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.
Must have a prior diagnosis of Fibromyalgia (FM), which must be documented and validated in the patient's medical record.
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.
Parallel
Pain Science Education
BehavioralPain 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
DeviceTranscranial 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
BehavioralTherapeutic 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.
Sham Transcranial Direct Current Stimulation
DeviceControl 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.
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.
Pain Intensity (Visual analogue scale)
Measures the current subjective pain level reported by the patient. Score of the Visual/Numeric Analog Scale (0 to 10).
Conditioned Pain Modulation (CPM)
The Conditioned Pain Modulation (CPM) test is used to assess the central nervous system's capacity for endogenous pain inhibition. Using a parallel paradigm, a Test Stimulus (T-Test), which measures the baseline Pressure Pain Threshold (PPT), is measured simultaneously with a Conditioning Stimulus (C-Test). The C-Test is applied by inflating a blood pressure cuff to induce ischemia in the contralateral limb. The pain threshold is then measured again at the T-Test site while the ischemic stimulus is active. The CPM effect is quantified as the change (either the absolute difference or percentage change) in the PPT measured during the ischemic stimulation compared to the baseline PPT, where an increase in the threshold indicates effective CPM.
Pressure Pain Thresholds (PPT)
Pressure Pain Thresholds (PPTs) are measured using a Wagner brand Fisher digital algometer to quantify local pain sensitivity in $\\text{kg/cm}\^2$. Measurements are taken at four specific anatomical reference points bilaterally: the midpoint between the posterior border of the acromion and the C7 spinal process, and the midpoint between the highest part of the superior border of the iliac crest and the spinal process at the same height. At each point, two consecutive measurements are taken by increasing pressure at a rate of $1\\text{ kg/cm}\^2$ per second. The threshold is determined when the participant reports that the sensation of pressure turns into pain. The final PPT score for each site is the average of the two consecutive measurements. A lower PPT indicates increased local pain sensitivity.
Change in Temporal Summation
Temporal Summation (TS) is used to assess central sensitization (the wind-up phenomenon). It is provoked by applying 10 consecutive pulses using a pressure algometer at the previously determined Pressure Pain Threshold (PPT) for the specific location. For each pulse, pressure is gradually increased at a rate of 2kg/s to reach the PPT, held for 1 second, and then released with a 1-second interval before the next pulse. The participant rates the pain intensity of the first, fifth, and tenth pulse on a Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain). A score increase between the first and tenth pulse indicates efficient temporal summation (central sensitization).
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