Abstract
Evidence of symptomatic treatment for fibromyalgia (FM) is very low. Whole body cryotherapy (WBC) modulates different neurotransmitters, which might have a role in pain alleviation and could exert an effect on FM. Our aim was to evaluate the efficacy of WBC for the control of pain and impact of disease in FM. For this we run an open, randomized, crossover trial of Cryosense TCT™ cabin vs rest. Patients with FM according to ACR criteria were recruited consecutively from general practices. Trial endpoints were change (∆) in pain after 2 and 4 weeks, measured by a visual analogue scale (VAS), ∆ burden of disease, evaluated by the Fibromyalgia Impact Questionnaire (FIQ), and severity of FM, measured by the Combined Index of Severity of Fibromyalgia (ICAF). Within group differences, sequence and period effects were tested with Student’s t or Mann–Whitney U tests. Multiple linear regression models were used to adjust effect by baseline differences between groups. Sixty patients were included in the trial. A period effect was noted, with residual effect of WBC; therefore, only results from the first sequence were analysed. ∆VAS pain, ∆FIQ and ∆ICAF scores were significantly larger in the WBC group after the first period (3.0 vs 0.3 in ∆VAS pain; 32.1 vs 0.4 in ∆FIQ; 13.7 vs 0.07 in ∆ICAF; all p < 0.001), and were confirmed after adjustment. In conclusion, WBC with a Cryosense TCT cabin may be a useful adjuvant therapy for FM; further studies on long-term effect and compared to other physical therapies are warranted.Trial registration NCT03425903.
Highlights
Fibromyalgia (FM) is a syndrome characterised by chronic generalized musculoskeletal pain, hyperalgesia, and allodynia
visual analogue scale (VAS) pain at visit 4, after washout, showed a significant difference between groups with lower values in the Whole body cryotherapy (WBC) group compared to control (5.0 vs 6.5; p = 0.013), which reflects a residual effect of therapy
A period effect was observed with significant differences between the responses of the first and second period in the main outcome measures: VAS pain (p = 0.015) and total Fibromyalgia Impact Questionnaire (FIQ) (p value = 0.003)
Summary
Fibromyalgia (FM) is a syndrome characterised by chronic generalized musculoskeletal pain, hyperalgesia, and allodynia. There are several drugs and other non-pharmacological measures available for the management of fibromyalgia, at present there is no a definitive cure. Experts recommend to focus on patient education and non-pharmacological alternatives as initial management, followed by tailored psychological therapies, analgesic or sleep modulating remedies, or multimodal rehabilitation in the last step [12]. Due to the limited efficacy of the therapeutic options, patients usually seek help in alternative therapies, like acupuncture, biofeedback, chiropractic, hypnosis, transcranial direct current stimulation, etc. [5, 12, 13]
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