Dual-Site Transcranial Direct Current Stimulation Combined With Exercising Improves Fatigue and Sleep Quality in People With Fibromyalgia: A Randomized Sham-Controlled Clinical Trial.

Abstract

OBJECTIVE: The study aimed to evaluate the effectiveness of a combined program of unihemispheric concurrent dual-site anodal-transcranial direct current stimulation (UHCDS a-tDCS) + therapeutic exercise (TE) on fatigue and sleep quality in people with fibromyalgia syndrome (FMS). DESIGN: Double-blind, randomized, sham-controlled trial. SETTING: Primary health care center. PARTICIPANTS: A total of 90 volunteers diagnosed with fibromyalgia. Nine participants dropped out of the study. INTERVENTION: Participants were randomly allocated in a 1:1:1 ratio to active UHCDS a-tDCS+TE, sham UHCDS a-tDCS+TE, or control receiving TE. The intervention was delivered in 10 sessions over 6 weeks. OUTCOME MEASURES: Fatigue, sleep quality, and quality of life. RESULTS: Fatigue score decreased significantly in the active group compared with the sham (-9.8 points; 95% CI, -18.9 to -0.8; P=.028) and control groups (-9.9 points; 95% CI, -18.9 to -0.9; P=.027) at posttreatment and compared with the control group at follow-up (-11.5 points; 95% CI, -20.8 to -2.1; P=.01). Sleep quality improved in active group compared with sham and control groups at posttreatment (sham: -14.4 points; 95% CI, -24.2 to -4.5; P=.002; control: -19.5 points; 95% CI, -29.4 to -9.7; P<.001) and at follow-up (sham: -11.2 points; 95% CI, -21.1 to -1.3; P=.02; control: -15.5 points; 95% CI, -25.3 to -5.6; P<.001). Quality of life enhanced in the active group compared with the other groups, both at posttreatment (sham: -15.2 points; 95% CI, -26.6 to -3.9; P=.005; control: -13.7 points; 95% CI, 25.0 to -2.3; P=.012) and at follow-up (sham: -14.5 points; 95% CI, -25.2 to -3.7; P=.004; control: -17.4 points; 95% CI, -28.1 to -6.6; P<.001). Effect sizes for intergroup comparisons were medium across all outcomes: fatigue (η²=0.10; P=.01), sleep quality (η²=0.12; P<.01), and quality of life (η²=0.13; P<.01). No intergroup differences in any outcome were found between the sham and control groups. CONCLUSIONS: Combining UHCDS a-tDCS with TE can result in clinically significant improvements in fatigue, sleep disorders, and quality of life in people with FMS.