Fibromyalgia
Conditions
Keywords
Fibromyalgia, Transcranial Direct Current Stimulation, Neuromodulation, Therapeutic Exercise, Pain Science Education, Pain Neuroscience Education
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.
Interventions
BEHAVIORALPain Science Education
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.
DEVICETranscranial Direct Current Stimulation
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.
BEHAVIORALTherapeutic Exercise
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.
DEVICESham Transcranial Direct Current Stimulation
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.
Sponsors
University of Valladolid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibromyalgia Impact Questionnaire (FIQ) | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conditioned Pain Modulation (CPM) | Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment. | 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) | Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment. | 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 | Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment. | 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). |
| Pain Catastrophizing Scale (PCS) | Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment. | 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. |
| Pain Intensity (Visual analogue scale) | Baseline, Post-Intervention (12 weeks), and Follow-up (6 months). | Measures the current subjective pain level reported by the patient. Score of the Visual/Numeric Analog Scale (0 to 10). |
| Tampa Scale Kinesiophobia (TSK-11) | Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment. | 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. |
| Medical Outcomes Study Sleep Scale (MOS SS) | Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment. | 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 |
| International Physical Activity Questionnaire (IPAQ) | Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment. | 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 |
| Hospital Anxiety and Depression Scale (HADS) | Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment. | 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. |
Countries
Spain
Contacts
Primary ContactFederico Montero Cuadrado, Physiotherapy
Outcome results
None listed