Heat treatment for knee pain in osteoarthritis patients
The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation. Prospective, Open-label, One-arm, Post-market, Effectiveness Clinical Investigation
NA · Aziende Chimiche Riunite Angelini Francesco S.p.A · NCT06650631
This study is testing if wearing ThermaCare® Knee Heatwraps can help people with knee pain from osteoarthritis feel better and move more easily.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 19 Years to 69 Years |
| Sex | All |
| Sponsor | Aziende Chimiche Riunite Angelini Francesco S.p.A (industry) |
| Locations | 1 site (Gravesano, Switzerland) |
| Trial ID | NCT06650631 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the effectiveness, safety, and tolerability of ThermaCare® Knee Heatwraps in patients suffering from knee pain due to osteoarthritis. Approximately 80 participants aged 19-69 with moderate knee osteoarthritis will be enrolled in this open-label, multicenter study. The treatment involves wearing the heatwraps for up to 8 hours a day over a maximum duration of 7 days. The study aims to assess pain relief and overall improvement in knee function.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 19-69 with moderate knee osteoarthritis and a pain intensity greater than 40 mm on a visual analog scale.
Not a fit: Patients with acute knee inflammation or those with significant comorbidities that may interfere with the study outcomes may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved mobility for patients with knee osteoarthritis.
How similar studies have performed: Other studies have shown positive outcomes with heat therapy for pain management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed written informed consent before inclusion in the investigation. * Any gender, any ethnic origin, 19-69 years old inclusive. * Body Mass Index 18.5-40 kg/m2 inclusive. * Full comprehension: ability to comprehend the full nature and purpose of the clinical investigation. * Patient with diagnosis of mono or bilateral moderate knee osteoarthritis with knee pain intensity \> 40 mm on a 0-100 mm VAS, able to independently ambulate without walking aid. * Availability of a radiography of the selected knee not older than 6 months. * Patient is either not of childbearing potential or must agree not to start a pregnancy from the signature of the informed consent up to the final visit Exclusion Criteria: * Clinically significant abnormal physical findings which could interfere with the objectives of the investigation * History of anaphylaxis to drugs or allergic reactions in general, which could affect the outcome of the clinical investigation. * Significant history of diseases that may interfere with the aim of the clinical investigation. * History of (in the last 6 months) or ongoing intra-articular injection involving the selected knee. History of ongoing physical therapy involving the selected knee. * Presence of flares, inflammation, effusion and swelling at the selected knee. * Any skin injury, wound, irritation, rash, bump, sore and/or discoloration at the application area. * Surgery at the selected knee in the 12 months preceding the clinical investigation. * Any medication that could interfere with the investigation procedures or investigation outcome. * Use of other hot or cold therapies for the selected knee. * Positive pregnancy test at screening; pregnant or breastfeeding women * History of (within the past 12 months) or current drugs or alcohol abuse * Individuals unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response.
Where this trial is running
Gravesano, Switzerland
- Ars Medica Clinic — Gravesano, Switzerland, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Rosita Molinario
- Email: rosita.molinario@angelinipharma.com
- Phone: +39 3473243756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain Management, Osteoarthritis, Pain, ThermaCare®, Medical Device