Comparison of the Effects of Connective Tissue Massage and Extracorporeal Shock Wave Therapy (ESWT) in Patients With Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 3.1. Pain (Mcgill)
研究概览
简要总结
Massage therapy, one of the complementary and alternative treatments, is commonly used for fibromyalgia syndrome (FMS). It may help improve pain, anxiety, depression, and sleep disorders through the complex interaction of physical and mental mechanisms. Although studies have investigated massage and extracorporeal shock wave therapy (ESWT) separately, there is currently no study directly comparing these two treatment methods.
In this study, we plan to use massage therapy to reduce pain, stiffness, fatigue, and sleep difficulties in individuals with FMS. The aim is to evaluate the effects of both connective tissue massage and ESWT on fibromyalgia symptoms, with a focus on pain, fatigue, sleep disturbances, health status, and quality of life.
We also aim to compare the effectiveness of these two non-pharmacological interventions in enhancing general well-being and encouraging participation in daily life. Additionally, we hope this research will contribute to clinical practice by evaluating the potential benefits of connective tissue massage, a safe and cost-effective method.
详细描述
General Information
Fibromyalgia syndrome (FMS) is one of the most common conditions affecting muscles and is characterized by pain, stiffness, and tenderness in muscles, tendons, and joints. Despite years of research, no definitive cause or pathophysiology of FMS has been identified. It is believed that genetic and environmental factors, as well as both peripheral and central mechanisms, may play a role in the development of widespread pain and pain sensitivity in individuals with fibromyalgia. FMS is often associated with symptoms such as decreased physical capacity, fatigue, sleep disorders, gastrointestinal issues, and psychiatric conditions including depression. Pain and other symptoms interfere with daily functioning, work, and social activities, resulting in reduced quality of life.
Various treatment approaches are available for patients with FMS. Both pharmacological and non-pharmacological methods are used in its management. Treatment options include medications such as tricyclic antidepressants, exercise, acupuncture, manual/manipulative therapies, and mind-body approaches. Studies on exercise suggest that moderate-to-high intensity physical activity may be effective. Antidepressants have been found helpful in increasing serotonin levels and thereby alleviating fibromyalgia symptoms. Chiropractic care and acupuncture have also been explored as potential management strategies.
Connective Tissue Massage (CTM) Massage therapy is widely used as a complementary and alternative treatment in fibromyalgia. Through the complex interaction of physical and psychological mechanisms, it may improve pain, anxiety, depression, and sleep disturbances. When applied to soft tissues and connective tissue, massage may induce local biochemical changes that contribute to improved muscle flexibility and modulation of local blood and lymphatic circulation.
Connective tissue massage, one of the manual therapy techniques used for FMS, involves short and long tractions on the connective tissue that may mechanically stimulate mast cells. This may help reduce sympathetic activity and promote vasodilation. As a result, parasympathetic activity increases and supports improved circulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of fibromyalgia syndrome
- •Aged between 18 and 60 years
- •Female gender
- •Symptoms present for at least 6 months
- •Willing to participate in the study
排除标准
- •History of rheumatologic, neurologic, psychiatric, or systemic disease
- •Pregnancy or lactation
- •Prior treatment with massage or ESWT
- •History of acute infection, trauma, or surgery
- •History of cancer
- •Use of painkillers or antidepressants
- •Any medical condition that prevents participation in physical activity
结局指标
主要结局
3.1. Pain (Mcgill)
时间窗: 6 WEEK
Higher scores indicate more severe pain. Description: Consists of 15 pain descriptors (11 sensory, 4 affective), each rated on a scale from 0 (none) to 3 (severe), plus a Visual Analog Scale (VAS) and Present Pain Intensity (PPI)
次要结局
- Fibromyalgia Impact Questionnaire(6 week)
研究者
Ilknur Mazı
Principal Investigator
Istanbul University - Cerrahpasa
