| 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
|
|
|
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
|
|
|
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
|
|
|
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. |