Adding mild brain stimulation to a pain-coping program for people with fibromyalgia
Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.
This project will test whether adding mild transcranial direct current stimulation to a pain education and exercise program helps people with fibromyalgia have less pain and better function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Valladolid Academic / other |
| Locations | 1 site (Valladolid, Valladolid) |
| Trial ID | NCT07239427 on ClinicalTrials.gov |
What this trial studies
Adults with documented fibromyalgia are randomized to receive either active or sham transcranial direct current stimulation (tDCS) alongside an identical multimodal Active Pain Coping Program. All participants complete eight sessions of Pain Neuroscience Education, five consecutive daily sessions of active or sham tDCS, and 18 sessions of therapeutic exercise. Active tDCS is applied at 2 mA for 20 minutes over the primary motor cortex and orbitofrontal region, while the sham condition reproduces electrode placement and a brief initial sensation to maintain blinding. Outcomes compared between groups include pain intensity, measures of central pain processing, psychological variables, and physical function.
Who should consider this trial
Good fit: Adults with a documented medical diagnosis of fibromyalgia who can attend in-person sessions and have no contraindications to tDCS (for example, no epilepsy, skull metallic implants, or pregnancy) are the intended participants.
Not a fit: People with contraindicating neurological conditions, active serious medical issues, metallic skull implants, pregnancy, or an inability to follow the protocol are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, adding tDCS could enhance pain reduction and improve function and coping when paired with structured education and exercise.
How similar studies have performed: Previous tDCS trials in fibromyalgia have shown mixed but sometimes positive pain-relief results, while combining tDCS with structured pain education and exercise is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must have a prior diagnosis of Fibromyalgia (FM), which must be documented and validated in the patient's medical record. Exclusion Criteria: * Neurological Conditions: History of epilepsy or any other decompensated neurological condition that could contraindicate Transcranial Direct Current Stimulation (tDCS). * Active Pathologies: Presence of other active or recent pathologies (e.g., cancer, fractures, fissures, or severe traumatic accidents of the skull) that could interfere with treatment or evaluation. * Pregnancy: Currently pregnant or planning to become pregnant during the study period. * Metallic Implants: Presence of metallic implants in the skull that may interact with or contraindicate the use of tDCS. * Concurrent Studies: Active participation in another concurrent clinical research study involving treatments for fibromyalgia. * Protocol Adherence: Inability to understand or adhere to the treatment and evaluation protocol.
Where this trial is running
Valladolid, Valladolid
- Unidad de Estrategias de Afrontamiento Activo del Dolor. — Valladolid, Valladolid, Spain (Recruiting)
Study contacts
- Study coordinator: Federico Montero Cuadrado, Physiotherapy
- Email: fmonteroc@saludcastillayleon.es
- Phone: +34 651529993
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.