The Effects of Pain Neuroscience Education Plus Exercise in the Management of Fibromyalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 主要终点
- Change from Baseline function at 1 month
研究概览
简要总结
Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a female to male ratio of 3:1) over 50 years of age with low education level and low socioeconomic status, living in rural areas. High direct medical costs and significant indirect costs of this condition can't be ignored.
详细描述
Study design and setting: The design of the present study will be a randomized controlled trial with 2 follow-ups (one week and one month after intervention) that will be performed between May 2017 and June 2017 in one private clinic in Malaga, Spain. The outcomes will be assessed at baseline (t1), one week after intervention (t2), and one moth after intervention (t3). Written informed consent will be acquired for all participants prior to their participation. The study will be implemented and reported in line with the CONSORT statement.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-70 years.
- •Willing and able to participate
- •Diagnosis of Fibromyalgia
排除标准
- •Systemic diseases
- •Pain and function due to other rheumatic disorders such as: osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.
结局指标
主要结局
Change from Baseline function at 1 month
时间窗: 1 month
This outcome will be measured with the pain disability index (PDI)
Change from Baseline pain at 1 month
时间窗: 1 month
This outcome will be measured with the numerical pain rating scale (NRS)
次要结局
- Change from Baseline self-efficacy at 1 moths(1 month)
研究者
Alejandro Luque-Suarez
PhD
University of Malaga