跳至主要内容
临床试验/CTRI/2025/03/083197
CTRI/2025/03/083197尚未招募不适用

Effectiveness of Combined Photobiomodulation and Structured Exercise-Based Rehabilitation on Pain, Sleep and Quality of Life in Fibromyalgia Syndrome

Indian council of social science research1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年7月4日最近更新:

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)

研究者

申办方类型
Government funding agency

研究点 (1)

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