Fibromyalgia is a common chronic pain pathology with an incidence of 4.3 per 1,000 person-years. An open, randomized clinical trial of patients with fibromyalgia comparing an immediate vs. delayed 18-day spa therapy in five spa therapy care facilities in France enrolled 220 patients. Randomization was in blocks of four, stratified by center, severity of fibromyalgia and previous spa therapy. Patients continued usual treatment. The main endpoint was the number of patients achieving minimal clinically important difference at 6 months, defined as 14% change in their baseline fibromyalgia impact questionnaire score. The intention-to-treat analysis included 100 and 106 patients in the intervention and control groups, respectively. At 6 months, 45/100 (45.0%) and 30/106 (28.3%) patients in the intervention and control groups, respectively, achieved a minimal clinically important difference (P= .013). There was also a significant improvement in pain, fatigue, and symptom severity (secondary outcomes) in the intervention group but not for generic quality of life (QOL), sleep or physical activity. None of the 33 serious adverse events reported by 25 patients were related to the spa therapy. Our results demonstrate the benefit of spa treatment in patients with fibromyalgia. PERSPECTIVE: A 12-month, open, randomized clinical trial of 220 patients with fibromyalgia compared an immediate versus delayed (ie, after 6 months) 18-day spa therapy. The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02265029.
Access to such modalities is one of the lapses in the American Health Care system. So this article provides insights but also adds to the frustration with which US doctors must function.
The open-label trial design makes it difficult to ascertain the trial result.
This open label randomised trial of an 18 day spa treatment in patients with Fibromyalgia suggests that spa therapy offers significant benefits for Fibromyalgia patients for a number of outcome measures which is present at 6 month follow up and persists to a lesser degree at 12 month follow up. However there is no discernible benefit for quality of life, sleep or physical activity all of which are important outcomes in patients with Fibromyalgia. The open nature of the trial, small participant numbers and the potential biases both from participants and the trial personnel, given the setting of the trial in spa centres, suggests that the role of spa therapy in the long term management of Fibromyalgia patients remains uncertain.