Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Must have a prior diagnosis of Fibromyalgia (FM), which must be documented and validated in the patient's medical record.

Locations
Other Locations
Spain
Unidad de Estrategias de Afrontamiento Activo del Dolor.
RECRUITING
Valladolid
Contact Information
Primary
Federico Montero Cuadrado, Physiotherapy
fmonteroc@saludcastillayleon.es
+34 651529993
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 68
Treatments
Experimental: Active tDCS and Multimodal Active Pain Coping Program
This group receives the Multimodal Active Pain Coping Program. The intervention sequence is: 8 sessions of Pain Neuroscience Education (PNE), followed by 5 daily sessions of Active Transcranial Direct Current Stimulation (tDCS), and then 18 sessions of Therapeutic Exercise (TE). The Active tDCS is applied over the primary motor cortex (M1) and orbitofrontal region for 20 minutes at 2 mA, aiming to potentiate the analgesic effects of the overall Active Pain Coping strategies.
Sham_comparator: Sham tDCS and Multimodal Active Pain Coping Program
This group receives the identical Multimodal Active Pain Coping Program. The intervention sequence is: 8 sessions of Pain Neuroscience Education (PNE), followed by 5 daily sessions of Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), and then 18 sessions of Therapeutic Exercise (TE). The Sham tDCS uses the same electrode placement but only runs for a few seconds to maintain participant blinding, providing no active current for the remainder of the 20-minute session.
Related Therapeutic Areas
Sponsors
Leads: University of Valladolid

This content was sourced from clinicaltrials.gov