| CTRI Number |
CTRI/2022/08/044913 [Registered on: 25/08/2022] Trial Registered Prospectively |
| Last Modified On: |
24/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Relative effects of shoulder stability exercises and conventional therapy on shoulder pain and hand grip strength among patients with shoulder impingement syndrome |
|
Scientific Title of Study
|
Relative effects of shoulder stability exercises and conventional therapy on shoulder pain, range of motion, functional status and hand grip strength among patients with shoulder impingement syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ssivakumar |
| Designation |
MPT |
| Affiliation |
KMCH COLLEGE OF PHYSIOTHERAPY |
| Address |
Head of the department,KMCH college of physiotherapy,coimbatore.
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9842274794 |
| Fax |
|
| Email |
sss1612kmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ssivakumar |
| Designation |
MPT |
| Affiliation |
KMCH COLLEGE OF PHYSIOTHERAPY |
| Address |
Head of the department,KMCH college of physiotherapy,coimbatore.
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9842274794 |
| Fax |
|
| Email |
sss1612kmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Moulirajs |
| Designation |
Post graduate student |
| Affiliation |
KMCH COLLEGE OF PHYSIOTHERAPY |
| Address |
Kmch college of physiotherapy,coimbatore.
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9976508802 |
| Fax |
|
| Email |
mouli2707@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MoulirajS |
| Address |
no16,6th street,coimbatore.641048. |
| Type of Sponsor |
Other [self sponser] |
|
|
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 |
| SIVAKUMAR |
KMCH HOSPITALS |
HEAD OF THE PMR DEPARTMENT
ORTHOPAEDICS
Coimbatore
TAMIL NADU |
9842274794
sss1612kmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCH ETHICS COMMITEE |
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 |
conventional therapy |
ultrasound
shoulder range of motion exercise
30-40mins per session for 2 days per week for 4 weeks |
| Intervention |
shoulder stability exercises |
30-40 mins/session for 2 days a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
25 to 40years of age
Both male and female
Unilateral involvement
Shoulder pain and disability index minimum level of 25%
Atleast three of following test positive:
Hawkins kennedy test
Neer test
Painful arc test
Empty can test
painful external rotation test
Limited shoulder range of motion |
|
| ExclusionCriteria |
| Details |
Previous shoulder injury
Positive spurling test
Traumatic shoulder dislocation
Periarthritis shoulder
Sub acromial bursitis
Rotator cuff injury
Rheumatoid arthritis
Myofacial pain syndrome
Shoulder instability in last three months
Implant surgery
Shoulder pain with active or passive cervical rom
Shoulder surgery in the last 12months on the involved side
Involvement with sensory or muscular deficit
Psychological or behavioral disorder
Unsuitable for electrotherapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shoulder pain
Range of motion
Functional status
Hand grip strength |
Shoulder pain-4weeks
Range of motion-4weeks
Functional status-4weeks
Hand grip strength-4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| functional status |
functional status-4weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/09/2022 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Further research is needed to improve understanding of the effectiveness of training in enhancing shoulder girdle stabilty and its influence on hand muscle strength in patients with shoulder pathology. The purpose of this study was to investigate the effects of shoulder stability exercises and conventional therapy on shoulder pain, range of motion, functional status and hand grip strength among patients with shoulder impingement syndrome. |