| CTRI Number |
CTRI/2024/07/070856 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| 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
|
Effects of shoulder strengthening exercise and taping on scapular position hand grip quality of life among shoulder impingement |
|
Scientific Title of Study
|
Effects of shoulder eccentric strengthening exercise versus dynamic taping on scapular position, hand grip and quality of life among sub-acromial impingement syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siva Anandhi R |
| Designation |
Assistant Professor and Research scholar |
| Affiliation |
Vels Institute of Science and Technology and Advanced Studies (VISTAS) |
| Address |
ROOM NO PHY214 School of Physiotherapy Department of Orthopedics Physiotherapy Vels Institute of Science and Technology and Advanced Studies (VISTAS)Thalambur Division Chennai
Chennai
TAMIL NADU
600130
India |
| Phone |
09841308099 |
| Fax |
|
| Email |
sivaphysio271993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Senthil Selvam |
| Designation |
Professor and Head of Department |
| Affiliation |
Vels Institute of Science and Technology and Advanced Studies (VISTAS) |
| Address |
ROOM NO PHY214 School of Physiotherapy Department of Orthopedic Physiotherapy Vels Institute of Science and Technology and Advanced Studies (VISTAS) Thalambur Division Chennai
Chennai
TAMIL NADU
600130
India |
| Phone |
9444309160 |
| Fax |
|
| Email |
hodphysiotherapy@velsuniv.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Siva Anandhi R |
| Designation |
Assistant Professor and Research Scholar |
| Affiliation |
Vels Institute of Science and Technology and Advanced Studies (VISTAS) |
| Address |
ROOM NO PHY214 School of Physiotherapy Department of Orthopedic Physiotherapy Vels Institute of Science and Technology and Advanced Studies (VISTAS) Thalambur Division Chennai
Chennai
TAMIL NADU
600130
India |
| Phone |
09841308099 |
| Fax |
|
| Email |
sivaphysio271993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Isari Velan mission Hospital |
|
|
Primary Sponsor
|
| Name |
Siva Anandhi R |
| Address |
ROOM NO PHY214 School of Physiotherapy Department of Orthopedics Physiotherapy Vels Institute of Science and Technology and Advanced Studies (VISTAS) Thalambur Division Chennai-600130 India |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shiden Kumar TK |
Shri Ishri velan mission hospital |
OPD Room Ground Floor Thalambur Chennai-600130
Chennai
TAMIL NADU |
07306371288
dr.shidenkumartk@gmail.com |
| Ms Siva Anandhi R |
Shri Ishri velan mission hospital |
Room NO PHY214 School of Physiotherapy Deparment of Orthopedic Physiotherapy Thalambur Division Chennai-600130
Chennai
TAMIL NADU |
9841308099
sivaphysio271993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Department Ethical Commitee |
Approved |
| VISTAS-SPS-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M754||Impingement syndrome of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dynamic scapular stabilisation exercise |
Each exercise was done for 3 sets of 10 repetition -3 times a week for 6 weeks |
| Intervention |
Dynamic Taping |
The tape was applied and replaced every 3 days for 6 weeks |
| Intervention |
Eccentric strengthening Exercise |
Each exercise done for 3 sets of 10 repetition-3 times a week for 6 weeks
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Mechanical exposure workers(Construction workers)
Type 1 and Type 2 sub-acromial impingement
Three positive indications of the following tests:
Tenderness on palpation of the supraspinatus or infraspinatus tendon insertion
Painful arc between 60 degree to 120 degree of abduction
Neer impingement sign
Hawkins Kennedy test
Jobe’s supraspinatus test
|
|
| ExclusionCriteria |
| Details |
Subject with a history of shoulder surgery
Adhesive capsulitis
Diagnostic instability or previous history of dislocation
Systemic inflammatory conditions like rheumatoid arthritis
Restricted ROM has been seen in burns or postoperative scars.
Neurological deficits like multiple sclerosis
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand grip strength |
6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SCAPULAR POSITION |
6 WEEKS |
| QUALITY OF LIFE |
6 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/07/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is a randomized, parallel-group trial comparing the Effects of Shoulder Eccentric Strengthening Exercise versus Dynamic Taping for 6 weeks in 69 patients with sub-acromial impingement patients that will be in the Shri Ishari Velan Mission Hospital, Chennai. The primary outcome of this study is to measure will affect hand grip strength. The secondary outcome measures will be and quality of life among sub-acromial impingement patients for 6 weeks |