What is this study trying to find out about osteoarthritis knee pain?

This study is evaluating how well ThermaCare Knee Heatwraps work for managing pain in people with moderate knee osteoarthritis. Researchers want to understand the safety and tolerability of this heat treatment. The trial is sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A and includes patients aged 19 to 69 with moderate knee pain.

Who may be eligible for this osteoarthritis clinical trial?

Adults aged 19 to 69 with moderate knee osteoarthritis and knee pain above 40 mm on a pain scale may be eligible. Both men and women can participate if they can walk without assistance and meet other health criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this osteoarthritis clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for their own travel costs if needed.

Actively Recruiting

Phase Not Applicable

Age: 19Years - 69Years

All Genders

ID06650631

International Study on the Safety and Effectiveness of ThermaCare Knee Heatwraps for Treating Pain in Adults with Moderate Knee Osteoarthritis

Led by Aziende Chimiche Riunite Angelini Francesco S.p.A · Updated on 2025-09-08

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and tolerability of ThermaCare4 Knee Heatwraps for treating knee pain due to moderate osteoarthritis in adults aged 19 to 69. This international, open-label, post-market clinical investigation involves about 80 patients without acute flares or inflammation. The study aims to better understand how heat treatment may help manage painful knee joints in this population. Participants will use the Knee Heatwraps according to the device instructions for up to 7 days, wearing them for 8 hours each day. The study includes a total duration of 11 days, which covers screening and treatment periods. The investigation is conducted across multiple centers and involves only one treatment group. During the study, participants will report pain intensity at home from Day 1 to Day 4 and continue pain assessments through Day 7. Researchers will also evaluate sensory perceptions shortly after application on Day 1, functional levels, joint health, and overall health status at the final visit on Day 8. Safety evaluations will be conducted throughout the study period. Participants will attend scheduled visits and provide feedback on their knee pain and function throughout the trial.

CONDITIONS

Brief Title

The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinical Investigation

Who Can Participate

Age: 19Years - 69Years

All Genders

Eligibility Criteria

You may qualify if you...

Signed written informed consent before joining the study.
Any gender and ethnic origin, aged 19 to 69 years inclusive.
Body Mass Index between 18.5 and 40 kg/m2 inclusive.
Ability to fully understand the study purpose and procedures.
Diagnosed with moderate knee osteoarthritis with pain over 40 mm on a 0-100 mm pain scale.
Able to walk independently without a walking aid.
Have a knee X-ray no older than 6 months.
Not able to become pregnant or agree not to start pregnancy during the study period.

You will not qualify if you...

Any significant abnormal physical findings that may affect study results.
History of severe allergic reactions or anaphylaxis.
Serious diseases that could interfere with the study goals.
In the last 6 months, or ongoing, steroid injections or physical therapy in the knee.
Signs of flares, inflammation, swelling, or effusion in the knee.
Any skin injury, rash, irritation, sores, or discoloration where the heatwrap would be applied.
Knee surgery within the past 12 months.
Use of medications or other hot/cold therapies that may affect study outcomes.
Positive pregnancy test, pregnancy, or breastfeeding.
History of drug or alcohol abuse in the past 12 months.
Inability to fully understand or voluntarily consent to the study participation.

Research Team

Rosita Molinario

Enrica Salvatori

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International Study on the Safety and Effectiveness of ThermaCare Knee Heatwraps for Treating Pain in Adults with Moderate Knee Osteoarthritis

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria