None listed
Conditions
Brief summary
This study will be conducted as an online trial. All treatment packages will be shipped to the participant's postage address. Recruitment, and treatment application will be conducted in the participant's residence. This trial will evaluate the effectiveness and safety of new gel (Soodox Active) to reduce pain in hand osteoarthritis. It will be compared to another gel (Voltaren) that is widely used in current practice for a range of pain types and is considered the gold-standard commercial product. The effects on pain will then be measured in both using a 0-100mm Visual Analogue Scale, 100 being the worst pain and 0 being no pain. The participant's quality of life and hand function will also be measured using standardised questionnaires.
Interventions
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
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.
Sponsors
University of Canberra
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
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
1. Allergies to NSAIDs or any of either of the gel’s ingredients 2. Inflamed or broken skin in area to be treated 3. Signs or symptoms of systemic infection (such as fever, and chills, nausea and vomiting, blotchy or discoloured skin, weakness, or diarrhoea) as this is not indicated for local osteoarthritis pain 4. Systemic conditions (i.e. rheumatoid arthritis, Buerger’s disease, mucous cyst, dactylitis, pyogenic granuloma) and/or taking anti-rheumatic drugs (i.e. methotrexate, cyclosporine) 5. Autoimmune diseases: lupus, multiple sclerosis 6. Have chronic kidney disease/acute kidney injury 7. Use of non-prescription topical or oral analgesic treatment within the last 48 hours 8. Current use of a prescription topical or oral analgesic treatment and unable to stop this for the duration of the trial 9. History of stomach ulcers 10. Asthma 11. Anticoagulation/antithrombotic therapies such as aspirin and warfarin 12. Antidepressant therapies such as Sertraline (Zoloft), citalopram, fluoxetine and paroxetine 13. Taking blood pressure medications 14. Acute injury or trauma to either hand in the previous 2 months 15. Anyone with loss of sensation in their hands 16. Pregnancy 17. Scheduled surgery within 2 weeks as there may be a low risk for post-operative bleeding.
Outcome results
None listed