Gravesano

Researchers are evaluating the use of ThermaCare4 Knee Heatwraps to treat knee pain caused by moderate osteoarthritis in adults aged 19 to 69 years. This open-label, multicenter clinical investigation focuses on the device's effectiveness, safety, and tolerability for patients without acute flares or inflammation in the knee. About 80 participants will be enrolled to assess pain relief over a short-term period. Participants will use the ThermaCare Knee Heatwraps as instructed, applying the device to the painful knee joint for up to 8 hours per day. The maximum treatment duration is 7 days, and the overall study lasts approximately 11 days including screening. The study involves one treatment group using the heatwrap device as a post-market evaluation. During the study, patients will report their pain intensity at home daily from Day 1 to Day 4. Researchers will monitor safety, tolerability, and adherence to the treatment instructions. The study includes screening procedures such as radiography of the knee within the last 6 months and assessments of pain levels. Follow-up visits and evaluations will ensure proper monitoring throughout the study period.