Study Summary

217 patients with severe knee osteoarthritis were randomized to receive medical mud-pack therapy applied bilaterally at 39 °C, 42 °C, or 45 °C. All patients received 30-minute treatment sessions over 12 consecutive weekdays. The primary outcome of interest was achievement of minimal clinically important improvement in pain (VAS), patient global assessment, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale. Secondary outcomes included VAS pain, patient and physician global assessments, WOMAC total and function scores, patient health state, and Patient Acceptable Symptom State. Outcomes were assessed at baseline and at the end of treatment. Overall, the results of the study revealed that medical mud-pack therapy at 42 °C and 45 °C resulted in significantly greater clinically important improvements in pain and function than therapy at 39 °C, with no meaningful differences between the two higher-temperature regimens.