| CTRI Number |
CTRI/2024/08/072815 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Punjabi Translation of Western Ontario Rotator Cuff Index (WORC) questionnaire |
|
Scientific Title of Study
|
Translation, cross-cultural adaptation, validation and reliability of Western Ontario Rotator Cuff index in Punjabi language |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navneet Kaur Aulakh |
| Designation |
MPT student |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University), Mullana |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana, India.
Ambala
HARYANA
133203
India |
| Phone |
7626946090 |
| Fax |
|
| Email |
navneetaulakh1820@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simranjeet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University), Mullana |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana, India.
Ambala
HARYANA
133203
India |
| Phone |
9877144498 |
| Fax |
|
| Email |
dr.simranjeet.kaur@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Navneet Kaur Aulakh |
| Designation |
MPT student |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University), Mullana |
| Address |
Room No.3, Musculoskeletal OPD, Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana, India.
Ambala
HARYANA
133203
India |
| Phone |
07626946090 |
| Fax |
|
| Email |
navneetaulakh1820@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 3, Musculoskeletal OPD of Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mallana
Haryana
India
pin code:133207 |
|
|
Primary Sponsor
|
| Name |
Navneet Kaur Aulakh |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala, Haryana, India
Pin Code: 133207. |
| Type of Sponsor |
Other [] |
|
|
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 |
| Navneet Kaur |
Room No. 3, Musculoskeletal OPD, Maharishi Markandeshwar (Deemed to be University) Mullana |
MAHARISHI MARKANDESWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MAHARISHI MARKANDESWAR DEEMED TO BE UNIVERSITY, MULLANA, AMBALA, HARYANA
India
Pin code:133207
Ambala
HARYANA |
7626946090
navneetaulakh1820@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Science and Research, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Impingement syndrome, partial or full-thickness rotator cuff tears.
2. The diagnosis was confirmed in each patient by history, physical examination, and appropriate radiological evaluations. |
|
| ExclusionCriteria |
| Details |
1.Patients with history of fracture, acute and chronic inflammatory diseases and patients with impairments in the cervical spine, elbow, or hand affecting the shoulder function.
2.Patients with cognitive, neurological disorders, rheumatic disorders, or other shoulder diseases. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Western Ontario Rotator cuff index (WORC)
|
Western Ontario Rotator cuff index (WORC) baseline 72 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disabilities of the Arm, shoulder, & Hand (DASH) |
Disabilities of the Arm, shoulder, & Hand (DASH) baseline 72 hours |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
31/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
The use of the Western Ontario Rotator Cuff Index to assess effectiveness of physical therapy on rotator cuff injuries: A systematic review |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
I am working on the translation of WORC into Punjabi language. For this permission was taken from the developer of WORC. Steps that were taken for translation of the scale were: preparation of draft, forward translation (original WORC into Punjabi language), compilation of drafts (all the corrections and modifications that were suggested was compiled), backward translation (translated draft into English for the language verification). This process obtains a pre final draft. Content validation is done by Delphi method. After receiving the CTRI no. patients will be recruited for the cross-culture adaptation and reliability. 30 patients will be recruited for cross-cultural adaptation. 51 patients for reliability will be taken. |