| 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 |
|
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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] |
|
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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 |
| 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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
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Intervention / Comparator Agent
|
|
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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
|
|
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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. |