| CTRI Number |
CTRI/2024/12/077886 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Adapting and Validating the Quebec Back Pain Disability Scale into Kannada (QBPDS-Ka): A Pilot study |
|
Scientific Title of Study
|
Cross cultural Adaptation and Validity of the Quebec Back Pain Disability Scale
Questionnaire (QBPDS) into Kannada (QBPDS - Ka) – A Pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SABANNA |
| Designation |
Post Graduate Student |
| Affiliation |
Ramaiah College Of Physiotherapy |
| Address |
Room 1, Ramaiah College of Physiotherapy, 3rd floor Ramaiah Medical College Hospital, M S Ramaiah Nagar, MSRIT Post, Bangalore 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
06363073934 |
| Fax |
|
| Email |
sabannaningeri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shobhalakshmi S |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah College Of Physiotherapy |
| Address |
Staff Room 1, Ramaiah College of Physiotherapy, 3rd floor Ramaiah Medical College Hospital, M S Ramaiah Nagar, MSRIT Post, Bangalore 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9008025432 |
| Fax |
|
| Email |
shobhaholla.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shobhalakshmi S |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah College Of Physiotherapy |
| Address |
Staff Room 1, Ramaiah College of Physiotherapy, 3rd floor Ramaiah Medical College Hospital, M S Ramaiah Nagar, MSRIT Post, Bangalore 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9008025432 |
| Fax |
|
| Email |
shobhaholla.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| Ramaiah College of Physiotherapy, M S Ramaiah Nagara, MSRIT Post,
Bangalore-560054 |
| Ramaiah Medical College And Hospital, M S Ramaiah Naga, MSRIT Post, Bangalore 560054 |
| Ramaiah Memorial hospital, M S Ramaiah Nagara, MSRIT post,
Bangalore-560054 |
|
|
Primary Sponsor
|
| Name |
SABANNA |
| Address |
Ramaiah College Of Physiotherapy, M S Ramaiah Naga, MSRIT Post, Bangalore 560054 |
| Type of Sponsor |
Other [Myself] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sabanna |
Ramaiah College of Physiotherapy |
Room 1, Ramaiah College of Physiotherapy, 3rd floor Ramaiah Medical College Hospital, M S Ramaiah Nagar, MSRIT Post, Bangalore 560054
Bangalore
KARNATAKA |
06363073934
sabannaningeri@gmail.com |
| Dr Sabanna |
Ramaiah Medical College and Hospital |
Room 1, Ramaiah College of Physiotherapy, 3rd floor Ramaiah Medical College Hospital, M S Ramaiah Nagar, MSRIT Post, Bangalore 560054
Bangalore
KARNATAKA |
6363073934
sabannaningeri@gmai.com |
| Dr Sabanna |
Ramaiah Memorial Hospital |
Room 1, Ramaiah College of Physiotherapy, 3rd floor Ramaiah Medical College Hospital, M S Ramaiah Nagar, MSRIT Post, Bangalore 560054
Bangalore
KARNATAKA |
6363073934
sabannaningeri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with No -specific low back pain.
2. Ability to read and understand Kannada and English. |
|
| ExclusionCriteria |
| Details |
1. Patients with history of spinal surgery, infection, rheumatologic disease, neurological disorders.
2. Serious associate disease that could affect ambulation.
3. Inability to read and understand Kannada and English. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quebec Back Pain Disability Scale (QBPDS) Questionnaire |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil
|
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
Modification(s)
|
06/01/2025 |
| 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)
|
Not Applicable |
| 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
|
Low back pain (LBP) is a widespread musculoskeletal issue, impacting 60-80% of individuals at some point and leading to significant disability due to pain, mobility limitations, and psychological stress. The Quebec Back Pain Disability Scale (QBPDS) is widely used globally to assess LBP-related disability and has been adapted into many languages. However, in India’s linguistically diverse context, a validated Kannada version of the QBPDS is not yet available, despite Kannada being spoken by around 40 million people. Existing tools, like the Oswestry Disability Index, are limited in Kannada due to complex language and cultural differences. This study aims to translate, culturally adapt, and validate the QBPDS for Kannada speakers (QBPDS-Ka), addressing a gap in LBP assessment for clinical and research use in Kannada-speaking populations. |