A Multicenter, Randomized Study, Against Credible Factitious Intervention That Evaluates the Interest of Osteopathic Medicine in the Management of Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Evaluation of pain during the 6 weeks of osteopathic treatment
研究概览
简要总结
The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic treatment on patients with fibromyalgia.
详细描述
An osteopathic treatment could have a positive and durable effect on pain and quality of life on patients with fibromyalgia.
This technique, in addition to the standard treatment in a multidisciplinary care center, could be efficient by releasing muscle tension.
This is a 24 months multicenter (2 recruiting centers, 1 care center), randomized, and placebo-controlled study. The purpose is to evaluate the analgesic efficacy of a 6 weeks osteopathic treatment compared to a 6 week standard treatment on patients with fibromyalgia. It includes 6 osteopathic/standard sessions of 20 minutes (of one week apart), a follow-up at 3 months, 6 months and 12 months.
The primary aim of this study is to evaluate the pain after each osteopathic session, at the end of the 6 weeks treatment, and after each visit, judging by the patient's pain measured by a numeric scale (EVA).
The secondary aims of this study, based on clinical exams and questionnaires are to evaluate the quality of life, the patient activity and the sleep improvement after osteopathic treatment, and to investigate if osteopathic medicine improves fatigue, comorbidities, and decrease additional visits and medical investigations.
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, Investigator)
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
- •Patient Male or female aged at least of 18
- •Patient with fibromyalgia, according to the American College of Rheumatology (ACR) 1990 criteria, with a global level of pain of 50 over a 100 mm EVA scale
- •Patient suffering from fibromyalgia for over a year
- •Patient with stable medical/non medical treatment for at least 1 month before the recruitment
- •Patient referred to a medical center for a multidisciplinary approach
- •Patient who can be followed for at least 12 months after the end of the osteopathic sessions
- •Patient giving his informed consent to participate in the study
- •Patient affiliated to or beneficiary of social insurance
排除标准
- •Treatment by physical approach in progress or not older than 3 months : physiotherapy, kinesitherapy, rehabilitation or manual treatment (osteopathic or chiropractic care, manual medicine)
- •Unability to attend 6 sessions, meaning one weekly session, of osteopathy, at Hôtel Dieu
- •Severe psychiatric pathology : major depression, psychosis
- •Pregnancy or breast feeding
- •The patient is already included in another clinical study
- •Patient under judicial protection
研究组 & 干预措施
Osteopathy +
75 patients will make 6 osteopathic sessions
干预措施: Osteopathic treatment (Procedure)
Osteopathy -
75 patients will make 6 factitious osteopathic sessions
干预措施: Factitious osteopathic treatment (Procedure)
结局指标
主要结局
Evaluation of pain during the 6 weeks of osteopathic treatment
时间窗: 6 weeks
The assessment will be on the declarative of the patient. He will report every week the intensity of pain measured by a numeric scale (0 to 100).
次要结局
- Quality of life(1 year after osteopathic treatment)
- Pain(1 year after osteopathic treatment)
- Fatigue(1 year after osteopathic treatment)