| CTRI Number |
CTRI/2024/05/067478 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| 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
|
Comparing the effects of various techniques like proprioceptive neuromuscular facilitation with mulligan versus muscle energy technique With mulligan to enhance glenohumeral internal rotation deficit in college going athletes involved in overhead sports |
|
Scientific Title of Study
|
To compare the effects of proprioceptive neuromuscular facilitation with mulligan versus muscle energy technique with mulligan to improve glenohumeral internal rotation deficit in collegiate athletes playing overhead sports- an experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Bhatt |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Room No-04, Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
Dehradun UTTARANCHAL 248001 India |
| Phone |
7456907715 |
| Fax |
|
| Email |
bhattjyoti014@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shama Praveen |
| Designation |
Assistant Professor |
| Affiliation |
Shri Mahant Indresh Hospital, Patel Nagar, Dehradun |
| Address |
Room No-04, Department of Physiotherapy, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
Dehradun UTTARANCHAL 248001 India |
| Phone |
8006965111 |
| Fax |
|
| Email |
shamapraveen@sgrrmc.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shama Praveen |
| Designation |
Assistant Professor |
| Affiliation |
Shri Mahant Indresh Hospital, Patel Nagar, Dehradun |
| Address |
Room No-04, Department of Physiotherapy, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
Dehradun UTTARANCHAL 248001 India |
| Phone |
8006965111 |
| Fax |
|
| Email |
shamapraveen@sgrrmc.com |
|
|
Source of Monetary or Material Support
|
| Shri Mahant Indresh Hospital, Patel Nagar, Dehradun |
|
|
Primary Sponsor
|
| Name |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Department of Physiotherapy North Block, Lower Ground Shri Mahant Indresh Hospital Patel Nagar Dehradun |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyoti Bhatt PT |
Shri Mahant Indresh Hospital |
Department of physiotherapy, North Block, Lower Ground, Patel Nagar, dehradun Dehradun UTTARANCHAL |
7456907715
bhattjyoti014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Muscle energy technique with mulligan |
The Mulligan intervention will be same as above.
For Muscle Energy Technique, the subject will be placed in a supine posture with their elbow and shoulder in a 90-degree abduction and flexion position. Internal rotation will be applied to the humerus until the first resistance is reached. The next step for the subject is to execute a 5-second isometric contraction against a certain opposing force in the direction of external rotation at about 25% of peak effort. There will be a 30-second active assisted stretch for the external rotators. Subjects will be encouraged to relax and a new movement barrier will be engaged.
Repetitions and Duration- 3 repetitions and 1 set with 5 sec isometric contraction followed by 30 second stretch for 5 days a week for 4 weeks.
|
| Intervention |
Proprioceptive neuromuscular facilitation With mulligan |
The Mulligan technique will involve placing the subject supine with their elbow and shoulder flexed at 90 degrees. A mobilizing belt will be secured around the therapists waist perpendicular to the humerus, and both hands will grab the distal humerus. The joint will be laterally distracted while pushing back the belt. The patient will voluntarily internally rotate their shoulder while the belt maintains lateral distraction.
Repetitions and Duration- 4 to 5 repetitions and 1 set with 10 sec hold. 5 sessions a week for 4 weeks
Three proprioceptive neuromuscular facilitation stretches will be employed: the sleeper, cross body, and genie. Subjects will be passively stretched to their endpoint for 7 seconds with the scapula stabilized. Then, they will be asked to contract against the resistance for 3 seconds, followed by another passive resistance to a new endpoint.
Repetitions and Duration- 3 iterations and 1 set with first 7 seconds stretch at the end point then 3 sec hold against the resistance. . 5 sessions a week for 4 weeks
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-30 years Athletes playing Overhead Sports.
2. Athletes playing Cricket, Basketball, Baseball, Tennis, Badminton, Javelin, Discuss Throw, Shot put
3. Both Females and Males
4. Subjects who are willing to participate in the study.
5. Posterior Capsular Tightness (assessed by Tyler Test)
|
|
| ExclusionCriteria |
| Details |
1. Numbness or tingling in upper extremity
2. Previous shoulder or neck surgery
3. Shoulder conditions like adhesive capsulitis, labral tear, shoulder instability
4. Cervical or spine pathologies.
|
|
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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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand-behind-back (HBB) |
Baseline Data
4th week data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tyler Test |
Baseline Data
4th week data |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
25/06/2024 |
| 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="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study aims to compare the effects of two treatment protocols, Proprioceptive Neuromuscular Facilitation (PNF) with Mulligan and Muscle Energy Technique (MET) with Mulligan, on Glenohumeral Internal Rotation Deficit (GIRD) in Collegiate Athletes participating in Overhead Sports. The objectives include assessing the efficacy of each technique individually and determining which protocol yields faster results. The study proposes an alternate hypothesis suggesting a significant difference in the effects of the two techniques, while the null hypothesis indicates no significant difference. |