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CTRI Number  CTRI/2025/03/083656 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 15/02/2026
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   Testing the effectiveness of a specific shoulder exercise in Rotator Cuff Related Shoulder Pain 
Scientific Title of Study   Effectiveness of shoulder external rotator isometric exercise in Rotator Cuff Related Shoulder Pain: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aiswarya C K  
Designation  Post graduate 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9645423812  
Fax    
Email  ckaiswarya123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Saumya srivastava 
Designation  Associate professor 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740244077  
Fax    
Email  saumyasri2000@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Saumya srivastava 
Designation  Associate professor 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740244077  
Fax    
Email  saumyasri2000@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of physiotherapy room number 20,second base division and department of orthopaedics third floor ,Justice K S Hegde hospital,Medical science complex,Deralakatte,Mangalore,575018,Dakshina kaanada,Karnataka 
 
Primary Sponsor  
Name  Justice K S Hegde charitable hospital 
Address  Department of physiotherapy room number 20,second base division and department of orthopaedics third floor ,Justice K S Hegde hospital,Medical science complex,Deralakatte,Mangalore,575018,Dakshina kaanada,Karnataka 
Type of Sponsor  Research institution 
 
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 
Dr SAUMYA SRIVASTAVA  Justice K S Hegde hospital  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru.
Dakshina Kannada
KARNATAKA 		 9740244077

saumyasri2000@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE ,NITTE DEEMED TO BE UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General shoulder exercise  Group B- General shoulder exercise only ,which includes active range of motion of flexion and abduction, cross body horizontal adduction stretch, scapular retraction using Thera band. total duration - 45 minutes/session,2 sessions/week for 4 weeks 
Intervention  Shoulder external rotator isometric exercise + General shoulder exercise  Group A- shoulder external rotator isometric exercise in 0,45,90 degree using Thera band and general shoulder exercise-which includes active range of motion of flexion and abduction, cross body horizontal adduction stretch, scapular retraction using Thera band total duration-45 minutes/sessions,2 sessions/week for 4 weeks  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Presence of a positive result for at least three of the following criteria: the Neer impingement test, the Hawkins Kennedy impingement test, the empty can test, pain with resisted external rotation, palpable tenderness at the insertion of the supraspinatus or infraspinatus, or painful arc from 60° to 120° during active abduction.

No ROM loss greater than 25% in at least 2 planes of motion and no passive external rotation loss greater than 50% of the uninvolved shoulder.
 
 
ExclusionCriteria 
Details  Full thickness supraspinatus or infraspinatus tendon tears confirmed by MRI or CT scan.
Adhesive capsulitis as identified by multiple plane passive motion loss.
Cervical radiculopathy.
History of bony trauma (fracture, dislocation) to the shoulder joint.
Previous shoulder surgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Western Ontario Rotator Cuff Index  Baseline and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Numerical pain rating scale, Isometric strength value for shoulder external rotator using Hand Held Dynamometer,Active range of motion of shoulder using goniometer.  Baseline & 4 weeks 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/04/2025 
Date of Study Completion (India) 02/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 02/01/2026 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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  
Rotator Cuff Related Shoulder Pain (RCRSP) affects 15-30 % of population, Despite various treatment approaches ,no significant differences have been observed in pain reduction ,improvement in range of motion and quality of life .Knowledge gaps exist in targeted rehabilitation strategies ,isometric exercise for shoulder external rotators. Participants will be recruited from Justice K S Hegde charitable hospital who experience shoulder pain with consideration of eligibility criteria, further, participants (34) will be categorized in to group A(shoulder external rotator isometric exercise and general shoulder exercise) and group B ( general shoulder exercise) using SNOSE method. Assessed on the basis of Western Ontario Rotator Cuff index for quality of life, Numerical pain rating scale for pain, Hand Held Dynamometer for isometric strength, Goniometer for active range of motion of shoulder. Treatment duration is 2 sessions per week for 4 weeks, each lasting 45 minutes. After 4 weeks participants will undergo re assessment using the same outcome measures. Primary hypothesis is that the shoulder external rotator isometric exercise will be superior to general exercise in reducing pain, improving isometric strength, Range of motion and quality of life in patients with RCRSP.
 
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