A New Rehabilitation Tool in Fibromyalgia: Efficacy of Perceptive Rehabilitation Versus Group Exercises on Pain and Function: a Clinical Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 主要终点
- Change of Fibromyalgia Assessment Scale (FAS) from baseline to 12 weeks
研究概览
简要总结
The aim of the investigators study was to measure reductions in chronic pain in female patients with Fibromylgia comparing individual proprioceptive rehabilitation treatments with perceptual surfaces to a group exercises rehabilitation. Fibromyalgia is a generalized chronic pain condition that is usually accompanied by fatigue, sleep disturbance and psychological and cognitive alterations.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 1990 and 2010)
- •Subjects aged between 18 and 60 years
- •visual analog scale (VAS) for pain > 5
排除标准
- •presence of concomitant autoimmune diseases
- •psychiatric disorders
- •other causes of chronic pain
- •other diseases that prevented physical loading
- •severe scoliosis or kyphoscoliosis
- •surgery of the spine
- •vertebral fractures
- •sciatic pain
- •enrolled in another type of physical therapy program
- •myocardial infarction
- •lower extremity arterial disease
- •major neurological problems
- •gastrointestinal disease
- •chronic respiratory disease
- •kidney disease
- •poor vision
结局指标
主要结局
Change of Fibromyalgia Assessment Scale (FAS) from baseline to 12 weeks
时间窗: baseline, 4 weeks, 12 weeks
It is a simple and rapidly implemented index, consisting of a pain map, called the Self-Assessment Pain Scale (SAPS) (in which the patient is asked to indicate how much pain he suffered in the previous week in 16 areas of the body, with scored from 0 to 3), and 2 scales (between 0 and 10) that evaluate fatigue and quality of sleep, scored from 0-10. The FAS allows physicians to obtain reliable information concerning the course of the disease and is sufficiently sensitive to alert them in case of deterioration.
次要结局
- Change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
研究者
Teresa Paolucci
medical director
University of Roma La Sapienza