Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.

Overview

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

• Behavioral Pain 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 m
• Device Transcranial 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 curr
• Behavioral Therapeutic 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
• Device Sham 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.

Primary outcome measures

• 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.]

Secondary outcome measures (9)

• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Unidad de Estrategias de Afrontamiento Activo del Dolor. — Valladolid

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. PMID 24558475
• Staud 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. PMID 11240089
• Sosa-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. PMID 29291206
• Serrat 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. PMID 33081069
• Schmidt-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. PMID 17587497
• Sarzi-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. PMID 33024295
• O'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. PMID 29454976
• Mhalla 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. PMID 20356675

Identifiers

NCT: NCT07239427 · PI-25-574-APE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗