Effect of Revival Soy on Fibromyalgia Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To gather preliminary data on whether dietary soy supplement can improve quality of life in patients with fibromyalgia as measured by the Fibromyalgia Impact Questionnaire (FIQ) and the Center for Epidemiologic Studies Depression Scale (CES-D).
研究概览
简要总结
Fibromyalgia is characterized by widespread pain that can lead to significant patient dysfunction and economic burden to society. The management of patients with fibromyalgia is difficult and no single treatment modality has been successful. We propose to study the effect of dietary soy supplement on quality of life associated with fibromyalgia.
详细描述
Fibromyalgia syndrome is a chronic, generalized pain syndrome that affects the musculoskeletal system (1). This syndrome is typically diagnosed in patients who experience generalized musculoskeletal pain and have excessive tenderness in at least 11 of 18 specific points (2). Although the primary cause of fibromyalgia syndrome is unclear, a growing body of evidence indicates that the widespread pain associated with this syndrome is due to abnormalities in the central nervous system. Therefore, drug therapy for fibromyalgia syndrome is most often aimed at the central nervous system and includes tricyclic antidepressants, selective serotonin reuptake inhibitors, dual serotonin and norepinephrine reuptake inhibitors, analgesics, and anticonvulsants (1).
In addition to medical therapies, complementary and alternative medicine therapies have been used to treat fibromyalgia syndrome symptoms (3). Soy is a widely used dietary supplement that has not been previously tested for treating fibromyalgia syndrome.
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 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men age 18 - 76
- •Able to understand and sign a consent form
- •Able to participate fully in all aspects of the study
- •Currently participating in Mayo Clinic's Fibromyalgia Treatment Program
排除标准
- •Pregnant or lactating women
- •Allergy to soy or other study product ingredients
- •Diagnosis of bipolar disorder, schizophrenia or dementia
- •Diagnosis of diabetes mellitus or inflammatory bowel disease
- •Presently on soy product or use of soy within the last 30 days
结局指标
主要结局
To gather preliminary data on whether dietary soy supplement can improve quality of life in patients with fibromyalgia as measured by the Fibromyalgia Impact Questionnaire (FIQ) and the Center for Epidemiologic Studies Depression Scale (CES-D).
时间窗: 6 Weeks
次要结局
- To assess the feasibility of recruiting 50 patients with fibromyalgia into a study of using a dietary supplement.(3 Months)
研究者
Dietlind Wahner-Roedler
Principal Investigator
Mayo Clinic