Online clinical trial on a novel topical gel for hand osteoarthritis pain

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: Arm 1: The test product is a TGA‐approved (ARTG ID: 317968) pain‐relief cream, Soodox Active, developed by Eczanes Pharmaceuticals Pty Ltd. The product will be dispensed in one 25g tube per participant for home application. It's active ingredients include: arnica extract, rosemary oil, clove bud oil, emu oil. ˜2cm of the product will be applied topically on the hands 4 times p/day for 7 days Participant compliance to the treatment instructions will be assess objectively by weighing the tubes of gels prior to supply and at the end of treatment. Compliance will be measured subjectively when participants self‐report each application time. CONDITION: Anaesthesiology ‐ Pain management Hand osteoarthritis; ; Hand osteoarthritis Musculoskeletal ‐ Osteoarthritis PRIMARY OUTCOME: Pain (Visual Analogue Scale)[Before + After breakfast each day; Average pain from days 1‐3; Average pain from days 4‐7] Pain (Visual Analogue Scale)[Between‐groups difference in pain intensity change from pre‐application at baseline to 60 minutes after the day 7 application.] SECONDARY OUTCOME: Hand Function (AIMS2)[Baseline to day 7. This will be measured once at baseline and once more on Day 7.] Hand function (AUSCAN)[Baseline to day 7. This will be measured once at baseline and once more on Day 7. ; ] Quality of life (5 level & dimensional EQoL)[Baseline to day 7. This will be measured once at baseline and once more on Day 7.] INCLUSION CRITERIA: 1. Adults of any age over 18 years. 2. Have been diagnosed with hand osteoarthritis 3. Have at least two inter/distal phalangeal and/or one first carpometacarpal joint pain 4. Have at least two or three painful flare‐ups of pain in a finger joint during the previous 12 months 5. Discontinuation of all analgesic (prescription or over the counter) at least 3 days prior to first application. 6. Able and willing to provide informed consent
Epistemonikos ID: 1d9e1fa65af2d91ec3e3f47086a5b417e7d08f42
First added on: Aug 25, 2024