| CTRI Number |
CTRI/2024/11/077191 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
cross-cultural adaptation, validation, and psychometric analysis study |
| Study Design |
Other |
|
Public Title of Study
|
Cross-cultural Adaptation and Validation of Bengali Version of the McGill Pain Questionnaire for Low Back Pain of Long Duration in Bengali Population |
|
Scientific Title of Study
|
Cross-cultural Adaptation and Validation of Bengali Version of the McGill Pain Questionnaire for Chronic Low Back Pain in Bengali Population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anoovab Saha |
| Designation |
Post Graduate Trainee |
| Affiliation |
R. G. Kar Medical College and Hospital, Kolkata |
| Address |
Room No. 110, OPD Building, Dept. of Physical Medicine and Rehabilitation, R. G. Kar Medical College and Hospital
1, Khudiram Bose Sarani, Kolkata
Kolkata
WEST BENGAL
700004
India |
| Phone |
9734343014 |
| Fax |
|
| Email |
anoovab.saha96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Mandal |
| Designation |
Professor and Head, Department of PMR, RGKMCH |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Dept. of PMR, R. G. Kar Medical College, 1, Khudiram Bose Sarani, Kolkata
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433915696 |
| Fax |
|
| Email |
rehabyouall@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar Mandal |
| Designation |
Professor and Head, Department of PMR, RGKMCH |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Dept. of PMR, R. G. Kar Medical College, 1, Khudiram Bose Sarani, Kolkata
WEST BENGAL
700004
India |
| Phone |
9433915696 |
| Fax |
|
| Email |
rehabyouall@gmail.com |
|
|
Source of Monetary or Material Support
|
| R. G. Kar Medical College, 1, Khudiram Bose Sarani, Kolkata- 700004, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
R. G. Kar Medical College, Kolkata |
| Address |
1, Khudiram Bose Sarani, Kolkata- 700004 |
| Type of Sponsor |
Government medical college |
|
|
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 Anoovab Saha |
R. G. Kar Medical College and Hospital |
Department of Physical Medicine and Rehabilitation, Room No. 110, Ground Floor, OPD Building
Kolkata
WEST BENGAL |
9734343014
anoovab.saha96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, R. G. Kar Medical College |
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 |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Patients who can read, write, and understand Bengali
Patients diagnosed clinically with non-specific chronic low back pain
Symptoms persisting for at least 3 months
|
|
| ExclusionCriteria |
| Details |
Any chronic low back pain with neuropathic component
Hearing disability
Inability to write
Confused state
Patients needing emergency care
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check if the Bengali version is equivalent to the original version of the McGill Pain Questionnaire. |
at baseline (Day 0) and Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To make the Bengali version of the McGill Pain Questionnaire a valid and reliable tool for assessing pain status in Bengali speaking patients. |
Day 0, Day 3 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/12/2024 |
| 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="9"
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 McGill Pain Questionnaire (MPQ) is a very useful multidimensional instrument to assess the pain status of patients as it assesses both the quality and intensity of subjective pain. But no validated equivalent Bengali version of this tool is not available although Bengali is spoken by approx. 272 million people all over the world. This is a cross-cultural adaptation, validation, and psychometric analysis study. It will be conducted in R G Medical College and Hospital, a tertiary care centre in Kolkata, West Bengal. The study will adhere to ethical guidelines and obtain the necessary approvals from the institutional review board. Study will be done after taking consent from all the participants. All data will be collected, compiled, and subjected to suitable statistical analysis using available statistical software and results will be discussed. The cross-culturally adapted Bengali version of the McGill Pain Questionnaire may be a valid and multidimensional pain assessment tool for all the Bengali speaking population. The use of this Bengali version of MPQ can assist in comprehensive pain assessment aiding management and improved patient care. |