Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment
研究概览
简要总结
The purpose of this study is to determine the analgesic effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation exercises in patient suffering from fibromyalgia.
A double blind clinical trial with two randomized parallel groups:
- Placebo rTMS and rehabilitation exercise
- Active rTMS and rehabilitation exercise
详细描述
Fibromyalgia is the most frequent chronic diffuse painful disease (3 to 4% of the general population).
Analgesic drugs are widely used in fibromyalgia, pain being the main symptom. However the effectiveness of analgesic drugs is often insufficient.
Among non-drug therapies, rehabilitation exercise plays an important role with a special interest in terms of the quality of life, strain and pain.
More recently the Transcranial Magnetic Stimulation effects have been evaluated in patients suffering from fibromyalgia with a statistically significative analgesic effect.
Both rehabilitation exercise and Transcranial Magnetic Stimulation (rTMS) have shown their respective analgesic effectiveness in fibromyalgia. It now seems important to evaluate the combination of these two therapies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary fibromyalgia according to the American College of Rheumatology
- •no contraindication to rehabilitation exercise
- •pain with VAS > 4 during at least six months
- •FIQ score > 50
- •no change in drug therapy over the last month
- •affiliation to French Health Service
排除标准
- •BMI > 35kg/m²
- •patient who has already benefited from rTMS
- •rTMS contraindication
- •restless legs symptom
- •patient suffering from major depression
- •patient suffering from inflammatory rheumatism, autoimmune disease, other chronic pain pathology
- •sleep apnea syndrome
- •no contraindication to rTMS or MRI
- •pregnant women
研究组 & 干预措施
active rTMS + rehabilitation exercise
14 weeks of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
干预措施: active rTMS + rehabilitation exercise (Device)
placebo rTMS + rehabilitation exercise
14 weeks of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise
干预措施: placebo rTMS+ rehabilitation exercise (Device)
结局指标
主要结局
Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment
时间窗: Daily average VAS at baseline, week 2, week 4, week 8, week 14
Patient will note down each day the VAS for the last 24 hours.
次要结局
- Change from base line in quality of life at 14 weeks and 26 weeks(At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program)
- Change from base line in depression assessment at 14 weeks and 26 weeks(at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program)
- Change from baseline in Covi's anxiety scale(at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program)
- Change from baseline in sleep quality at 14 weeks abd 26 weeks(At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program)
- Change from baseline in neuromuscular fatigability at 14 weeks and 26 weeks(At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program)
- Change from baseline in cardiac variability at 14 weeks and 26 weeks(At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program)
- Evolution of the analgesic effect after the end of the program(Daily average VAS at the end (14 weeks) and 26 weeks after the end of the program)