Rafael Velasco-Velasco, Juan Avendaño-Coy, Elena Labrador-García, Elisabeth Bravo-Esteban, Rubén Arroyo-Fernández
{"title":"双点经颅直流电刺激联合运动可改善纤维肌痛患者的疲劳和睡眠质量：一项随机假对照临床试验","authors":"Rafael Velasco-Velasco, Juan Avendaño-Coy, Elena Labrador-García, Elisabeth Bravo-Esteban, Rubén Arroyo-Fernández","doi":"10.1016/j.apmr.2025.07.022","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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).</p><p><strong>Design: </strong>Double-blind, randomized, sham-controlled trial.</p><p><strong>Setting: </strong>Primary health care center.</p><p><strong>Participants: </strong>A total of 90 volunteers diagnosed with fibromyalgia. Nine participants dropped out of the study.</p><p><strong>Intervention: </strong>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.</p><p><strong>Outcome measures: </strong>Fatigue, sleep quality, and quality of life.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>Combining UHCDS a-tDCS with TE can result in clinically significant improvements in fatigue, sleep disorders, and quality of life in people with FMS.</p>","PeriodicalId":8313,"journal":{"name":"Archives of physical medicine and rehabilitation","volume":" ","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2025-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Dual-Site Transcranial Direct Current Stimulation Combined With Exercising Improves Fatigue and Sleep Quality in People With Fibromyalgia: A Randomized Sham-Controlled Clinical Trial.\",\"authors\":\"Rafael Velasco-Velasco, Juan Avendaño-Coy, Elena Labrador-García, Elisabeth Bravo-Esteban, Rubén Arroyo-Fernández\",\"doi\":\"10.1016/j.apmr.2025.07.022\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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).</p><p><strong>Design: </strong>Double-blind, randomized, sham-controlled trial.</p><p><strong>Setting: </strong>Primary health care center.</p><p><strong>Participants: </strong>A total of 90 volunteers diagnosed with fibromyalgia. Nine participants dropped out of the study.</p><p><strong>Intervention: </strong>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.</p><p><strong>Outcome measures: </strong>Fatigue, sleep quality, and quality of life.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>Combining UHCDS a-tDCS with TE can result in clinically significant improvements in fatigue, sleep disorders, and quality of life in people with FMS.</p>\",\"PeriodicalId\":8313,\"journal\":{\"name\":\"Archives of physical medicine and rehabilitation\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2025-08-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Archives of physical medicine and rehabilitation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.apmr.2025.07.022\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"REHABILITATION\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of physical medicine and rehabilitation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.apmr.2025.07.022","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"REHABILITATION","Score":null,"Total":0}
引用次数: 0
摘要
目的：评价UHCDS - tdcs +治疗性运动（TE）联合方案对FMS患者疲劳和睡眠质量的影响。设计：双盲、随机、假对照试验。环境：初级卫生保健中心。参与者：90名被诊断为纤维肌痛的志愿者。9名参与者退出了研究。干预：参与者按1:1:1的比例随机分配到活动UHCDS a- tdcs +TE、假UHCDS a- tdcs +TE或对照组接受TE。干预在6周内分10次进行。结局指标：疲劳、睡眠质量和生活质量。结果：与假手术组相比，运动组的疲劳评分明显降低(-9.8分；95% CI -18.9 ~ -0.8；P =0.028)和对照组(-9.9分；95% CI -18.9 ~ -0.9；P =0.027)，随访时与对照组比较(-11.5分；95% CI -20.8 ~ -2.1；p = 0.01)。治疗后，与假手术组和对照组相比，活跃组的睡眠质量有所改善(假手术：-14.4点，95% CI -24.2至-4.5；p = 0.002;对照组：-19.5点，95% CI -29.4至-9.7；结论：UHCDS a-tDCS联合TE可显著改善FMS患者的疲劳、睡眠障碍和生活质量。临床试验注册号：NCT05726149 （clinclintrials .gov）。
Dual-Site Transcranial Direct Current Stimulation Combined With Exercising Improves Fatigue and Sleep Quality in People With Fibromyalgia: A Randomized Sham-Controlled Clinical Trial.
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).
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.
期刊介绍：
The Archives of Physical Medicine and Rehabilitation publishes original, peer-reviewed research and clinical reports on important trends and developments in physical medicine and rehabilitation and related fields. This international journal brings researchers and clinicians authoritative information on the therapeutic utilization of physical, behavioral and pharmaceutical agents in providing comprehensive care for individuals with chronic illness and disabilities.
Archives began publication in 1920, publishes monthly, and is the official journal of the American Congress of Rehabilitation Medicine. Its papers are cited more often than any other rehabilitation journal.
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