| CTRI Number |
CTRI/2024/07/069924 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Test-retest design |
| Study Design |
Other |
|
Public Title of Study
|
Cross-cultural adaptation, Test-retest reliability and concurrent validity |
|
Scientific Title of Study
|
Cross cultural adaptation test retest reliability and concurrent validity of the Kannada version of the Brief illness perception questionnaire in patients with chronic nonspecific low back pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samiksha S Shetty |
| Designation |
Master of physiotherapy student |
| Affiliation |
Institute of physiotherapy |
| Address |
Department of physiotherapy
Institute of physiotherapy, Srinivas University, Mangalore
Department of physiotherapy
Institute of physiotherapy, Srinivas University, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8431945911 |
| Fax |
|
| Email |
samikshaa.s760@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajasekar |
| Designation |
Dean and Professor |
| Affiliation |
Institute of physiotherapy, Srinivas University, Mangalore |
| Address |
Department of Physiotherapy
Institute of Physiotherapy, Srinivas University, Mangalore
Department of physiotherapy
Institute of physiotherapy, Srinivas University, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8431945911 |
| Fax |
|
| Email |
rajasekar@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Samiksha S Shetty |
| Designation |
Master of physiotherapy student |
| Affiliation |
Institute of physiotherapy, Srinivas University, Mangalore |
| Address |
Department of physiotherapy
Institute of physiotherapy, Srinivas University, Mangalore
Department of physiotherapy
Institute of physiotherapy, Srinivas University, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8431945911 |
| Fax |
|
| Email |
samikshaa.s760@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Samiksha S Shetty |
| Address |
Department of Physiotherapy
Institute of Physiotherapy,
Srinivas University, Mangalore,575001, Dakshina Kannada, 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 Samiksha S Shetty |
Institute of physiotherapy Srinivas University Mangalore |
Department of physiotherapy
Institute of physiotherapy Srinivas University Mangalore
Dakshina Kannada
KARNATAKA |
8431945911
samikshaa.s760@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: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chronic nonspecific LBP for at least 12 weeks
Both male and female
Able to read and write Kannada
Age of 18 to 65 years |
|
| ExclusionCriteria |
| Details |
LBP with neurological signs and symptoms
Cancer related back pain
History of mental illness or psychotic disorders
Pregnancy related back pain
Spinal infections
Inflammatory diseases of the spine
Spinal fractures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Brief illness perception questionnaire
Visual analogue scale
Oswestry disability index |
Day 1 and Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
15/07/2024 |
| 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="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
|
It is a study on Cross cultural adaptation Test-retest reliability and concurrent validity of the Kannada version of the Brief illness perception questionnaire in Chronic nonspecific low back pain. The aim is to culturally adapt and translate the original version of BIPQ into Kannada version as well as to evaluate the test-retest reliability and concurrent validity in a sample of patients with chronic nonspecific LBP. |