Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.
Recruiting · NCT07239427 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Valladolid
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Unidad de Estrategias de Afrontamiento Activo del Dolor. - Valladolid, Valladolid, Spain