| CTRI Number |
CTRI/2025/08/093178 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Hindi Translation of the Istanbul Low Back Pain Disability Index in patients with chronic mechanical low back pain |
|
Scientific Title of Study
|
Hindi Translation, Cross-Cultural Adaptation, Validation and Reliability of Istanbul Low Back Pain Disability Index in patients with Chronic Mechanical 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 |
Renu |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9805557885 |
| Fax |
|
| Email |
renuburathi14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi Popli |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute Of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9896461613 |
| Fax |
|
| Email |
aditi.popli@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Popli |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute Of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9896461613 |
| Fax |
|
| Email |
aditi.popli@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana, India, Pin-133207 |
|
|
Primary Sponsor
|
| Name |
Renu |
| Address |
Maharishi Markandeshwar Institute Of Physiotherapy And Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana-Ambala, Haryana, 133207. |
| 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 Renu |
Maharishi Markandeshwar Institute Of Physiotherapy And Rehabilitation |
Markandeshwar Institute Of Physiotherapy And Rehabilitation Room No.2, Ground floor, Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana.
Ambala
HARYANA
Ambala
HARYANA |
9805557885
renuburathi14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, Maharishi Markandeshwar Institute of Medical Sciences And Research, Mullana-Ambala |
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 |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Having a history of chronic mechanical low back pain lasting more than 3 months.
2. Both males and females will be included. |
|
| ExclusionCriteria |
| Details |
1. Acute mechanical or non-mechanical low back pain (less than 3 months).
2. Patients with serious cognitive Impairments, infectious and inflammatory disorders, malignancy that causes Chronic Low Back Pain.
3. Pregnant ladies and children.
4. Patients who does not speak Hindi language.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Istanbul Low Back Pain Disability Index (ILBPDI) scale |
At baseline (Immediately after recruitment) and
Within 72 hours of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/09/2025 |
| 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="8"
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 original Istanbul Low Back Pain Disability Index scale (ILBPDI), developed in a
Western context, may not fully capture culturally specific stressors, social
influences, or triggers experienced by low back pain population in India. In
India, a vast population speaks Hindi, in addition to this, it is very
challenging for them to understand English or any other language. Even if the
therapist explains the items and contents in native Hindi language there is a
great probability that the subject can misinterpret as the verbal meaning of
words may not express the appropriate meaning as in the original questionnaire.
This study will be of great importance and will aid the general population who
cannot read and speak English. Translation of the ILBPDI scale for low back
pain patients will add more meaning to the literature for the future. Therefore it enables the more
accurate assessment of ILBPDI scale in chronic mechanical low back pain
patients among Hindi-speaking populations, which will ultimately be
contributing to more effective assessment strategies and improved public health
outcomes in India. This
study aims to translate each domain of the Istanbul Low Back Pain Disability
Index scale (ILBPDI) into Hindi, to assess its validation, and evaluate
test-retest reliability among Hindi-speaking populations. The aim is also to
create an official Hindi version of the questionnaire. The
study method involves translating the Istanbul Low Back Pain Disability Index scale (ILBPDI) from English into Hindi by two translators, T1 and T2,
with medical and non-medical backgrounds, respectively. The recording
observer then takes a seat to create a T12 version of the
translated questionnaire. The reverse translation from the T12 form to the
previous form is now being done. Then, an expert panel analyses all the stages
and all of the questionnaire items to ensure that the translated form of
the questionnaire is free of errors, allowing it to be field tested. Evaluation
of the content’s validity is done. The pre-final form is then fully tested on
patients, and the scale’s validity is reported. Finally, the translated
questionnaire version will be analyzed by the ethics committee. |