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

Phase

N/A

Condition

Fever

Osteoarthritis

Pain

Treatment

Knee Heatwraps

Clinical Study ID

NCT06650631

161(B)MD22324

Ages 19-69
All Genders

Study Summary

This post-market clinical follow-up, open-label, multicenter clinical investigation is designed to investigate the effectiveness, safety and tolerability of ThermaCare® Knee Heatwraps in the painful knee joint due to osteoarthritis. Approximately 80 patients, 19-69 years old inclusive, with moderate knee osteoarthritis (without acute flares or inflammation) will be enrolled. The overall duration of the investigation is expected to be 11 days, including screening days. The maximum treatment duration for each patient is 7 days (8h/d).

Eligibility Criteria

Inclusion

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 theclinical investigation.
Patient with diagnosis of mono or bilateral moderate knee osteoarthritis with kneepain intensity > 40 mm on a 0-100 mm VAS, able to independently ambulate withoutwalking 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 apregnancy from the signature of the informed consent up to the final visit

Exclusion

Exclusion Criteria:

Clinically significant abnormal physical findings which could interfere with theobjectives of the investigation
History of anaphylaxis to drugs or allergic reactions in general, which could affectthe outcome of the clinical investigation.
Significant history of diseases that may interfere with the aim of the clinicalinvestigation.
History of (in the last 6 months) or ongoing intra-articular injection involving theselected 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 theapplication area.
Surgery at the selected knee in the 12 months preceding the clinical investigation.
Any medication that could interfere with the investigation procedures orinvestigation 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 arerelevant to the decision to participate, or who could be manipulated or undulyinfluenced because of a compromised position, expectation of benefits or fear ofretaliatory response.

Study Design