FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036252 [Registered on: 06/09/2021] Trial Registered Prospectively
Last Modified On: 08/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To evaluate Shoulder Joint Position Sense in subjects with Shoulder pain due to Rotator cuff pathologies 
Scientific Title of Study   Evaluation of Shoulder Proprioception in subjects of Rotator cuff tendinopathy with Shoulder pain - An Observational study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshita Bhole 
Designation  Masters of Physiotherapy student 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  1st floor, Sancheti Institute College of Physiotherapy, Musculoskeletal Physiotherapy Department,12 Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  9881470899  
Fax    
Email  h1bhole@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sona Kolke 
Designation  Associate Professor, Department of Musculoskeletal Physiotherapy 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  1st floor, Sancheti Institute College of Physiotherapy, Musculoskeletal Physiotherapy Department,12 Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  9371004121  
Fax    
Email  sona.sarma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harshita Bhole 
Designation  Masters of Physiotherapy student 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  1st floor, Sancheti Institute College of Physiotherapy, Musculoskeletal Physiotherapy Department,12 Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  9881470899  
Fax    
Email  h1bhole@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Institute College of Physiotherapy 
 
Primary Sponsor  
Name  Sancheti Institute College of Physiotherapy 
Address  Sancheti Institute College of Physiotherapy,12 Thube Park, Shivajinagar Pune 411005 
Type of Sponsor  Private medical college 
 
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 Harshita Bhole  Sancheti Hospital for Orthopaedics and Rehabiliatation  16,floor-1, Department of musculoskeletal physiotherapy, Shivajinagar,Pune
Pune
MAHARASHTRA 		 9881470899

h1bhole@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sancheti Institute for Orthopedics and Rehabilitation   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects of unilateral Rotator cuff tendinopathy with shoulder pain and shoulder flexion and abduction range greater than 100° Shoulder pain on Visual Analogue Scale greater than 4 and less than 9. Presence of painful arc.Sub-acute and chronic pain. 3 out of 5 following tests are positive:Jobe’s (empty can) test,Neer Impingement test,Speed’s test,Painful arc and Drop arm test
Subjects of both gender 
 
ExclusionCriteria 
Details  Traumatic injury to the shoulder
Presence of neurological condition or deficit: stroke,nerve injury,radiculopathy,
brachial plexus injury
Undergone shoulder surgery
Presence of lymph node pathology,tumour around the shoulder region
Person with cognitive dysfunction 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Shoulder pain on Visual Analogue Scale.
Shoulder Joint Position Sense of affected and unaffected shoulder. 		 Assessed at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/09/2021 
Date of Study Completion (India) Date Missing 
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
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Shoulder pain is one of the commonest musculoskeletal disorder. The shoulder pain can originate from structures such as rotator cuff and other soft tissues surrounding the joint. Rotator cuff tendinopathy is one of the commonest causes of shoulder pain. It includes rotator cuff strains, rotator cuff tendonitis, tenosynovitis, rotator cuff impingement and partial tears (less than 50%). Proprioception is the ability to sense the position of the joint and limbs in relation to our body and the surrounding environment. Joint position sense is one of its component. The evidence of overall impact of pain on Joint Position Sense in subjects of Rotator cuff tendinopathy is less clear with limited studies on Indian population and hence more studies are necessary. This is an Observational study that will evaluate shoulder Joint position sense in subjects of Rotator cuff tendinopathy with shoulder pain and comparison will be done between the involved and uninvolved shoulder joint.   
Close