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TDCS and Tele-rehabilitation Exercise in Fibromyalgia
Sponsor: University of Valladolid
Summary
This randomized controlled trial aims to analyze the effects of anodal tDCS applied over the primary motor cortex and dorsolateral prefrontal cortex combined with a tele-rehabilitation exercise program in patients with fibromyalgia. The study will compare these effects with each other and with placebo tDCS on the following variables: pain intensity, pain mechanosensitivity, quality of life, fatigue, anxiety, depression, sleep quality, pain catastrophizing, functional capacity, isometric strength, and exercise adherence. Secondary objectives include: * Describing the sociodemographic, clinical, and functional characteristics of fibromyalgia patients. * Comparing exercise intensity levels between patients receiving tDCS on M1, DLPFC, and placebo stimulation. * Reporting any adverse effects of the intervention. Adult participants with fibromyalgia will be randomized into three groups: a) anodal tDCS over M1 + telerehabilitation, b) anodal tDCS over DLPFC + telerehabilitation, and c) sham-tDCS + telerehabilitation. The intervention will last for 12 weeks. The telerehabilitation exercise program will include an aerobic phase and a resistance phase, with four intensity levels regulated based on the Borg Rating of Perceived Exertion (0-10). The program will be conducted remotely through phone contact, with materials and videos provided to guide exercise execution. tDCS will be applied once per week for 20 minutes at 2 mA, either over M1 or DLPFC. The dependent variables-pain intensity, fibromyalgia impact, fatigue, anxiety and depression levels, pain catastrophizing, sleep quality, functional capacity, and isometric muscle strength-will be collected in the week prior to the intervention, the week following the intervention, and 12 weeks after its completion. Additionally, pain intensity, fibromyalgia impact, fatigue severity, anxiety and depression levels, pain catastrophizing, and sleep quality will be evaluated during the 6th week of the intervention. Exercise intensity, exercise adherence, and any adverse effects related to the intervention will be recorded weekly.
Official title: Effects of Anodal TDCS Applied Over M1 and DLPFC Combined with a Telerehabilitation Exercise Program in Patients with Fibromyalgia: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
30 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2024-12-01
Completion Date
2026-12-01
Last Updated
2024-09-27
Healthy Volunteers
No
Conditions
Interventions
Anodal tDCS over M1
The anode will be placed over the left M1 (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.
Anodal tDCS over DLPFC
The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC) (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.
Exercise telerehabilitation
Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance training will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored through video and weekly phone contact.