Effect of a Functional Exercise Program Associated With Low Level Laser Therapy on Pain, Functional Capacity and Quality of Life in Individuals With Fibromyalgia: A Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Pain assessed by Visual Analogue Scale
研究概览
简要总结
The purpose of this study is to investigate the effects of a functional exercise program associated with Low Level Laser Therapy (LLLT) on pain, functional capacity and quality of life of individuals with fibromyalgia. Half of participants will receive functional exercise and LLLT, while the other half will receive functional exercise and placebo LLLT.
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
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •being female;
- •age between 30 and 50 years;
- •have an ovulatory cycle;
- •height between 1.50m and 1.80m, body mass between 50 and 80 kg and BMI in the range of 18.5 to 29.9 kg / m2;
- •present a clinical diagnosis of fibromyalgia, signed by a rheumatologist according to the current criteria of the American College of Rheumatology;
- •is at least 6 months without any physical exercise;
- •do not present musculoskeletal conditions that prevent them from performing the evaluation and proposed physical activity, except FM;
- •not having diabetes mellitus and uncontrolled blood pressure;
- •they do not present an inflammatory rheumatic condition or serious cardiovascular and / or pulmonary disease that prevents them from performing the evaluation and the proposed physical activity;
- •Not having psychiatric illness or having malignant tumors;
- •is not pregnant
- •did not present dengue, zika or chikungunya in the last year;
- •and finally not to be hypersensitive to light.
排除标准
- •not attend for more than two consecutive exercise sessions
- •at any time and for any reason expressing an intention to leave the study
- •present a health problem that prevents them from continuing to carry out the proposed exercises
研究组 & 干预措施
Laser Group
The subjects participated in a functional exercise program associated with low level laser therapy applied in the quadriceps, hamstrings and triceps sural
干预措施: Functional Exercise (Other)
Laser Group
The subjects participated in a functional exercise program associated with low level laser therapy applied in the quadriceps, hamstrings and triceps sural
干预措施: Low Level Laser Therapy (Radiation)
Placebo Group
The subjects participated in a functional exercise program associated with placebo low level laser therapy applied in the quadriceps, hamstrings and triceps sural
干预措施: Functional Exercise (Other)
Placebo Group
The subjects participated in a functional exercise program associated with placebo low level laser therapy applied in the quadriceps, hamstrings and triceps sural
干预措施: Placebo Low Level Laser Therapy (Radiation)
结局指标
主要结局
Pain assessed by Visual Analogue Scale
时间窗: Pain assessment two months after the intervention
Assessed by Visual Analogue Scale
Pain assessed by Widespread Pain Index
时间窗: Pain assessment two months after the intervention
Assessed by Widespread Pain Index
次要结局
未报告次要终点
研究者
Wouber Hérickson de Brito Vieira
PhD
Universidade Federal do Rio Grande do Norte