Ultrasonography as an Evaluation Tool in a Randomized Controlled Trial Assessing Balneotherapy Effects in Rheumatoid Arthritis

Abstract

Objective: To evaluate the usefulness of ultrasonography as an evaluation tool in a Randomized Controlled Trial assessing Balneotherapy effects in Rheumatoid Arthritis. Methods: A prospective controlled clinical trial, not blinded, randomly assigned of patients with rheumatoid arthritis accordingly to the American College of Rheumatology criteria. The Balneotherapy group received Balneotherapy’s throughout 21 days in S. Jorge Spa. The main outcome was hand/wrist ultrasonography measured at the same moments in the two groups, and McNemar’s tests were used to compare changes in ecographics signals, with a 5% statistical significance level. Secondary outcomes were taken at same time for HAQ-DI and DAS28. A moderated regression analysis, complemented with the Johnson-Neyman (J-N) technique was used to perform the statistical analysis. Results: In thermal group there was a statistically significant result (p < 0.05) regarding the evolution of synovitis only at left hand/wrist according to ultrasonography signals, between baseline and day 21, end of thermal treatment, and after 3 months. Curiously, the same statistical findings were found in the control group, but at right side. No difference was found in DAS28 at the end of Balneotherapy but almost reach significance at month 3. HAQ-DI at end of treatment and 3rd month follow-up was significantly improved in the Balneotherapy. Conclusions: Pain and diminished function are hallmarks of RA patients, so any complementary contribution with no or mild side effects, as Balneotherapy, is welcome to enhance quality of life. In this study ultrasonography could detect improvement in synovitis in both RA patients groups, Balneotherapy translating both the possible effect of treatment and the natural history of RA. Both joints were the more affected at enrolment and the Balneotherapy had a slightly higher DAS28. Quality of life had a sustainable improvement with Balneotherapy. Ultrasonography is an objective, inexpensive modality to measure the response of RA small joint synovitis to Balneotherapy, provided that it is realized by a medical doctor with specific formation.