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CTRI Number  CTRI/2025/02/080322 [Registered on: 11/02/2025] Trial Registered Prospectively
Last Modified On: 11/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Myofascial release for enhancing flexibility of back muscles and fascia in chronic low back pain - an ultrasound based study. 
Scientific Title of Study   Efficacy of Myofascial release in improving the flexibility of Erector Spinae and Thoracolumbar Fascia in subjects with Chronic Low Back Pain - a Sonoelastographic analysis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha J 
Designation  student  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty Of Physiotherapy, NO.1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116.

Chennai
TAMIL NADU
600116
India 
Phone  9384843645  
Fax    
Email  t0223004@sriher.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Angeline R 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty Of Physiotherapy, NO.1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116.

Chennai
TAMIL NADU
600116
India 
Phone  9943529400  
Fax    
Email  angelinejobin.75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Angeline R 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Faculty Of Physiotherapy, NO.1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116.

Chennai
TAMIL NADU
600116
India 
Phone  9943529400  
Fax    
Email  angelinejobin.75@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research, Faculty Of Physiotherapy, NO.1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116.  
 
Primary Sponsor  
Name  Manisha J 
Address  Sri Ramachandra Institute of Higher Education and Research, sri ramachandra nagar,porur,chennai -600116. 
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 Manisha J  Sri Ramachandra Institute of Higher Education and Research  Physical Rehabilitation Department,ground floor,New Block OPD,Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research[Deemed University] NO.1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116.
Chennai
TAMIL NADU 		 9384843645

t0223004@sriher.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE FOR STUDENTS PROJECTS  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, (2) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Myofascial therapy  physiotherapist positioned laterally to the participant, with their forearms crossed, caudal hand on the ilium, and cephalad hand on the posterior/inferior thorax, as described by Wong et al. The cephalad hand was sometimes moved towards the center or the contralateral thorax depending on the perceived tension. Gentle pressure was applied in order to target the TLF and erector spinae muscles. The therapist then applied tension between her hands in the different planes, according to the perceived tension, until reaching a restrictive barrier. The tension was maintained until an initial release was perceived; then, the therapist adjusted the tension applied on the tissue until reaching a new restrictive barrier. The technique was performed for four minutes on each side, starting on the left. for total of 8 minutes duration 
Comparator Agent  Sham myofascial release  The sham myofascial group will have a release performed in the same way as the interventional group but with superficial contact and no tension applied between the hands.it was applied for four minutes either side.for total of 8 minutes duration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients having pain localized between the 12th rib and the gluteal fold for more than three months;
 
 
ExclusionCriteria 
Details  had a history of serious spinal or lower-extremity
injury or a history of surgery in the past year;

received manual therapy applied to the lumbosacral region in the month preceding
the intervention and during the course of the study.

 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Thickness of bilateral thoracolumbar fascia
2)stiffness of bilateral erector spinae
3)stiffness of bilateral thoracolumbar fascia 		 pre intervention(t0) and post intervention(t1) 
 
Secondary Outcome  
Outcome  TimePoints 
lumbar flexibility
 		 pre intervention(t0) and post intervention(t1) 
pain quality
 		 pre intervention(t0) and post intervention(t1) 
physical function  pre intervention(t0) and post intervention(t1) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   18/02/2025 
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="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [t0223004@sriher.edu.in].

  6. For how long will this data be available start date provided 01-02-2025 and end date provided 01-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The current study will be performed after the approval of the Ethical Committee
 Informed consent will be obtained from each subject included in this study. All patients will be subjected to the following:

A clinical data will be collected, including body mass index and duration of Low back pain.

 The participants will be randomly assigned to one of the two groups. The assessments of tissue stiffness and thickness will be performed by a Musculoskeletal Ultrasonography consultant .
 The subjects will be then asked to adopt a prone position with their head in a neutral position and the L2 and L3 interspinous space was localized by manual palpation by a musculoskeletal ultra sonographer and evaluates the thoracolumbar fascia thickness. The probe will be then placed 2 cm lateral to this mark on the right and left sides to evaluate the stiffness of erector spinae.
After these measurements a physiotherapist applies either the Myofascial therapy or the simulated Myofascial therapy according to group allocation. The myofascial therapy group undergoes an initial Superficial myofascial release for warming up by deep sliding across the back followed by deep myofascial release techniques. The simulated group undergoes a sham myofascial release there with superficial gliding.
 the post-treatment assessment  comprising the sonoelastographic evaluation on stiffness of erector spinae and thoracolumbar fascia and thickness of thoracolumbar fascia using B mode ultrasound will be evaluated. Pain measurements and trunk flexibility  and physical function will be performed before treatment  and  after treatment .
 
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