| CTRI Number |
CTRI/2024/07/071442 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| 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 the Kannada version of The chronic pain acceptance questionnaire revised(CPAQ-R) |
|
Scientific Title of Study
|
Cross-cultural adaptation test retest reliability and concurrent validity of the Kannada version of the chronic pain acceptance questionnaire revised (CPAQ-R) in chronic low back pain patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranita Priyadarshini |
| Designation |
Master of physiotherapy student |
| Affiliation |
Institute of physiotherapy srinivas university |
| Address |
Department of physiotherapy srinivas university pandeswar mangaluru dakshina kannada karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6372010567 |
| Fax |
|
| Email |
pranita.priya.027@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rajasekar |
| Designation |
Dean and Professor |
| Affiliation |
Department of physiotherapy,srinivas university |
| Address |
Department of physiotherapy Institute of physiotherapy Srinivas university pandeswar Mangaluru Dakshina kannada Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6372010567 |
| Fax |
|
| Email |
rajasekar@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Pranita Priyadarshini |
| Designation |
Master of physiotherapy student |
| Affiliation |
Department of physiotherapy,srinivas university |
| Address |
Department OF PHYSIOTHERAPY SRINIVAS UNIVERSITY, PANDESWAR MANGALURU ,DAKSHINA KANNADA,KARNATAKA
KARNATAKA
575001
India |
| Phone |
6372010567 |
| Fax |
|
| Email |
pranita.priya.027@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pranita Priyadarshini |
| Address |
Department of physiotherapy srinivas university pandeswar mangaluru dakshina kannada karnataka India |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Pranita Priyadarshini |
Institute of physiotherapy Srinivas university Mangaluru |
Department of physiotherapy Institute of Physiotherapy Srinivas university Mangaluru
Dakshina Kannada
KARNATAKA |
6372010567
pranita.priya.027@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-M95||Other disorders of the 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 |
Patients suffering from LBP for at least 3 months or 3 episodes in a year
Age between 18 and 60 years
Both male and female
Patient limited to speaking, reading, and writing Kannada.
|
|
| ExclusionCriteria |
| Details |
Pregnancy
People with cancer-related pain.
Neurological disorders
Spine Fracture
Unstable Angina and Cerebrovascular events.
Back pain due to any other systemic illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Chronic Pain Acceptance Questionnaire-Revised
Oswestry Disability Index (ODI)
Visual Analogue Scale-pain |
1st, 6th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
10/08/2024 |
| 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 is to translate and cross-culturally adapt the original version of CPAQR into Kannada language and also to analyse concurrent validity and test-retest reliability in a group of individuals suffering from chronic LBP. |