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

University of Valladolid (UVA)

Status: Enrolling

Conditions: Fibromyalgia

Treatments: Behavioral: Therapeutic Exercise; Behavioral: Pain Science Education; Device: Transcranial Direct Current Stimulation; Device: Sham Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07239427

PI-25-574-APE

Details and patient eligibility

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups

Active tDCS and Multimodal Active Pain Coping Program

Experimental group

Description:

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Behavioral: Therapeutic Exercise

Behavioral: Pain Science Education

Sham tDCS and Multimodal Active Pain Coping Program

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Transcranial Direct Current Stimulation

Behavioral: Therapeutic Exercise

Behavioral: Pain Science Education