Treating Fibromyalgia Pain With Shock-Waves: a Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Pain VAS
研究概览
简要总结
Fibromyalgia pain syndrome is a common debilitating condition which associates mainly generalised pain, emotional distress and cognitive symptoms. The etiology is unknown, and no specific treatment exists so far.
Lately, shock-waves have been used successfully to treat painful skeletal muscle, tendons and fascia, the investigators therefore hypothesize that shock-waves could be useful in alleviating Fibromyalgia pain.
Two similar groups of participants bearing the condition will be prospectively compared.
The first group will benefit from the application of shock-waves weekly for 12 weeks, the second will not.
The investigators intend to study if there is any difference in pain and quality of life between the two groups at the end of the three months.
详细描述
Fibromyalgia Pain Syndrome (FPS) is a common debilitating condition which associates mainly generalised pain, emotional distress and cognitive symptoms. The etiology is unknown, and no specific treatment exists so far.
It bears some similarities with another, more localised clinical condition : the Myofascial Pain Syndrome (MPS), which results in pain caused by, amongst others, muscular trigger points.
Lately, FPS and MPS have both been classified as belonging to a new, larger entity : Central Sensitivity Syndromes (CSS), in which a strong and chronic peripheral sensitive stimulus (like musculoskeletal pain) is believed to induce, after some time, an enhanced response of the central nervous system (CNS) towards that same stimulus, with the result that the stimulus will be felt more powerfully (central sensitization, CS). This is secondary to neuroplastic changes in the CNS, which are reversible to some extent.
Since shock-waves are effective to treat pain in MPS (by eliminating trigger points and thus restoring muscle and tissue function), and since MPS and FPS could be linked by a common pathophysiologic mechanism (CSS), the investigators hypothesize that shock waves could be beneficial in treating pain in FPS.
Two groups of 20 participants will be prospectively compared over a three month's period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American College of Rheumatology 2011 diagnostic criteria for Fibromyalgia met
- •Aged between 18 and 65 years
- •Informed Consent Form signed
排除标准
- •Known skeletal pathologies such as osteoarthritis of major joints and / or vertebrae, inflammatory states involving bones, joints, tendons or muscles, or previous heavy trauma directly causing the pain
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, carcinoma, cardiovascular disease, pulmonary insufficiency, etc.),
- •Coagulopathies, anticoagulant or corticosteroid based medication, thrombosis.
- •Psychological distress, psychosis, dementia
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Pregnancy
- •Enrolment of the investigator, his/her family members, employees and other dependent or vulnerable persons
结局指标
主要结局
Pain VAS
时间窗: 12 weeks
Horizontal visual analog scale for pain (pain intensity)
次要结局
- Apparent change in successive Pain Body Maps over time(12 weeks)
- Patient Global Impression of Change scale (PGIC)(12 weeks)
- Interference scale of the Body Pain Index (BPI)(12 weeks)
研究者
Dr Yves JACOT, MD
Director
Projet Suisse d'Assistance Medicale