Effects of Anodal TDCS Applied Over M1 and DLPFC Combined with a Telerehabilitation Exercise Program in Patients with Fibromyalgia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Pain intensity
研究概览
简要总结
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.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Anodal tDCS over M1 + telerehabilitation
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.
Telerehabilitation Exercise: 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 exercise 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 through video and weekly phone contact.
干预措施: Anodal tDCS over M1 (Device)
Anodal tDCS over M1 + telerehabilitation
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.
Telerehabilitation Exercise: 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 exercise 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 through video and weekly phone contact.
干预措施: Exercise telerehabilitation (Behavioral)
Anodal tDCS over DLPFC + telerehabilitation
tDCS over DLPFC: The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC) (F3), and the cathode will be positioned over the contralateral supraorbital area (F8). Once the electrodes are positioned, active tDCS will be applied at 2mA for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.
Tele-rehabilitation Exercise: 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 exercise 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 through video and weekly phone contact.
干预措施: Anodal tDCS over DLPFC (Device)
Anodal tDCS over DLPFC + telerehabilitation
tDCS over DLPFC: The anode will be placed over the left dorsolateral prefrontal cortex (DLPFC) (F3), and the cathode will be positioned over the contralateral supraorbital area (F8). Once the electrodes are positioned, active tDCS will be applied at 2mA for 20 minutes per session, with 30-second initial and final ramp-ups. One session will be administered per week for 12 weeks.
Tele-rehabilitation Exercise: 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 exercise 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 through video and weekly phone contact.
干预措施: Exercise telerehabilitation (Behavioral)
sham-tDCS + telerehabilitation
Sham tDCS: The same electrode placement protocol used for the active tDCS M1 group will be followed in this group. Stimulation will begin with a 30-second ramp-up to reach an intensity of 2 mA, immediately followed by a 30-second ramp-down to 0 mA. This stimulation will be repeated at the beginning and end of the session. Similar to the active tDCS groups, each session will last 20 minutes.
Telerehabilitation Exercise: 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 exercise 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 through video and weekly phone contact.
干预措施: Exercise telerehabilitation (Behavioral)
结局指标
主要结局
Pain intensity
时间窗: At pre-intervention, at weeks 12 and 24.
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will indicate their pain intensity by placing a perpendicular mark on a 100 mm straight line, where the left end represents \'no pain\'; and the right end represents \'the worst imaginable pain\'. Pain intensity is quantified by measuring the distance in mm from the left end of the line using a ruler.
次要结局
- Pain mechanosensitivity(At pre-intervention, at weeks 12 and 24.)
- Fatigue(At pre-intervention, at weeks 12 and 24.)
- Sleep Quality(At pre-intervention, at weeks 12 and 24.)
- Pain Catastrophizing(At pre-intervention, at weeks 12 and 24.)
- Isometric Strength(At pre-intervention, at weeks 12 and 24.)
- Exercise Adherence(At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12.)
- 6-Minute Walk Test(At pre-intervention, at 12 and 24 weeks.)
- 30-second Chair Stand Test(At pre-intervention, at weeks 12 and 24.)
- Fibromyalgia Impact(At pre-intervention, at weeks 12 and 24.)
研究者
Ignacio Hernando Garijo
PhD physiotherapist
University of Valladolid