TDCS and Tele-rehabilitation Exercise in Fibromyalgia

Официальное название

Effects of Anodal TDCS Applied Over M1 and DLPFC Combined with a Telerehabilitation Exercise Program in Patients with Fibromyalgia: a Randomized Controlled Trial

Обзор

This randomized controlled trial aims to analyze the effects of anodal tDCS applied over the primary motor cortex and dorsolateral prefrontal cortex combined with a tele-rehabilitation exercise program in patients with fibromyalgia. The study will compare these effects with each other and with placebo tDCS on the following variables: pain intensity, pain mechanosensitivity, quality of life, fatigue, anxiety, depression, sleep quality, pain catastrophizing, functional capacity, isometric strength, and exercise adherence. Secondary objectives include: * Describing the sociodemographic, clinical, and functional characteristics of fibromyalgia patients. * Comparing exercise intensity levels between patients receiving tDCS on M1, DLPFC, and placebo stimulation. * Reporting any adverse effects of the intervention. Adult participants with fibromyalgia will be randomized into three groups: a) anodal tDCS over M1 + telerehabilitation, b) anodal tDCS over DLPFC + telerehabilitation, and c) sham-tDCS + telerehabilitation. The intervention will last for 12 weeks. The telerehabilitation exercise program will include an aerobic phase and a resistance phase, with four intensity levels regulated based on the Borg Rating of Perceived Exertion (0-10). The program will be conducted remotely through phone contact, with materials and videos provided to guide exercise execution. tDCS will be applied once per week for 20 minutes at 2 mA, either over M1 or DLPFC. The dependent variables-pain intensity, fibromyalgia impact, fatigue, anxiety and depression levels, pain catastrophizing, sleep quality, functional capacity, and isometric muscle strength-will be collected in the week prior to the intervention, the week following the intervention, and 12 weeks after its completion. Additionally, pain intensity, fibromyalgia impact, fatigue severity, anxiety and depression levels, pain catastrophizing, and sleep quality will be evaluated during the 6th week of the intervention. Exercise intensity, exercise adherence, and any adverse effects related to the intervention will be recorded weekly.

Вмешательства

• Устройство Anodal tDCS over M1
  The anode will be placed over the left M1 (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.
• Устройство Anodal tDCS over DLPFC
  The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC) (C3 according to the International 10-20 system), and the cathode will be positioned over the right supraorbital area (FP2). Once the electrodes are positioned, continuous stimulation at 2mA will be applied for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.
• Поведенческое Exercise telerehabilitation
  Two weekly 50-minute sessions of mixed exercise, including both aerobic and resistance components, will be performed. Aerobic exercises will involve large muscle groups, and resistance training will be performed through elastic bands of varying intensity will be used for strengthening exercises. Exercise intensity will be regulated using the modified Borg Rating of Perceived Exertion scale (0-10), with participants maintaining between 4 and 7 points on this scale. The exercises will be monitored

Первичные конечные точки

• Pain intensity [Срок оценки: At pre-intervention, at weeks 12 and 24.]

Вторичные конечные точки (9)

• Pain mechanosensitivity [Срок оценки: At pre-intervention, at weeks 12 and 24.]
• Fatigue [Срок оценки: At pre-intervention, at weeks 12 and 24.]
• Sleep Quality [Срок оценки: At pre-intervention, at weeks 12 and 24.]
• Pain Catastrophizing [Срок оценки: At pre-intervention, at weeks 12 and 24.]
• Isometric Strength [Срок оценки: At pre-intervention, at weeks 12 and 24.]
• Exercise Adherence [Срок оценки: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12.]
• 6-Minute Walk Test [Срок оценки: At pre-intervention, at 12 and 24 weeks.]
• 30-second Chair Stand Test [Срок оценки: At pre-intervention, at weeks 12 and 24.]
• Fibromyalgia Impact [Срок оценки: At pre-intervention, at weeks 12 and 24.]

Критерии участия

Критерии включения

• Age between 30 and 70 years.
• Medical diagnosis of fibromyalgia.Compliance with the latest diagnostic criteria from the American College of Rheumatology.
• Stable medication for at least 12 weeks prior to the start of the study.
• Ability to use communication technologies, such as smartphones and computers.
• Capacity to participate in an aerobic exercise program.
• Access to the internet.
• Proficiency in oral and written Spanish.
• Signed informed consent

Критерии исключения

• Severe psychiatric disorders.
• Uncontrolled cardiovascular, respiratory, metabolic, neurological, rheumatic, or hepatic diseases.
• Concurrent chronic inflammatory or autoimmune disease.
• Contraindications to physical activity.
• Metal implants in the head.
• History of cancer, brain tumor, epileptic episodes, stroke, severe head trauma, or brain surgery.
• Pregnancy or lactation.
• Use of carbamazepine in the past 6 months.
• Changes in medication during the study.
• Participation in other non-pharmacological conservative therapies (e.g., hydrotherapy, electrotherapy, manual therapy, exercise, dry needling) during the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06616181 · UValladolid02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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