| CTRI Number |
CTRI/2025/03/082504 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translating and validating the graded chronic pain scale revised into tamil |
|
Scientific Title of Study
|
Translation and validation of tamil version of graded chronic pain scale -revised (gcps-r) in individuals with chronic non -specific 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 |
Kotagiri AVL Harika |
| Designation |
Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
NO.1,Sri Ramachandra Nagar
Porur ,Chennai -600116.
Chennai
TAMIL NADU
600116
India |
| Phone |
09884218383 |
| Fax |
|
| Email |
harikak2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr SUBBIAH K |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
NO.1, Sri Ramachandra Nagar
Porur, Chennai -600116.
Chennai
TAMIL NADU
600116
India |
| Phone |
09443033118 |
| Fax |
|
| Email |
subbiah@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr SUBBIAH K |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
NO.1, Sri Ramachandra Nagar
Porur, Chennai -600116.
Chennai
TAMIL NADU
600116
India |
| Phone |
09443033118 |
| Fax |
|
| Email |
subbiah@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kotagiri AVL Harika |
| Address |
NO.1, Sri Ramachandra Nagar
Porur, Chennai -600116. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Kotagiri AVL Harika |
Sri Ramachandra Faculty of Physiotherapy Sri Ramachandra Institute of Higher Education And Reseach |
Physical Rehabilitation Department, Ground floor, new block OPD, Faculty of Physiotherapy Sri Ramachandra Institute of Higher Education and Research NO.1, Sri Ramachandra Nagar
Porur, Chennai -600116.
Chennai
TAMIL NADU |
09884218383
harikak2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Chronic Non-specific low back pain patients
Both male and female
Age group of 30-60 years of age |
|
| ExclusionCriteria |
| Details |
Patients with cognitive impairments
Patients who are not able to independently ambulate
Patients with multiple comorbidities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Roland-Morris Low Back Disability Questionnaire |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain Catastrophizing Scale |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/03/2025 |
| 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="0"
Months="3"
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
|
Chronic non-specific low back pain is the low back pain that persists for more than 12 weeks and has no identified pathology. The GRADED CHRONIC PAIN SCALE -REVISED (GCPS-R) evaluates the global severity of chronic pain based on pain intensity and pain-related disability. The author original version of Graded Chronic Pain Scale -Revised (GCPS-R) is Prof. Michael VonKorff et all which was published and validated in March 2020. The GRADED CHRONIC PAIN SCALE -REVISED (GCPS-R) has been translated into 2 languages and validated into 1 language The Tamil version has not been done yet, if done could improve the management of chronic low back pain. |