Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.
University of Valladolid
68 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- Must have a prior diagnosis of Fibromyalgia (FM), which must be documented and validated in the patient's medical record.
Exclusion Criteria6
- 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.
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Interventions
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.
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.
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.
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.
Locations(1)
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NCT07239427