Fibromyalgia: Impact on Pain, Quality of Life of a Complementary Therapy on Primary Health Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
This study aims to evaluate the effectiveness of a complementary therapy using Yoga within the scope of First Health Care in Portugal, in pain control, quality of life and well-being of the patients with Fibromyalgia. It also, pretends to assess the viability and to identify the barriers to this sort of therapy in the context of Primary Health Care.
详细描述
Fibromyalgia is a chronic and debilitating pain syndrome characterized by widespread and persistent pain, also affecting sleep quality and cognitive function. It is estimated to affect 3.6% of the population; however, since it is a condition that is often underdiagnosed, the actual numbers may be higher. It is also an incurable disease, so treatment is based on symptom management through pharmacological therapy, which is not always effective. Due to the inadequacy of pharmacological therapy, there is a need for complementary therapies, and despite the limited number of studies conducted in this area, some therapies based on meditative movement (notably yoga) are beginning to emerge, with beneficial effects reported on pain management and quality of life in these patients. Therefore, this study aims to investigate the benefits and feasibility of this type of intervention at the Primary Health Care level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Users of the Family Health Unit diagnosed with Fibromyalgia;
- •With cognitive capacity to answer the questionnaire;
- •With physical capacity to take part in Yoga classes.
排除标准
- •people under 18 years old.
研究组 & 干预措施
Control group
Group used as comparison.
Intervention group
Yoga practioner group with a certified teacher, 3 times a week during 3 months.
干预措施: Yoga (Other)
结局指标
主要结局
Quality of Life
时间窗: at the beggining and up to 3 months
EQ-5D
Pain
时间窗: at the beggining and up to 3 months
Visual scale from 0 to 10 to measure pain
Global perception of change
时间窗: up to 3 months
Patient Global Impression of Change scale (portuguese validated version) 1 to 7 (1 is the worst, 7 is the best)
次要结局
- Well-being(at the beggining and up to 3 months)
- Benefits perceived(up to 3 months)
- Difficulties perceived(up to 3 months)
- Replicability and ease of introducing treatment in the context of the Portuguese national health service(up to 3 months)
研究者
Ines Rosendo
PhD
University of Coimbra