Gravesano

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.