| CTRI Number |
CTRI/2024/05/066917 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Low Back Pain in Western Rajasthan: A Clinical Study at a Tertiary Care Center |
|
Scientific Title of Study
|
Clinical profile of person with low back pain visiting a tertiary care center in western Rajasthan |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abins T K |
| Designation |
Senior Resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Room no 2 OPD, PMR department AIIMS JODHPUR.
342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09947332918 |
| Fax |
|
| Email |
abiabin11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abins T K |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS JODHPUR |
| Address |
OPD No 2,Department of Physical Medicine Rehabilitation,AIIMS Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9947332918 |
| Fax |
|
| Email |
abiabin11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abins T K |
| Designation |
Senior resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Physical Medicine Rehabilitation
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09947332918 |
| Fax |
|
| Email |
abiabin11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physical medicine and rehabilitation,AIIMS Jodhpur |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrABINS TK |
Department of Physical medicine and rehabilitation,AIIMS Jodhpur. |
Department of Physical Medicine Rehabilitation,OPD No 2 AIIMS JODHPUR
Jodhpur
RAJASTHAN |
9947332918
abiabin11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AllMS Jodhpur 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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Age: 18-65 years
Pain Duration: ≥ 4 weeks
Pain Severity NRS More than 2
Pain Location (low back)
|
|
| ExclusionCriteria |
| Details |
Previous Spine Surgery
Serious Medical Conditions
Neurological Conditions Like TBI and stroke
Pregnancy
Active systemic infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess diagnostic profile in patient with low back pain |
cross sectional study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. to assess Low back pain in NRS scale |
assessing only one point of study, cross sectional study |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
15/05/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study, approved by the Institutional Ethics Committee, aims to understand the clinical profile of individuals with low back pain at the AIIMS Jodhpur PMR OPD in western Rajasthan. We will recruit 384 participants aged 18-65 years with a confirmed diagnosis of low back pain lasting at least 4 weeks.we include patints visting PMR OPD with low back pain ,Age 18-65 years and exclude ,Previous spinal surgery,Serious underlying medical conditions,Neurological conditions like TBI,Stroke,Pregnancy.patient assesment include demographic information (age, gender, occupation, medical history) to understand the typical patient profile. Pain severity will be quantified using the Numeric Rating Scale (NRS) (0-10). A comprehensive neurological examination will assessmotor and sensory functions. A thorough physical examination (head-to-toe) will identify potential contributing factors like posture, range of motion, muscle strength, and tenderness. X-ray and/or MRI scans used as needed to visualize the spine and identify structural abnormalities. Objectives:Analyze demographics, pain characteristics (intensity and duration using NRS), neurological function, physical examination findings, and potential associations with imaging results of participants with low back pain. This will help develop more targeted treatment strategies and resource allocation for low back pain management. Ethical Considerations: Informed consent will be obtained from all participants. Participant confidentiality will be maintained. The study protocol has been approved by the Institutional Ethics Committee. |