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CTRI Number  CTRI/2026/01/100598 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of myofascial release therapy on shoulder posture and mobility in individuals with tetraplegia 
Scientific Title of Study   Effect of myofascial release on shoulder posture and range of motion in individuals with tetraplegia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepanshi Singh 
Designation  Postgraduate Student (Masters of Physiotherapy) 
Affiliation  ISIC - Institute of Rehabilitation Sciences 
Address  ISIC - Institute of Rehabilitation Sciences, Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070

South
DELHI
110070
India 
Phone  8471007881  
Fax    
Email  deepanshisingh198@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Megha Nijhawan  
Designation  Associate Professor  
Affiliation  ISIC - Institute of Rehabilitation Sciences 
Address  ISIC - Institute of Rehabilitation Sciences, Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070

South
DELHI
110070
India 
Phone  8802021752  
Fax    
Email  physiomegha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepanshi Singh 
Designation  Postgraduate Student (Masters of Physiotherapy) 
Affiliation  ISIC - Institute of Rehabilitation Sciences 
Address  ISIC - Institute of Rehabilitation Sciences, Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070

South
DELHI
110070
India 
Phone  8471007881  
Fax    
Email  deepanshisingh198@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Indian Spinal Injuries Centre 
Address  Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070 
Type of Sponsor  Research institution and hospital 
 
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 
Deepanshi Singh  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences  ISIC - Institute of Rehabilitation Sciences, Opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South
DELHI 
8471007881

deepanshisingh198@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G825||Quadriplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Control Group will receive sham (inactive) myofascial release along with conventional physical therapy (stretching and strengthening exercises of shoulder muscles). Duration of each session will be about 40 minutes. 5 times a week for 2 weeks. 
Intervention  Myofascial Release Group  Myofascial Release Group will receive myofascial release technique along with conventional physical therapy (stretching and strengthening exercises of shoulder muscles). Duration of each session will be about 40 minutes. 5 times a week for 2 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18-60 years

Diagnosed SCI (traumatic and non traumatic) classified as A, B, C, D on the ASIA Impairment Scale, Level of Injury – C5-C8, 3 months post injury

Observable rounded shoulder posture

Anterior chest tightness assessed through pectorals muscle length testing

Patient willing to participate and medically stable to undergo manual therapy sessions. 
 
ExclusionCriteria 
Details  Individuals with cervical SCI diagnosed with or have history of any – Shoulder surgeries, injury and conditions like instability, upper limb fractures, adhesive capsulitis, rotator cuff tear

Contraindications to MFR -
Acute inflammation, cellulitis, deep vein thrombosis, hematoma, malignancy, osteomyelitis, rheumatoid arthritis, oedema, skin sensitivity.

Any cognitive and psychiatric impairments or conditions affecting communication or compliance. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Rounded Shoulder Angle
Passive Range of Motion 
Baseline Assessment (Week 0)
Post Intervention (Week 2) 
 
Secondary Outcome  
Outcome  TimePoints 
Shoulder Function  Baseline Assessment (Week 0)
Post Intervention (Week 2) 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   17/01/2026 
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="4"
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  

1.     BACKGROUND:

Individuals with cervical spinal cord injury (SCI) depend on their upper limbs for mobility, making them highly prevalent to shoulder pain and dysfunction. It arises from altered biomechanics due to wheelchair propulsion, muscle imbalance, and postural changes, often resulting in rounded shoulder posture (RSP) and soft tissue restrictions.

A major factor to shoulder pain and postural dysfunction is pectoralis fascia and muscles tightness. The myofascial release (MFR) has been shown to reduce fascial restrictions, improve posture, range of motion (ROM), function and spasticity in neurological conditions like stroke, multiple sclerosis and cerebral palsy.

The role of MFR in individuals with tetraplegia in improving rounded shoulder posture, anterior chest tightness and ROM is underexplored. The results of the present study will help in formulating a comprehensive physiotherapy plan for shoulder range and rounded shoulder posture in individuals with tetraplegia.

2. OBJECTIVES

·       To find out the effect of myofascial release on Posture (Rounded/Forward Shoulder Angle) in individuals with tetraplegia

·       To evaluate the effect of myofascial release on Function (Shoulder Pain and Disability Index) in individuals with tetraplegia

·       To evaluate the effect of myofascial release on Passive Range of Motion (Universal Goniometer) in individuals with tetraplegia

 3. HYPOTHESIS

Null Hypothesis Ho-

•        There is no significant difference in effect of myofascial release (MFR) combined with conventional physiotherapy versus sham MFR combined with conventional physiotherapy on posture, function and PROM in individuals with tetraplegia.

Alternate Hypothesis H1-

•        There is a significant difference in effect of MFR combined with conventional physiotherapy versus sham MFR combined with conventional physiotherapy on posture, function and PROM in individuals with tetraplegia.

4. MATERIAL AND METHODS

This randomized controlled trial will be conducted on tetraplegic patients with rounded shoulder posture and restricted range of motion of shoulder, recruited from the Indian Spinal Injury Centre, New Delhi. A total of 20 participants (10 in each group) will be included based on strict inclusion and exclusion criteria. Eligible individuals will be aged 18–60 years, diagnosed with paraplegia (C5–C8) level. Participants with history of trauma or surgery, diagnosed with inflammatory disorders, adhesive capsulitis and joint instability, analgesic use, or cognitive issues will be excluded.

Baseline assessments will cover posture (Rounded/Forward Shoulder Angle measured via photography using MB-Ruler-freeware for screen-based angle and distance measurement), functional limitation (Shoulder Pain and Disability Index-SPADI) and PROM (goniometry). Participants will be randomly assigned into a control group (sham MFR + conventional physical therapy) and an experimental group (MFR + conventional therapy). The intervention will be conducted for 40 minutes per session, five times a week for two weeks. Post-intervention assessments will follow the same outcome measures.

5.  STATISTICAL ANALYSIS PLAN:

Data will be analysed using SPSS v21.0. Normality will be tested with the Shapiro-Wilk test. Paired t-test or Wilcoxon test will be used for within-group comparisons, and independent t-test or Mann–Whitney U test for between-group comparisons.

 
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