| CTRI Number |
CTRI/2025/07/091398 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
A Mix methods quality and quantitative study |
| Study Design |
Other |
|
Public Title of Study
|
A study to translate the Roland-Morris disability questionnaire into the Gujarati language and test how well it works in participants with low back pain |
|
Scientific Title of Study
|
Gujarati Translation Cross cultural adaptation and Psychometric properties of Roland Morris Disability Questionnaire in low Back pain A Mixed Methods Quality and Quantitative 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 |
Dhruv Jain |
| Designation |
Clinician |
| Affiliation |
Reactive Physiotherapy Clinic and Fitness Centre |
| Address |
M/30 2nd Floor Someshwar Square, Opposite Someshwar Enclave, Vesu, Surat
Surat
GUJARAT
395007
India |
| Phone |
75285855461 |
| Fax |
|
| Email |
jaindrdhruv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yagna Unmesh Shukla |
| Designation |
Principal |
| Affiliation |
Government Physiotherapy college and spine institute |
| Address |
First floor, Principal office, Government Physiotherapy college and spine Institute, Civil hospital, Asarwa road, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9824098874 |
| Fax |
|
| Email |
yagnashukla28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yagna Unmesh Shukla |
| Designation |
Principal |
| Affiliation |
Government Physiotherapy college and spine institute |
| Address |
First floor, Principal office, Government Physiotherapy college and spine Institute, Civil hospital, Asarwa road, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9824098874 |
| Fax |
|
| Email |
yagnashukla28@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dhruv jain |
| Address |
M/30 2nd Floor Someshwar Square, Opposite Someshwar Enclave, Vesu, Surat- 395007 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Disharth Jain |
Reactive physiotherapy clinic and fitness centre |
M/30 2nd Floor Someshwar Square, Opposite Someshwar Enclave, Vesu, Surat- 395007
Surat
GUJARAT |
8153975857
disharthjain98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSIPT INSTITUTIONAL ETHICS COMMITTEE |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Willingness to participate
2) Written informed consent
3) Patient with low back pain with or without radiating pain
4) The patient should be able to read and comprehend the Gujarati language
• Cognitive sound |
|
| ExclusionCriteria |
| Details |
1) Medical Red Flags |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Analysis of Psychometric Properties (Validity and reliability) of the Gujarati translated and Cross-culturally adapted version of the Roland-Morris Disability
Questionnaire |
At Baseline
At 4 weeks
At 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/01/2026 |
| 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="3"
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
|
The Roland-Morris disability questionnaire is widely used in
clinical practice to track the development of patients with acute, subacute,
and chronic low back pain, including primary care, injured workers, and
multidisciplinary rehabilitation centers. This scale is available in many
languages, but not in the Gujarati language. This study aims to translate and
cross-culturally adapt the Roland-Morris disability questionnaire in the Gujarati
language. This study is a mixed-methods methodological study, including a quantitative
and qualitative component. This study includes 6 stages: Stage 1- Forward translation of the English version of the Roland-Morris
disability questionnaire into Gujarati, Stage 2- Synthesis of translation
and resolution of discrepancies with the translator’s report, Stage 3- Back
translation into English, Stage 4- Expert committee review of pre-final version,
Stage 5- Pre-testing will be done by assessing reliability and validity, stage
6- Submission Then, a Gujarati translated and culturally adapted version
of the Roland-Morris disability questionnaire will be available. |