| CTRI Number |
CTRI/2025/03/082081 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| 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
|
Effects of Post-Isometric Relaxation on Pain, Shoulder Alignment, and Function in Overhead Shoulder Injuries. |
|
Scientific Title of Study
|
Impact Of Post Isometric Relaxation On Pain, Glenohumeral joint positional fault and Functional ability in Overhead Shoulder Injury. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sim Tanwar |
| Designation |
Student |
| Affiliation |
SGT University |
| Address |
Department of faculty of Physiotherapy, SGT University Chandu budhera
Gurgaon
Haryana
122505
India
Gurgaon
HARYANA
122505
India |
| Phone |
9460023354 |
| Fax |
|
| Email |
simtanwar05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddhartha Sen |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Department of faculty of Physiotherapy, SGT University Chandu budhera
Gurgaon
Haryana
122505
India
Gurgaon
HARYANA
122505
India |
| Phone |
9412985124 |
| Fax |
|
| Email |
siddhartha_fphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddhartha Sen |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Department of faculty of Physiotherapy, SGT University Chandu budhera
Gurgaon
Haryana
122505
India
Gurgaon
HARYANA
122505
India |
| Phone |
9412985124 |
| Fax |
|
| Email |
siddhartha_fphy@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Faculty of physiotherapy,SGT UniversityChandu Budhera Village 122505 |
|
|
Primary Sponsor
|
| Name |
Sim Tanwar |
| Address |
Faculty of Physiotherapy SGT University Chandu Budhera Gurugram 122505 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Sim Tanwar |
SGT Hospital |
Room No-13, physiotherapy OPD, Budhera, Gurugram- 122505
Gurgaon
HARYANA |
9460023354
simtanwar05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethical Committee, Faculty of physiotherapy,SGT University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M751||Rotator cuff tear or rupture, notspecified as traumatic, (2) ICD-10 Condition: M754||Impingement syndrome of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 - Post isometric relaxation technique |
Patient will perform post isometric relaxation technique which include strengthening exercise for shoulder muscles.Each exercise will be performed 3 time a week for 4 week with 3 set of 10 repetation. |
| Comparator Agent |
Group 2 - Strengthening Exercise |
Normal stretching and strengthening of shoulder muscles.Each exercise will be performed 3 time a week for 4 week with 3 set of 10 repetation. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Age 17-35
2/5 impingement test to be positive (Neer’s impingement test, Hawkins – Kennedy test, positive abduction test, jobes test , Apprehension test )
Painfull arc between 60-120 degree
|
|
| ExclusionCriteria |
| Details |
History of surgery for affected shoulder
Fracture in and around shoulder
Neurological disorder leading to altered muscle activity
Systematic arthritis( Osteoarthritis ,Rheumatoid arthritis, malignancies)
Corticosteroids injections in the affected shoulder in preceding 6 weeks
Shoulder injuries such as Rotator cuff tear
Disorder of cervical spine
|
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Glenohumeral joint Positioning Fault
|
Day 1 assessment
4th week assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain
Functional Ability |
Day 1 assessment
4th week assessment |
|
|
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)
|
21/03/2025 |
| 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="1"
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
|
Shoulder injuries are a prevalent concern among athletes participating in overhead sports such as baseball, swimming, tennis, and volleyball. The repetitive high-velocity movements in these sports place significant stress on the glenohumeral joint, leading to conditions like subacromial impingement syndrome (SAIS) and rotator cuff (RTC) tendonitis. These injuries often stem from muscle imbalances, altered kinematics, and structural changes, which can impair performance and increase the risk of chronic dysfunction. One promising rehabilitation approach is Post Isometric Relaxation (PIR), a Muscle Energy Technique (MET) that utilizes autogenic inhibition to enhance muscle flexibility, restore joint positioning, and improve neuromuscular function. This study aims to investigate the effectiveness of PIR in alleviating pain, correcting glenohumeral joint positional faults, and enhancing functional abilities in overhead athletes, contributing to improved rehabilitation strategies for shoulder injuries.
Null Hypothesis H01 : There will be no significant effect of Post isometric relaxation on pain in patient with Overhead shoulder injury. H02 : There will be no significant effect of Post isometric relaxation on glenohumeral joint positional fault in patient with Overhead shoulder injury H03: There will be no significant effect of Post isometric relaxation on functional ability in patient with Overhead shoulder injury Alternate Hypothesis H11 :There will be significant effect of Post isometric relaxation on pain in patient with Overhead shoulder injury H12: There will be significant effect of Post isometric relaxation on glenohumeral joint positional fault in patient with Overhead shoulder injury H13: There will be significant effect of Post isometric relaxation on functional ability in patient with Overhead shoulder injury
|