Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a prior diagnosis of Fibromyalgia (FM), which must be documented and validated in the patient's medical record.
排除标准
- •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.
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: 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.
次要结局
- Pain Intensity (Visual analogue scale)(Baseline, Post-Intervention (12 weeks), and Follow-up (6 months).)
- Pressure Pain Thresholds (PPT)(Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.)
- Conditioned Pain Modulation (CPM)(Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.)
- Change in Temporal Summation(Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.)
- Pain Catastrophizing Scale (PCS)(Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.)
- Tampa Scale Kinesiophobia (TSK-11)(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)(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)(Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.)
- International Physical Activity Questionnaire (IPAQ)(Baseline, post-intervention (end of the 12-week treatment protocol), and at a 3-month follow-up after treatment.)
研究者
Manuel Santos Bermejo
MSc
University of Valladolid