FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/01/030821 [Registered on: 28/01/2021] Trial Registered Prospectively
Last Modified On: 27/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Effect of rotator cuff pathology on ratio of glenohumeral motion to scapulothoracic motion in arm elevation. 
Scientific Title of Study   Effect of rotator cuff pathology on scapulohumeral rhythm in arm elevation.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhavana mhatre 
Designation  Professor 
Affiliation  PT School and Centre, Seth GS Medical College and KEM Hospital 
Address  402,Ground floor,PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  28bhavanamhatre@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bhavana mhatre 
Designation  Professor 
Affiliation  PT School and Centre, Seth GS Medical College and KEM Hospital 
Address  402,Ground floor, PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  28bhavanamhatre@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vibhawari Wagh 
Designation  Post graduate student (MPT) 
Affiliation  PT School and Centre, Seth GS Medical College and KEM Hospital 
Address  402,Ground floor, PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  vibhawariwagh96@gmail.com  
 
Source of Monetary or Material Support  
PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East, Mumbai 400012 
 
Primary Sponsor  
Name  Bhvana Mhatre 
Address  PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East, Mumbai 400012 
Type of Sponsor  Other [Self] 
 
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 
Bhavana Mhatre  PT School and Centre, Seth G S Medical College and KEM Hospital  PT School and Centre, Seth G S Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East, Mumbai 400012
Mumbai
MAHARASHTRA 
02224143435

28bhavanamhatre@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)-II, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Rotator cuff pathology patients:
1.partial tear of rotator cuff
2.rotator cuff tendinitis
3.rotator cuff tendinosis
Both conservatively and operated patients for rotator cuff pathology
Patients with medically diagnosed as rotator cuff pathology
Any three positive test from followiong:
1.lift off test/belly press test
2.bear hug test
3.Jobe’s test
4.hornblowers sign.


 
 
ExclusionCriteria 
Details  Patients with :
1.Bicipital tendinitis – positive speeds test
2.Bursitis
3.Complete rotator cuff muscle tear: positive drop arm test
4.Fractures at scapula ,clavicle , humerus
5.Shoulder dislocations
6.Any infective, inflammatory and neoplastic condition of shoulder.
7.Vascular conditions
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Scapulohumeral rhythm ratio  once, at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   01/02/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Rotator cuff is a group of muscles and there tendons that act to stabilize glenohumeral  joint and allow for its extensive range of motion. Rotator cuff muscles comprises of supraspinatus ,infraspinatus, teres minor, subscapularis. Rotator cuff pathology includes rotator cuff muscle tear, rotator cuff tendinitis, rotator cuff tendinosis. Prevalence of rotator cuff pathology is 18% in manual labours and is also prevalent in young sport person as well as those in middle and older age.

Optimal function of the shoulder during arm elevation is synchronous and coordinated movement of scapula and humerus. Specifically, the kinematic interaction between the scapula and the humerus was introduced in the 1930s and termed "scapulohumeral rhythm. In the literature Scapulohumeral rhythm is descibed like a ratio: humeral elevation: scapular upward rotation. The overall ratio of 2:1 during arm elevation is commonly used. As the shoulder complex mechanism include scapulothoracic motion and glenohumeral motion during arm elevation. Pathology of rotator cuff muscles will bring mobility deficit in glenohumeral range due to poor muscle performance & control and strength deficits. If the scapulothoracic  mechanism is altered then it should be included in the treatment plan while tackling rotator cuff pathology.Therefore assessment of scapulothoracic mechanism is essential to address glenohumeral pathology.

In this study scapulothoracic rhythm is assesd with two inclinometer which will measure glenohumeral elevation and scapular upward rotation. And scapulohumeral ratio will be calculates by taking ratio. This is a observational cross sectional type of study which requires 20 mins per participant. Data will be analysed using upaired T test.

 

 
Close