Effectiveness of Combined Photobiomodulation and Structured Exercise-Based Rehabilitation on Pain, Sleep and Quality of Life in Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- WHO Health-Related Quality of Life-Bref
研究概览
简要总结
This study is a randomized, clinical trial with an objective to find out the efficacy of combined photobiomodulation and structured exercise-based rehabilitation on pain, sleep, and quality of life in fibromyalgia syndrome. In this study, participants will be included based on inclusion criteria. Also, patients will be screened using ACR criteria for fibromyalgia 2016, and those who fulfill the criteria will be included in this study. The primary measures will be the visual analog scale, pain pressure threshold, Pittsburg sleep scale, and WHO health-related quality of scale (Bref). The secondary measures will be fatigue severity and fibromyalgia impact questionnaire—revised. All the outcome measures will be measured at the baseline 12 weeks post-intervention, followed by 24 weeks followup. Data will be analyzed using statistical software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •American college of Rheumatology 2016 criteria Able to understand English / kannada.
排除标准
- •Uncontrolled systemic diseases, Neoplasia Neurological conditions Pregnancy People diagnosed with psychiatric disorder (undergoing psychiatric treatment).
结局指标
主要结局
WHO Health-Related Quality of Life-Bref
时间窗: baseline, 12th week of intervention and follow-up will be done at 24th week
Visual Analog Scale
时间窗: baseline, 12th week of intervention and follow-up will be done at 24th week
Pressure Pain Threshold
时间窗: baseline, 12th week of intervention and follow-up will be done at 24th week
Pittsburgh Sleep Quality Index
时间窗: baseline, 12th week of intervention and follow-up will be done at 24th week
次要结局
- Fibromyalgia Impact Questionnaire, Revised(Fatigue Severity Scale)
