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CTRI Number  CTRI/2021/12/038593 [Registered on: 13/12/2021] Trial Registered Prospectively
Last Modified On: 15/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   To compare the effect of muscle energy technique and modified cross-body stretching in individuals with posterior capsule tightness of shoulder  
Scientific Title of Study   Comparison between muscle energy technique and modified cross-body stretching in individuals with posterior shoulder capsule tightness : A randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhishek Shetty k 
Designation  Master of Physiotherapy(MPT) Student 
Affiliation  Nitte Institute of Physiotherapy 
Address  Nitte Institute of Physiotherapy,Nitte Deemed to be University,Nithyananda Nagar,Derlakatte,Mangalore Dakshina Kannada

Dakshina Kannada
KARNATAKA
575018
India 
Phone  6362838702  
Fax    
Email  Abhishek.20ptms01@student.nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Saumya Srivastava 
Designation  Assistant Professor 
Affiliation  Nitte Institute of Physiotherapy 
Address  Nitte Institute of Physiotherapy,Nitte Deemed to be University,Nithyananda Nagar,Derlakatte,Mangalore Dakshina Kannada

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740244077  
Fax    
Email  saumyasri2000@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Abhishek Shetty k 
Designation  Master of Physiotherapy(MPT) Student 
Affiliation  Nitte Institute of Physiotherapy 
Address  Nitte Institute of Physiotherapy,Nitte Deemed to be University,Nithyananda Nagar,Derlakatte,Mangalore Dakshina Kannada

Dakshina Kannada
KARNATAKA
575018
India 
Phone  6362838702  
Fax    
Email  Abhishek.20ptms01@student.nitte.edu.in  
 
Source of Monetary or Material Support  
Nitte Institute of Physiotherapy, Nitte Deemed to be University,NithyanandaNagar,Derlakatte,Mangalore, Karnataka,India 575018 
 
Primary Sponsor  
Name  Nitte Deemed to be University 
Address  Nitte Institute of Physiotherapy,Nitte Deemed to be University,Nithyananda Nagar,Derlakatte,Mangalore 
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 
Abhishek Shetty k  Justice K S Hegde Charitable Hospital, Manglore  Ground floor room No.20.Department of Physiotherapy, K S Hegde Medical Sciences Complexes, Mitte Deemed to be University, Deralakatte, Mangalore, Dakshina Kannada, KARNATAKA
Dakshina Kannada
KARNATAKA 		 6362838702

Abhishek.20ptms01@student.nitte.edu.in 
 
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 
Healthy Human Volunteers  Posterior shoulder capsule tightness 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Modified cross-body stretching  The participants of this group will be given modified cross body stretching. Position of the subject : The subject will be in side lying position. Position of therapist: standing by the side/behind of the subject.The subject will be in sitting position. Subjects will be demonstrated how to perform the exercise. The modified cross body stretch will be performed by asking them to passively pull the humerus across the body into horizontal adduction with the opposite arm in while lying down in side lying position. Participants will be asked to perform the stretch at a mild discomfort once daily for 5 repetitions, and holding the stretch for about 30 seconds for 2 days in a week over 4 week period.  
Intervention  Muscle energy technique stretching procedure  The participants of this group will be given muscle energy technique. Post Isometric Relaxation type of MET will be given. Position of the subject : The subject will be in supine position. Position of therapist: standing by the side of the subject. Muscle energy technique stretching procedure: The subject will be in supine position. Subjects will be demonstrated how to the exercise will be performed. The examiner stabilizes the scapula at lateral border and with the elbow flexed the participant’s shoulder will be horizontally adducted. The participant will be asked to perform a 5 second isometric contraction at approximately 25% maximal effort in the direction of horizontal abduction, against an opposing force produced by the examiner at the distal humerus. Following the contraction the participant will be instructed to to pull the arm across the body, as the examiner will apply a 30 second active assisted stretch. The participant will be told to relax. This protocol will be performed for 3 repetitions per treatment session., 2 times a week for 4 weeks  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  1. Subjects with glenohumeral internal rotation deficit > 10 degrees. 
 
ExclusionCriteria 
Details  1. Subjects with shoulder pain and related symptoms.
2. History of shoulder injury.
3. History of shoulder dislocation.
4. Individuals who are indulged regularly in pilates, yoga or going to gym.
5. Athletes.
6. Full thickness rotator cuff tear.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Universal goniometer
2. Thumb-up-the-back test

 		 4 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/12/2021 
Date of Study Completion (India) 08/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Muscle energy technique and modified cross-body stretching have been found to be efective in treating posterior shoulder capsule tightness but they haven not been compared between each other. The aim of this study is to do a comparison between the interventions and to determine the most effective treatment among the two. 
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