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

Not Applicable

• Conditions: Hand osteoarthritis; Musculoskeletal - Osteoarthritis; Anaesthesiology - Pain management

• Registration Number: ACTRN12622000111774
• Lead Sponsor: niversity of Canberra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-24
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain (Visual Analogue Scale)[Before + After breakfast each day<br>Average pain from days 1-3<br>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 Measures

Name	Time	Method
Quality of life (5 level & dimensional EQoL)[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.<br>];Hand Function (AIMS2)[Baseline to day 7. This will be measured once at baseline and once more on Day 7.]