or viral skin lesions; widespread plaque psoriasis; skin conditions with ulcers); 4. Unable to complete informed consent; 5. Pregnancy, breast feeding, or trying to become pregnant.
Outcome results
None listed