FibromyalgiaNCT07239427
Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.
A study testing Pain Science Education, Transcranial Direct Current Stimulation and Therapeutic Exercise in people with Fibromyalgia, run by University of Valladolid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Pain Science Education, Transcranial Direct Current Stimulation and Therapeutic Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a prior diagnosis of Fibromyalgia (FM), which must be documented and validated in the patient's medical record.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Unidad de Estrategias de Afrontamiento Activo del Dolor.
Valladolid, Valladolid, 47011
About this study
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
- Being tested
- Pain Science Education, Transcranial Direct Current Stimulation, Therapeutic Exercise, Sham Transcranial Direct Current Stimulation
- Keywords
- Fibromyalgia, Transcranial Direct Current Stimulation, Neuromodulation, Therapeutic Exercise, Pain Science Education, Pain Neuroscience Education
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Science EducationBehavioural
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 StimulationDevice
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 ExerciseBehavioural
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.
Sham Transcranial Direct Current StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Pain Science Education; Behavioral: Therapeutic Exercise; Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measures the current subjective pain level reported by the patient. Score of the Visual/Numeric Analog Scale (0 to 10).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Santos Bermejo, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239427
- Sponsor's protocol ID
- PI-25-574-APE
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Staud R, Weyl EE, Riley JL 3rd, Fillingim RB. Slow temporal summation of pain for assessment of central pain sensitivity and clinical pain of fibromyalgia patients. PLoS One. 2014 Feb 18;9(2):e89086. doi: 10.1371/journal.pone.0089086. eCollection 2014.
PubMed 24558475Staud R, Vierck CJ, Cannon RL, Mauderli AP, Price DD. Abnormal sensitization and temporal summation of second pain (wind-up) in patients with fibromyalgia syndrome. Pain. 2001 Mar;91(1-2):165-75. doi: 10.1016/s0304-3959(00)00432-2.
PubMed 11240089Sosa-Reina MD, Nunez-Nagy S, Gallego-Izquierdo T, Pecos-Martin D, Monserrat J, Alvarez-Mon M. Effectiveness of Therapeutic Exercise in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Biomed Res Int. 2017;2017:2356346. doi: 10.1155/2017/2356346. Epub 2017 Sep 20.
PubMed 29291206Serrat M, Almirall M, Muste M, Sanabria-Mazo JP, Feliu-Soler A, Mendez-Ulrich JL, Luciano JV, Sanz A. Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial. J Clin Med. 2020 Oct 18;9(10):3348. doi: 10.3390/jcm9103348.
PubMed 33081069Schmidt-Wilcke T, Luerding R, Weigand T, Jurgens T, Schuierer G, Leinisch E, Bogdahn U. Striatal grey matter increase in patients suffering from fibromyalgia--a voxel-based morphometry study. Pain. 2007 Nov;132 Suppl 1:S109-S116. doi: 10.1016/j.pain.2007.05.010. Epub 2007 Jun 22.
PubMed 17587497Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.
PubMed 33024295O'Brien AT, Deitos A, Trinanes Pego Y, Fregni F, Carrillo-de-la-Pena MT. Defective Endogenous Pain Modulation in Fibromyalgia: A Meta-Analysis of Temporal Summation and Conditioned Pain Modulation Paradigms. J Pain. 2018 Aug;19(8):819-836. doi: 10.1016/j.jpain.2018.01.010. Epub 2018 Feb 15.
PubMed 29454976Mhalla A, de Andrade DC, Baudic S, Perrot S, Bouhassira D. Alteration of cortical excitability in patients with fibromyalgia. Pain. 2010 Jun;149(3):495-500. doi: 10.1016/j.pain.2010.03.009. Epub 2010 Mar 31.
PubMed 20356675Mhalla A, Baudic S, de Andrade DC, Gautron M, Perrot S, Teixeira MJ, Attal N, Bouhassira D. Long-term maintenance of the analgesic effects of transcranial magnetic stimulation in fibromyalgia. Pain. 2011 Jul;152(7):1478-1485. doi: 10.1016/j.pain.2011.01.034. Epub 2011 Mar 11.
PubMed 21397400Mendonca ME, Simis M, Grecco LC, Battistella LR, Baptista AF, Fregni F. Transcranial Direct Current Stimulation Combined with Aerobic Exercise to Optimize Analgesic Responses in Fibromyalgia: A Randomized Placebo-Controlled Clinical Trial. Front Hum Neurosci. 2016 Mar 10;10:68. doi: 10.3389/fnhum.2016.00068. eCollection 2016.
PubMed 27014012Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.
PubMed 27377815Lutz J, Jager L, de Quervain D, Krauseneck T, Padberg F, Wichnalek M, Beyer A, Stahl R, Zirngibl B, Morhard D, Reiser M, Schelling G. White and gray matter abnormalities in the brain of patients with fibromyalgia: a diffusion-tensor and volumetric imaging study. Arthritis Rheum. 2008 Dec;58(12):3960-9. doi: 10.1002/art.24070.
PubMed 19035484Lloyd DM, Wittkopf PG, Arendsen LJ, Jones AKP. Is Transcranial Direct Current Stimulation (tDCS) Effective for the Treatment of Pain in Fibromyalgia? A Systematic Review and Meta-Analysis. J Pain. 2020 Nov-Dec;21(11-12):1085-1100. doi: 10.1016/j.jpain.2020.01.003. Epub 2020 Jan 23.
PubMed 31982685Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
PubMed 27866120Knijnik LM, Dussan-Sarria JA, Rozisky JR, Torres IL, Brunoni AR, Fregni F, Caumo W. Repetitive Transcranial Magnetic Stimulation for Fibromyalgia: Systematic Review and Meta-Analysis. Pain Pract. 2016 Mar;16(3):294-304. doi: 10.1111/papr.12276. Epub 2015 Jan 12.
PubMed 25581213
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT07239427
- Acronym / sponsor ID
- PI-25-574-APE
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Transcranial Direct Current Stimulation, Neuromodulation, Therapeutic Exercise, Pain Science Education, Pain Neuroscience Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS and Multimodal Active Pain Coping Program | Experimental | Behavioral: Pain Science Education, Device: Transcranial Direct Current Stimulation, Behavioral: Therapeutic ExerciseThis 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. |
| Sham tDCS and Multimodal Active Pain Coping Program | Sham comparator | Behavioral: Pain Science Education, Behavioral: Therapeutic Exercise, Device: Sham Transcranial Direct Current StimulationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must have a prior diagnosis of Fibromyalgia (FM), which must be documented and validated in the patient's medical record.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Science EducationPain 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. | Behavioural | Active tDCS and Multimodal Active Pain Coping Program, Sham tDCS and Multimodal Active Pain Coping Program |
| Transcranial Direct Current StimulationTranscranial 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. | Device | Active tDCS and Multimodal Active Pain Coping Program |
| Therapeutic ExerciseTherapeutic 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. | Behavioural | Active tDCS and Multimodal Active Pain Coping Program, Sham tDCS and Multimodal Active Pain Coping Program |
| Sham Transcranial Direct Current StimulationControl 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. | Device | Sham tDCS and Multimodal Active Pain Coping Program |
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ)
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.
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.
9 secondary outcomes
Pain Intensity (Visual analogue scale)
Time frame: Baseline, Post-Intervention (12 weeks), and Follow-up (6 months).
Conditioned Pain Modulation (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)
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
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)
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)
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)
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)
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)
Time frame: Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 24558475Staud R, Weyl EE, Riley JL 3rd, Fillingim RB. Slow temporal summation of pain for assessment of central pain sensitivity and clinical pain of fibromyalgia patients. PLoS One. 2014 Feb 18;9(2):e89086. doi: 10.1371/journal.pone.0089086. eCollection 2014.
- Results publication: PubMed 11240089Staud R, Vierck CJ, Cannon RL, Mauderli AP, Price DD. Abnormal sensitization and temporal summation of second pain (wind-up) in patients with fibromyalgia syndrome. Pain. 2001 Mar;91(1-2):165-75. doi: 10.1016/s0304-3959(00)00432-2.
- Results publication: PubMed 29291206Sosa-Reina MD, Nunez-Nagy S, Gallego-Izquierdo T, Pecos-Martin D, Monserrat J, Alvarez-Mon M. Effectiveness of Therapeutic Exercise in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Biomed Res Int. 2017;2017:2356346. doi: 10.1155/2017/2356346. Epub 2017 Sep 20.
- Results publication: PubMed 33081069Serrat M, Almirall M, Muste M, Sanabria-Mazo JP, Feliu-Soler A, Mendez-Ulrich JL, Luciano JV, Sanz A. Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial. J Clin Med. 2020 Oct 18;9(10):3348. doi: 10.3390/jcm9103348.
- Results publication: PubMed 17587497Schmidt-Wilcke T, Luerding R, Weigand T, Jurgens T, Schuierer G, Leinisch E, Bogdahn U. Striatal grey matter increase in patients suffering from fibromyalgia--a voxel-based morphometry study. Pain. 2007 Nov;132 Suppl 1:S109-S116. doi: 10.1016/j.pain.2007.05.010. Epub 2007 Jun 22.
- Results publication: PubMed 33024295Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.
- Results publication: PubMed 29454976O'Brien AT, Deitos A, Trinanes Pego Y, Fregni F, Carrillo-de-la-Pena MT. Defective Endogenous Pain Modulation in Fibromyalgia: A Meta-Analysis of Temporal Summation and Conditioned Pain Modulation Paradigms. J Pain. 2018 Aug;19(8):819-836. doi: 10.1016/j.jpain.2018.01.010. Epub 2018 Feb 15.
- Results publication: PubMed 20356675Mhalla A, de Andrade DC, Baudic S, Perrot S, Bouhassira D. Alteration of cortical excitability in patients with fibromyalgia. Pain. 2010 Jun;149(3):495-500. doi: 10.1016/j.pain.2010.03.009. Epub 2010 Mar 31.
- Results publication: PubMed 21397400Mhalla A, Baudic S, de Andrade DC, Gautron M, Perrot S, Teixeira MJ, Attal N, Bouhassira D. Long-term maintenance of the analgesic effects of transcranial magnetic stimulation in fibromyalgia. Pain. 2011 Jul;152(7):1478-1485. doi: 10.1016/j.pain.2011.01.034. Epub 2011 Mar 11.
- Results publication: PubMed 27014012Mendonca ME, Simis M, Grecco LC, Battistella LR, Baptista AF, Fregni F. Transcranial Direct Current Stimulation Combined with Aerobic Exercise to Optimize Analgesic Responses in Fibromyalgia: A Randomized Placebo-Controlled Clinical Trial. Front Hum Neurosci. 2016 Mar 10;10:68. doi: 10.3389/fnhum.2016.00068. eCollection 2016.
- Results publication: PubMed 27377815Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.
- Results publication: PubMed 19035484Lutz J, Jager L, de Quervain D, Krauseneck T, Padberg F, Wichnalek M, Beyer A, Stahl R, Zirngibl B, Morhard D, Reiser M, Schelling G. White and gray matter abnormalities in the brain of patients with fibromyalgia: a diffusion-tensor and volumetric imaging study. Arthritis Rheum. 2008 Dec;58(12):3960-9. doi: 10.1002/art.24070.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Science Education, Transcranial Direct Current Stimulation and Therapeutic Exercise in people with Fibromyalgia, run by University of Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Montero Cuadrado, Physiotherapy (+34 651529993, fmonteroc@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (FIQ) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07239427, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.