An interventional study of Pain Science Education and Transcranial Direct Current Stimulation in Fibromyalgia, sponsored by University of Valladolid. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by University of Valladolid · Not applicable, Interventional, and Treatment
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 68 is above the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →University of Valladolid is the lead sponsor of 34 studies on the registry; 9 are open to participants now.
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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
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
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.
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.
Time frame: 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.
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).
Time frame: Baseline, Post-Intervention (12 weeks), and Follow-up (6 months).
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.
Time frame: Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.
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.
Time frame: Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.
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).
Time frame: Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a 13-item psychometric tool used to assess negative cognitive and emotional responses related to actual or anticipated pain. The scale evaluates three subcomponents: Rumination (inability to stop focusing on pain), Magnification (exaggerating the threat of pain), and Helplessness (feeling unable to cope with the pain). Each of the 13 items is rated on a 5-point Likert scale, ranging from 0 ("not at all") to 4 ("all the time"). The total score is calculated by summing the scores from all 13 items, resulting in a final score that ranges from 0 to 52. A higher score on the PCS indicates greater pain catastrophizing (a worse cognitive outcome), which is strongly associated with increased pain intensity and functional disability.
Time frame: Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item screening tool used to assess the severity of Anxiety and Depression symptoms in medical patients, avoiding confounding physical symptoms. It comprises two subscales: HADS-A (Anxiety) and HADS-D (Depression), each containing 7 intermingled items. Each item is rated on a 4-point Likert scale ranging from 0 ("not at all") to 3 ("most of the time"). The total score for each separate subscale ranges from 0 to 21. A higher score on either the HADS-A or HADS-D subscale indicates greater severity of anxiety or depressive symptoms, respectively. Scores are used both as continuous variables and often categorized for clinical interpretation.
Time frame: Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.
Tampa Scale Kinesiophobia (TSK-11)
The Tampa Scale for Kinesiophobia (TSK-11) is an 11-item tool used to assess fear of movement, injury, or re-injury (kinesiophobia). It specifically evaluates the patient's belief that physical activity is dangerous or harmful. Each of the 11 items is scored on a 4-point Likert scale, ranging from 1 ("strongly disagree") to 4 ("strongly agree"). The total score is calculated by summing the scores from all 11 items, with some items being reverse-scored to maintain consistency. The final score ranges from 11 to 44. A higher total score on the TSK-11 indicates greater kinesiophobia and subsequent avoidance behaviors, which are linked to increased pain intensity and functional disability in chronic pain populations.
Time frame: Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.
Medical Outcomes Study Sleep Scale (MOS SS)
12-item questionnaire that assesses a person's sleep quality and problems over a four-week period. It measures six key areas: sleep disturbance, sleep adequacy, somnolence (daytime sleepiness), snoring, waking due to shortness of breath or headache, and quantity of sleep. The scale yields scores for these six domains, as well as two global sleep problem indices
Time frame: Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.
International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire (IPAQ) is a standardized tool that defines and measures physical activity based on frequency and duration over a week. It categorizes physical activity into vigorous-intensity, moderate-intensity, and walking, and also assesses time spent sitting. The IPAQ covers activity across different domains, including work, transportation, domestic chores, and leisure time, to provide a comprehensive picture of a person's physical activit
Time frame: Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.
Plan to share: No
Start is estimated for Dec 2025; primary completion for Mar 2026, 3 months later.
Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 3 months is below that.
Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.
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