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

NCT07239427 | Recruiting

• 1 other identifier: PI-25-574-APE
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Transcranial Direct Current Stimulation; Neuromodulation; Therapeutic Exercise; Pain Science Education; Pain Neuroscience Education

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia Impact Questionnaire (FIQ)

  The Fibromyalgia Impact Questionnaire (FIQ) assesses the global impact and severity of FM across 10 items covering Physical Function, Work Status, and Symptoms (pain, fatigue, stiffness, etc.). The total score ranges from 0 to 100. The calculation involves summing and scaling the scores from the three components: Physical Function is scored on a 4-point scale (0-3) and the sum is then multiplied by 3; Work Status and Symptoms (rated on VAS/NRS) are scaled to contribute to the final 100-point total. The FIQ is a disability and severity index: a higher score (closer to 100) indicates a greater impact of fibromyalgia, signifying higher functional disability, more severe symptoms, and a worse quality of life. Conversely, a lower score (closer to 0) indicates a better health status. The primary objective is to observe a significant decrease in this score.

  Outcome measures will be assessed at baseline (enrollment), post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.

Secondary Outcomes (9)

• Pain Intensity (Visual analogue scale)

  Baseline, Post-Intervention (12 weeks), and Follow-up (6 months).

• Conditioned Pain Modulation (CPM)

  Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.

• Pressure Pain Thresholds (PPT)

  Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.

• Change in Temporal Summation

  Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.

• Pain Catastrophizing Scale (PCS)

  Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.

Study Arms (2)

Active tDCS and Multimodal Active Pain Coping Program

EXPERIMENTAL

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.

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

Sham tDCS and Multimodal Active Pain Coping Program

SHAM COMPARATOR

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.

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

Interventions

Pain Science Education BEHAVIORAL

Pain Science Education component is the initial phase of the multimodal Active Pain Coping program. Its objective is to reframe maladaptive beliefs about pain in Fibromyalgia patients by providing a modern neuroscientific understanding of their persistent pain condition. The content focuses on explaining that pain does not necessarily equate to tissue damage but is a protective output generated by the brain, addressing the physiology of pain and sensitization, the relationship between fear and movement avoidance (kinesiophobia), and the potential of neuroplasticity to "retrain" the nervous system. This phase is crucial for reducing pain catastrophizing and fear, thereby empowering the patient to actively and fully participate in the subsequent treatment phases.

Active tDCS and Multimodal Active Pain Coping Program; Sham tDCS and Multimodal Active Pain Coping Program

Transcranial Direct Current Stimulation DEVICE

Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique used in this study to enhance the central analgesic effects of the combined Active Pain Coping treatment. The intervention involves the delivery of a low-intensity electrical current through the scalp to modulate cortical excitability. The Anode is positioned over the Primary Motor Cortex (M1) (C3) and the Cathode is placed over the Orbitofrontal region (FP2). The Active Group receives a constant 2 mA current for 20 minutes to modulate brain activity.

Active tDCS and Multimodal Active Pain Coping Program

Therapeutic Exercise BEHAVIORAL

Therapeutic Exercise (TE) is the most extensive component of the multimodal program, administered in structured group sessions lasting approximately one hour. The protocol is designed to be adapted to each patient's physical condition, and includes a graded exposure component to ensure safety and mitigate pain flares. Each session includes a warm-up (mobility/activation); a main phase focused on conscious movement, coordination, balance, agility, and muscular strength; and a final cool-down that incorporates flexibility, relaxation, and mindfulness. The primary purpose of this structured exercise is to safely promote physical activity, reverse physical deconditioning and muscle atrophy, reduce fear of movement (kinesiophobia), and reinforce the new neuroscientific understanding of pain acquired, thereby sustaining the overall analgesic effects of the treatment.

Active tDCS and Multimodal Active Pain Coping Program; Sham tDCS and Multimodal Active Pain Coping Program

Sham Transcranial Direct Current Stimulation DEVICE

Control Group receives an identical-looking Sham (Placebo) stimulation, where the device runs for only the initial minute (at 2 mA) before turning off silently, ensuring the participants remain blinded to the treatment they receive.

Sham tDCS and Multimodal Active Pain Coping Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valladolid: lead

Study Sites (1)

Unidad de Estrategias de Afrontamiento Activo del Dolor.

Valladolid, Valladolid, 47011, Spain

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Fibromyalgia

Interventions

Transcranial Direct Current Stimulation; Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities

Central Study Contacts

Federico Montero Cuadrado, Physiotherapy

CONTACT

+34 651529993; fmonteroc@saludcastillayleon.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are masked (blinded): Participants are unaware of their group assignment, as the control group receives a sham Transcranial Direct Current Stimulation (tDCS) protocol that is designed to be indistinguishable from the active stimulation. Investigators are masked (blinded): The study personnel responsible for collecting the primary outcome data and performing the statistical analysis will also be masked (blinded) to the participants' group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)