NCT07239427 Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.
| NCT ID | NCT07239427 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Valladolid |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2025-12-01 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The trial is designed to determine the added effect of active transcranial direct current stimulation (tDCS) when combined with a multimodal Active Pain Coping Program in individuals with fibromyalgia. The primary objective is to compare the effectiveness of active versus sham tDCS when both are delivered to the same standardized multimodal intervention. All participants will undergo an identical treatment sequence consisting of 8 sessions of Pain Neuroscience Education (PNE), followed by 5 consecutive daily sessions of either active or sham tDCS, and 18 sessions of therapeutic exercise (TE). Active tDCS will be administered over the primary motor cortex (M1) and orbitofrontal region for 20 minutes at 2 mA. The sham procedure will replicate the electrode placement and brief initial stimulation to ensure blinding, with no active current thereafter. Secondary outcomes will examine changes in pain intensity, central pain processing, psychological variables, and physical function.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07239427 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07239427 currently recruiting?
Yes, NCT07239427 is actively recruiting participants. Contact the research team at fmonteroc@saludcastillayleon.es for enrollment information.
Where is the NCT07239427 trial being conducted?
This trial is being conducted at Valladolid, Spain.
Who is sponsoring the NCT07239427 clinical trial?
NCT07239427 is sponsored by University of Valladolid. The trial plans to enroll 68 participants.
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