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CTRI Number  CTRI/2025/03/083197 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluating the effectiveness of a combined low-level light therapy and structured exercises on pain, sleep and quality of life in fibromyalgia syndrome 
Scientific Title of Study   Effectiveness of Combined Photobiomodulation and Structured Exercise-Based Rehabilitation on Pain, Sleep and Quality of Life in Fibromyalgia Syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swathi G A 
Designation  PhD Scholar 
Affiliation  Manipal college of Health Professions 
Address  Centre for Podiatry & Diabetic Foot Care and Research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  6361178152  
Fax    
Email  swathi.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr G Arun Maiya 
Designation  Professor, Department of Physiotherapy, Dean, Manipal College of Health Professions 
Affiliation  Manipal college of Health Professions 
Address  Centre for Podiatry & Diabetic Foot Care and Research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr G Arun Maiya 
Designation  Professor, Department of Physiotherapy, Dean, Manipal College of Health Professions 
Affiliation  Manipal college of Health Professions 
Address  Centre for Podiatry & Diabetic Foot Care and Research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Source of Monetary or Material Support  
Centre for Podiatry & Diabetic Foot Care and Research and Kasturba Hospital  
 
Primary Sponsor  
Name  Indian council of social science research 
Address  Research Project Division Indian Council of Social Science Research, JNU Institutional Area, Aruna Asaf Ali Marg, New Delhi – 110067 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SWATHI G A  Centre for Podiatry and Diabetic Foot Care and Research  Department of physiotherapy,Room No. 4, N1 1 st floor, N block , Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA 		 6361178152

swathi.mchpmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M797||Fibromyalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Standard medical care, No Structured exercise, Photobiomodulation sham irradiated  
Intervention  Photobiomodulation and Exercise based rehabilitation  Photobiomodulation therapy:5 days per week 2 weeks Total energy per point: 4 Joule per sq.cm Mode: continuous Time per point: 2 minutes (20 minutes in total) Relaxation techniques: breathing exercises Exercises will be flexibility, strength training, and aerobic training, 5 days per week for 6 weeks in institutional setup followed by 18-week home exercise program  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American college of Rheumatology 2016 criteria
Able to understand English / kannada
 
 
ExclusionCriteria 
Details  Uncontrolled systemic diseases, Neoplasia
Neurological conditions
Pregnancy
People diagnosed with psychiatric disorder (undergoing psychiatric treatment)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analog Scale
Pressure Pain Threshold
Pittsburgh Sleep Quality Index
WHO Health-Related Quality of Life-Bref
 		 baseline, 12th week of intervention and follow-up will be done at 24th week  
 
Secondary Outcome  
Outcome  TimePoints 
Fibromyalgia Impact Questionnaire, Revised
Fatigue Severity Scale
 		 baseline, 12th week of intervention and follow-up will be done at 24th week 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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