Effect of Transcranial Static Magnetic Field Stimulation Over the Primary Motor Cortex in Fibromyalgia Syndrome: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change from Self-reported pain intensity
研究概览
简要总结
The main objective is to know if the transcranial static magnetic field stimulation (tSMS) reduces the perception of pain in patients with fibromyalgia and its effect on health-related quality of life. In addition, it will seek to limit the parameters necessary to achieve efficiency with the technique.
详细描述
Background:
Various non-invasive brain stimulation techniques have been successfully tested in fibromyalgia syndrome (FMS). Transcranial static magnetic field stimulation (tSMS) is a new, portable and inexpensive non invasive brain stimulation (NIBS) technique that has shown security, biological effects, and therapeutical effects in some pathologies. Some studies have studied its effect in pain central processing, our aim is to study its effect on FMS. The safety that tSMS has demonstrated in several clinical trials opens doors to future clinical trials that will extend its clinical utility.
Objectives:
To investigate the effect of tSMS on pain in patients with FMS, using subjective and objective assessment measures. Identify dose response to the treatment to limit the parameters required to achieve effectiveness with the technique.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Formal diagnosis of fibromyalgia syndrome (FMS).
- •No change in the last 4 weeks on their standard treatment.
- •They must have pain for more than 6 months (at least 4 on the VAS scale).
- •Score on the fibromyalgia impact questionnaire (FIQ) greater than 39.
排除标准
- •Presence of concomitant autoimmune or hematologic diseases.
- •Neuropsychiatric disorders.
- •Pacemakers or neurostimulators implants.
- •Substance abuse or other pathologies that can explain chronic pain.
- •Pregnant or lactating women.
- •Those who are receiving any other type of physiotherapy treatment.
结局指标
主要结局
Change from Self-reported pain intensity
时间窗: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week) and 3 months from the last session (16th week)
Self-reported pain intensity evaluated by the Visual Analogue Scale (VAS).
Change from Self-reported quality of life
时间窗: At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week)
Self-reported quality of life evaluated by the Fibromyalgia Impact Questionnaire (FIQ).
次要结局
- Change from Global health(At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week))
- Change from Cognitive impairment(At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week))
- Change from Confidence in the treatment(After the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week))
- Change from Physical activity(After the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week) and 3 months from the last session (16th week))
- Change from Depression(At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week))
- Change from Self-reported catastrophizing(At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week))
- Change from Sleep(At the start of the study (at baseline, 0 week), after the 10th session (at the end of the second week), after 20th session (at the end of the fourth week), 1 month from the last session (8th week)) and 3 months from the last session (16th week))
研究者
JJ JIMENEZ-REJANO
PhD
University of Seville