Evaluating the effectiveness of a combined low-level light therapy and structured exercises on pain, sleep and quality of life in fibromyalgia syndrome

Not yet recruiting

Conditions: Fibromyalgia,

Registration Number: CTRI/2025/03/083197

Lead Sponsor: Indian council of social science research

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 72

Inclusion Criteria

American college of Rheumatology 2016 criteria Able to understand English / kannada.

Exclusion Criteria

Uncontrolled systemic diseases, Neoplasia Neurological conditions Pregnancy People diagnosed with psychiatric disorder (undergoing psychiatric treatment).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WHO Health-Related Quality of Life-Bref	baseline, 12th week of intervention and follow-up will be done at 24th week
Visual Analog Scale	baseline, 12th week of intervention and follow-up will be done at 24th week
Pressure Pain Threshold	baseline, 12th week of intervention and follow-up will be done at 24th week
Pittsburgh Sleep Quality Index	baseline, 12th week of intervention and follow-up will be done at 24th week

Secondary Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire, Revised	Fatigue Severity Scale

Trial Locations

Locations (1): Centre for Podiatry and Diabetic Foot Care and Research
🇮🇳
Udupi, KARNATAKA, India
Centre for Podiatry and Diabetic Foot Care and Research
🇮🇳Udupi, KARNATAKA, India
SWATHI G A
Principal investigator
6361178152
swathi.mchpmpl2024@learner.manipal.edu