Not Yet RecruitingNot Applicable

TDCS and Tele-rehabilitation Exercise in Fibromyalgia

45 participantsStarted 2024-12-01

Plain-language 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.

Who can participate

Age range

30 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 30 and 70 years. * Medical diagnosis of fibromyalgia.Compliance with the latest diagnostic criteria from the American College of Rheumatology. * Stable medication for at least 12 weeks prior to the start of the study. * Ability to use communication technologies, such as smartphones and computers. * Capacity to participate in an aerobic exercise program. * Access to the internet. * Proficiency in oral and written Spanish. * Signed informed consent Exclusion Criteria: * Severe psychiatric disorders. * Uncontrolled cardiovascular, respiratory, metabolic, neurological, rheumatic, or hepatic diseases. * Concurrent chronic inflammatory or autoimmune disease. * Contraindications to physical activity. * Metal implants in the head. * History of cancer, brain tumor, epileptic episodes, stroke, severe head trauma, or brain surgery. * Pregnancy or lactation. * Use of carbamazepine in the past 6 months. * Changes in medication during the study. * Participation in other non-pharmacological conservative therapies (e.g., hydrotherapy, electrotherapy, manual therapy, exercise, dry needling) during the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain intensity

Timeframe: At pre-intervention, at weeks 12 and 24.

Trial details

NCT IDNCT06616181

SponsorUniversity of Valladolid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

Contact for this trial

Ignacio Hernando Garijo

975129145 ignacio.hernando@uva.es

View on ClinicalTrials.gov More Fibromyalgia Syndrome trials