| CTRI Number |
CTRI/2023/01/048841 [Registered on: 09/01/2023] Trial Registered Prospectively |
| Last Modified On: |
06/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation between Scapula motion, Shoulder joint position sense and function in patients with Rotator cuff tear |
|
Scientific Title of Study
|
Correlation of Scapula Dyskinesis and Joint position sense with perception towards function in subjects with Rotator Cuff tear |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipti Geete |
| Designation |
Assistant Professor |
| Affiliation |
P.T. School and centre, Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre, Seth GS Medical college and KEM hospital,Acharya Dhonde Marg, Parel (E),Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
dipti_geete@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dipti Geete |
| Designation |
Assistant Professor |
| Affiliation |
P.T. School and centre, Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre, Seth GS Medical college and KEM hospital,Acharya Dhonde Marg, Parel (E),Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
dipti_geete@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Saniya Shaikh |
| Designation |
Master of Physiotherapy |
| Affiliation |
P.T. School and centre, Seth GS Medical college and KEM hospital |
| Address |
P.T.School and centre, Seth GS Medical college and KEM hospital,Acharya Dhonde Marg, Parel (E),Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
drsaniya.ss@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.T. School and Centre, Seth GS Medical College and KEM Hospital, Parel(E), Mumbai-12 |
|
|
Primary Sponsor
|
| Name |
Dipti Geete |
| Address |
P.T. School and centre, Seth GS Medical college and KEM hospital, Parel(E), Mumbai-12 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dipti Geete |
P.T. School and centre, Seth GS Medical college and KEM hospital |
Room 5 , Physiotherapy OPD no 402,Parel (E),KEM hospital,Acharya Dhonde Marg,Parel(E),Mumbai-12
Mumbai
MAHARASHTRA |
02224143435
dipti_geete@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Seth GS Medical College and KEM Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with unilateral rotator cuff tear Grade 1&2 diagnosed on MRI |
|
| ExclusionCriteria |
| Details |
1.Massive rotator cuff tear
2.Fractures around shoulder joint
3.Acute RC tear
4.Any other upper extremity dysfunction 5.Neurological impairment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Active joint reposition test
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
12/01/2023 |
| 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 tendinopathy constitutes a major part of shoulder joint pathology. Minagawa et al (2013) found the prevalence of rotator cuff tears in the general population to be 22.1% In a recent cross-sectional study by Yamamoto et al, the authors found poor posture as an independent predictor of symptomatic and asymptomatic RC tears. With changing time, we see a drastic shift toward a sedentary lifestyle as more and more people assume poor postures for long periods leading to abnormal muscle activations and changes in kinematics. Changes in scapula kinematics alter the kinematics of the shoulder complex as a whole which further incites rotator cuff injuries. Scapula dyskinesis has been assessed previously after SLAP lesions, Bankart repair, and in subacromial impingement syndromes. A study by Stefano Gumina et al (2019) concluded that RCT provokes alterations in shoulder proprioception, evaluated as loss of joint position sense. Proprioception sense is essential to perform our daily activities. As the shoulder is inherently mobile it depends on joint proprioception for stability and mobility. In RCT, as the continuity of the musculotendon unit is affected it becomes essential to assess joint proprioception and subsequently plan a rehab protocol for the same. We believe that patient’s perception of ability should be valued more than the therapeutic evaluation of function. To assess this perception, we have incorporated the used Disability of Shoulder, Arm and Hand (DASH) and Shoulder Pain and Disability Index (SPADI) as a reliable tool to assess function in rotator cuff injuries. In this study, we aim to find a correlation of scapula dyskinesis and joint position sense with perception towards function in subjects with rotator cuff tear. 62 subjects with unilateral rotator cuff tear will be included in this study. Participants will be recruited into the study according to the inclusion and exclusion criteria. Theses participants will be assessed for scapula dyskinesis using the lateral scapula slide test and the scapula dyskinesis test, for joint position sense using an inclinometer and performing active joint repositioning test. The data collected will be analysed according to the distribution of data using Pearson’s Correlation Test or Spearman’s Correlation Test. |