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CTRI Number  CTRI/2025/06/089201 [Registered on: 20/06/2025] Trial Registered Prospectively
Last Modified On: 19/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness And Comparison Of Myofascial Release Versus Muscle Energy Technique In Managing Non-Specific Sub-Acute Low Back Pain. 
Scientific Title of Study   A Comparative Study To Evaluate The Effectiveness Of Myofascial Release Versus Muscle Energy Technique In Non-Specific Sub-Acute Low Back Pain. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Piyush Sharma 
Designation  PhD Scholar 
Affiliation  Mahatma Gandhi University Of Medical Sciences and Technology 
Address  Physiotherapy OPD,RD Block 1st Floor, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University Of Medical Sciences And Technology, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8619307150  
Fax    
Email  Drpiyush@mgumst.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Lokesh Sharma 
Designation  Professor 
Affiliation  Mahatma Gandhi University Of Medical Sciences and Technology 
Address  RD Block First Floor, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University Of Medical Sciences And Technology, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  7891716403  
Fax    
Email  drlokeshsharma2@mgumst.org  
 
Details of Contact Person
Public Query  
Name  Dr Lokesh Sharma 
Designation  Professor 
Affiliation  Mahatma Gandhi University Of Medical Sciences and Technology 
Address  RD Block First Floor, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University Of Medical Sciences And Technology, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  7891716403  
Fax    
Email  drlokeshsharma2@mgumst.org  
 
Source of Monetary or Material Support  
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University Of Medical Sciences And Technology, Jaipur, Rajasthan, India 302022  
 
Primary Sponsor  
Name  Piyush Sharma 
Address  2 CH 8, Kamla Nehru Nagar, Ajmer Road, By Pass, Bhankrota, Jaipur, Rajasthan 302024  
Type of Sponsor  Other [Self] 
 
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 
Dr Lokesh Sharma   Mahatma Gandhi Hospital  Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University Of Medical Sciences And Technology, Jaipur
Jaipur
RAJASTHAN 		 7891716403

drlokeshsharma2@mgumst.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Muscle Energy Technique  Group received a treatment program that included a manual technique called Muscle energy Technique by two methods Post isometric relaxation Gentle muscle contractions followed by stretching held for 5 seconds. Post-facilitation stretches Strong muscle contractions followed by a quick stretch held for 5 seconds. Treatment details Patients performed Muscle Energy Technique exercises in both lying and sitting positions. They did 1 set of 3 repetitions per exercise, 3 times a week for 3 to 6 weeks with rest days in between. MET was combined with traditional physical therapy. MET Technique Patients would contract a specific muscle agonist with low effort for a few seconds. A therapist would resist this contraction with equal force. After relaxing, the therapist would gently stretch the muscle to a new limit. This cycle contract, resist, relax, stretch was repeated 2-3 times per muscle. Tensor Fascia Lata Gastrocnemius Hamstrings Erector spinae Quadratus lumborum Piriformis 
Intervention  Myofascial Release   The self-myofascial release technique was performed by the patient using a lacrosse ball, for three days per week over a total period of six weeks. Tennis balls, golf balls, and lacrosse balls are excellent for this type of massage because their smaller surface area compared to foam rollers allows for more precise targeting of specific muscles or tissue areas. Procedure Frequency 3 days per week Duration 3 to 6 weeks Tool Lacrosse ball Alternatively tennis ball or golf ball Positioning Supine, sitting, or standing Myofascial Tracks Tensor Fascia Lata Gastrocnemius Hamstrings Erector spinae Quadratus lumborum Piriformis Technique 1. Application Massage each of the four myofascial tracks with the lacrosse ball. 2. Repetitions Perform the technique in 3 repetitions, with 30 seconds of rest between reps. Each repetition lasts for 30 seconds per myofascial track. 3. Pain Points When a pain point is found, hold the position for 10-15 seconds. The degree of pressure applied should be 7 out of 10 on the discomfort scale. 4. Session Duration Each self-massage session lasts for a total of 15 minutes. 5. Breathing Instruct the patient to breathe slowly and deeply throughout the massage to promote relaxation. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The inclusion criteria for this study involve targeting individuals between the ages of 30 to
60 who have received a diagnosis of non-specific sub-acute low back pain.
Specifically, participants must experience pain localized between the lower rib margin and
the inferior gluteal folds, indicative of sub-acute low back pain symptoms.
Crucially, the duration of this pain should fall within the sub-acute phase, lasting between
3 to 6 weeks.
By focusing on this specific timeframe, the study aims to capture individuals who have
moved beyond the acute stage of pain but have not yet progressed to sub-acute low back
pain.  
 
ExclusionCriteria 
Details  Exclude individuals with specific medical conditions
Spinal stenosis.
Herniated disc.
Sciatica.
Recent trauma.
Pregnancy.
Recent surgeries.
Potts infection.
Patients taking skeletal muscle relaxants and analgesics will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pain intensity - measured using Visual Analog Scale (VAS)
2. Functional Disability - Assessed using the Oswestry Disability Index
3. Range of motion (ROM) - Lumber spine flexion, extension, rotation & lateral flexion
4. Patients-reported outcome measures (PROMs) - Quality of life 		 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pain intensity - measured using Visual Analog Scale (VAS)
2. Functional Disability - Assessed using the Oswestry Disability Index 		 3 weeks 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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   Phase 3 
Date of First Enrollment (India)   10/07/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   128 subjects will be selected according to the inclusion criteria from Outpatient department of Physiotherapy and Orthopedics of Mahatma Gandhi Hospital, Jaipur and written consent will be taken before participation in this study. These subjects will be allocated in two groups
Group A (n=64)     Group B (n=64)

Group A will receive Myofascial Release 

Group B will receive Muscle Energy Technique.

both groups participants will receive conventional physiotherapy treatment prior to treatment procedure. 

6 weeks of treatment will be given and data analysis will be done  to see the effectiveness of the treatment and comparison is done through appropriate statistical tool.
 
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