Effects of Pain Education and Therapeutic Exercise for Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Pain Intensity: VAS
研究概览
简要总结
Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and psychological problems. 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 patient education plus therapeutic exercise is more effective in pain intensity, fatigue, function, strength, pain threshold, anxiety, depression, quality of life, quality of sleep, kinesiophobia, pain coping and biochemical and genetic markers and compared to therapeutic exercise.
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 are randomized into 2 groups one receive education of pain neurophysiology plus exercise therapy and the other only exercise therapy. Groups receive 3 treatment sessions a week over 10 weeks.
The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session.
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, Outcomes Assessor)
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
- •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
结局指标
主要结局
Pain Intensity: VAS
时间窗: through study completion, an average 10 weeks
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention
Fibromyalgia Impact Questionnaire
时间窗: through study completion, an average 10 weeks
The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) at the end of the intervention
次要结局
- Functional Capacity(through study completion, an average 10 weeks)
- body strength(through study completion, an average 10 weeks)
- Central sensitization(through study completion, an average 10 weeks)
- Fatigue(through study completion, an average 10 weeks)
- Quality of Sleep(Baseline)
- Quality of Sleep: Pittsburg Sleeping Questionnaire(through study completion, an average 10 weeks)
- Quality of life: HAQ(through study completion, an average 10 weeks)
- Pressure pain threshold(through study completion, an average 10 weeks)
- Anxiety and Depression(through study completion, an average 10 weeks)
- kinesiophobia(through study completion, an average 10 weeks)
研究者
Sandra Jiménez
Principal Investigator
Universidad de Zaragoza