Effects of Therapeutic Exercise in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quality of Sleep
研究概览
简要总结
Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and some biochemical markers. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.
The objective of this trial is to evaluate if therapeutic exercise is effective on fatigue, pain threshold, quality of life, quality of sleep, pain coping and biochemical and genetic markers.
For this purpose, the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).
Patients included one group receiving exercise therapy consisting of 3 treatment sessions a week over 10 weeks.
The variables are measured at the beginning and end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed medically with Fibromyalgia
- •Diagnosed according to the American College of Rheumatology criteria
- •Agreement to attend to treatment sessions
排除标准
- •Any kind of contraindications for physical activity
- •Other kind of diseases that could limit the intervention
- •Previous surgery last year
- •Medication modifications in the last 3 months
研究组 & 干预措施
Exercise Therapy
干预措施: Therapeutic Exercise (Other)
结局指标
主要结局
Quality of Sleep
时间窗: through study completion, an average 10 weeks
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Pain intensity
时间窗: through study completion, an average 10 weeks
VAS
Pain intensity
时间窗: Baseline
VAS
Quality of Sleep
时间窗: Baseline
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
次要结局
- Analysis of tryptophan metabolites(through study completion, an average 10 weeks)
- Pressure pain threshold(through study completion, an average 10 weeks)
- Central sensitization(through study completion, an average 10 weeks)
- Pressure pain threshold(Baseline)
- Central sensitization(Baseline)
- Analysis of tryptophan metabolites(Baseline)
研究者
Sandra Jiménez
University of Valladolid Faculty of Health Sciences
Universidad de Zaragoza