| CTRI Number |
CTRI/2024/08/072264 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Test-retest design |
| Study Design |
Other |
|
Public Title of Study
|
Cross-Cultural Adaptation of Kannada version of the Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)
|
|
Scientific Title of Study
|
Cross-Cultural Adaptation, Test-Retest Reliability and Concurrent Validity of Kannada version of the Orebro Musculoskeletal Pain Screening Questionnaire(OMPSQ)
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monalisha Mahapatra |
| Designation |
Master of Physiotherapy student |
| Affiliation |
Institute of Physiotherapy Srinivas university |
| Address |
Department of Physiotherapy
Srinivas university
Pandeshwar
Mangalore
Karnataka
Srinivas University
Pandeshwar
Mangalore
Karnataka
Dakshina Kannada
KARNATAKA
57001
India |
| Phone |
6371330491 |
| Fax |
|
| Email |
monalishamahapatra99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhuripu |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy Srinivas university |
| Address |
Department of Physiotherapy
Srinivas university
Pandeshwar
Mangalore
Karnataka
Srinivas University
Pandeshwar
Mangalore
Karnataka
Dakshina Kannada
KARNATAKA
57001
India |
| Phone |
6371330491 |
| Fax |
|
| Email |
madhuripu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monalisha Mahapatra |
| Designation |
Master of Physiotherapy student |
| Affiliation |
Institute of Physiotherapy Srinivas university |
| Address |
Department of Physiotherapy
Srinivas university
Pandeshwar
Mangalore
Karnataka
Srinivas University
Pandeshwar
Mangalore
Karnataka
Dakshina Kannada
KARNATAKA
57001
India |
| Phone |
6371330491 |
| Fax |
|
| Email |
monalishamahapatra99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Monalisha Mahapatra |
| Address |
Department of physiotherapy
Institute of Physiotherapy
Srinivas university
Pandeshwar
Mangalore
Karnataka
Pin - 575001
Dakshina Kannada
India |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Nil |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monalisha Mahapatra |
Institute of Physiotherapy,Srinivas university Mangalore |
Department of physiotherapy
Institute of Physiotherapy
Srinivas university
Mangalore
Dakshina kannada
Karnataka
Dakshina Kannada
KARNATAKA |
06371330491
monalishamahapatra99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRINIVAS UNIVERSITY ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, |
|
|
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 |
Patient suffering from LBP for atleast 4 to 12 weeks
Age between 18 to 60 years
Both male and female
Patient limited to speaking, reading and writing in kannada
|
|
| ExclusionCriteria |
| Details |
Spinal fracture
spinal surgery in the past 12 months
People with cancer related back pain
inability to read and write kannada
pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Örebro Musculoskeletal Pain Screening Questionnaire
Fear-Avoidance Beliefs Questionnaire |
1st, 6th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
20/08/2024 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Purpose of the study to cross culturaly adapt the Orebro Musculoskeletal pain screening questionnaire into Kannada language |