Effects of Nutritional Strategies or Manual Therapies on Physical and Psychological Parameters in Women With Fybromyalgia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Sleep Quality
研究概览
简要总结
The study had two objectives. The first main aim was to analyze the effects of tryptophan and magnesium-enriched Mediterranean diet on psychological variables (trait anxiety, self-image, mood state, eating disorders) and sleep effects in women with fibromyalgia. Our hypothesis, based on previous positive effects of tryptophan and magnesium supplementation by separate in this population, may improve psychological health and regulate sleep disruptions. The second aim was to assess the effectiveness of a manual therapy technique performed with moderate digital pressure in fibromyalgia patients on the variables of fatigue, pain, sleep, anxiety and mood. It was done to provide an alternative treatment to pharmacological therapies for fibromyalgia patients and to provide new evidence on the effects of manual therapy in fibromyalgia patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 40-60 with fibromialgia (officially diagnosed).
排除标准
- •Women used analgesics, vitamins containing supplements, and or other drugs for the treatment of fibromyalgia symptoms, or participation in other clinical trials.
- •Women that be performing simultaneously to this study some other physical therapy or physical exercise treatment. Not having sufficient cognitive level to collaborate in the study or not having the possibility of attending the established sessions.
结局指标
主要结局
Sleep Quality
时间窗: 4 - 16 weeks
Sleep Quality assessment: Athenas Insomnia Scale.
Anxiety trait
时间窗: 4 - 16 weeks
Anxiety trait assessment: Stay Trait Anxiety Inventory.
Mood state
时间窗: 4 - 16 weeks
Mood state assessment: Profile of Mood State inventory.
Fatigue severity
时间窗: 4 - 16 weeks
Fatigue severity assessment: Fatigue Severity Scale
Pain perception
时间窗: 4 - 16 weeks
Pain perception assessment: Visual Analogical Scale
Sleep quality
时间窗: 4 - 16 weeks
Sleep quality assessment: Pittsburgh Sleep Quality Index
次要结局
- Body composition(4 - 16 weeks)
研究者
Prof. Dr. Alejandro Martínez-Rodríguez
Assistant Professor
University of Alicante