| CTRI Number |
CTRI/2025/01/079359 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Low Back Pain in Indian Adults: Insights from a 5-Year data from EMR |
|
Scientific Title of Study
|
Low Back Pain and its Management in Adults: A Real-World Retrospective Study in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MC/MA/LBP/24-001 Version 1.0 dated 7/10/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishikant Madkholkar |
| Designation |
Medical Advisor |
| Affiliation |
Alkem Laboratories Ltd. |
| Address |
Alkem House, Senapati Bapat Marg,
Lower Parel,
Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
9673607443 |
| Fax |
|
| Email |
nishikant.madkholkar@alkem.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishikant Madkholkar |
| Designation |
Medical Advisor |
| Affiliation |
Alkem Laboratories Ltd. |
| Address |
Alkem House, Senapati Bapat Marg,
Lower Parel,
Mumbai
MAHARASHTRA
400013
India |
| Phone |
9673607443 |
| Fax |
|
| Email |
nishikant.madkholkar@alkem.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishikant Madkholkar |
| Designation |
Medical Advisor |
| Affiliation |
Alkem Laboratories Ltd. |
| Address |
Alkem House, Senapati Bapat Marg,
Lower Parel,
Mumbai
MAHARASHTRA
400013
India |
| Phone |
9673607443 |
| Fax |
|
| Email |
nishikant.madkholkar@alkem.com |
|
|
Source of Monetary or Material Support
|
| Alkem Laboratories Ltd
Alkem House, Senapati Bapat Marg, Lower Parel, Mumbai
Mumbai
MAHARASHTRA
400013
India |
|
|
Primary Sponsor
|
| Name |
Alkem Laboratories Ltd |
| Address |
Alkem House, Senapati Bapat Marg,
Lower Parel,
Mumbai-400013
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Nishikant Madkholkar |
Alkem Laboratories |
Medical Affairs department, Alkem House, Senapati Bapat Marg, Lower Parel, Mumbai - 400013, Maharashtra India.
Mumbai
MAHARASHTRA |
9673607443
nishikant.madkholkar@alkem.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with low back pain by treating physician
Electronic Medical Record EMR of patient dated between Jan 1 2019 and 31 Dec 2023
|
|
| ExclusionCriteria |
| Details |
Information on age, weight, or sex of patient missing in electronic medical record EMR
Incomplete information available with respect to medication prescribed for low back pain or other data required for endpoint analysis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study outcomes will include the prevalence of LBP across demographic and clinical subgroups, the distribution of treatment practices among various medical specialties, and the utilization of medication classes such as NSAIDs and calcium supplements. |
single timepoint between Jan 2019 to Dec 2023 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Prevalence of low back pain categorized by sex, BMI, age group, and comorbidities.
-Proportion of patients with low back pain treated by physicians of different medical specialties.
|
single timepoint between Jan 2019 to Dec 2023 |
|
|
Target Sample Size
|
Total Sample Size="16866"
Sample Size from India="16866"
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)
|
03/02/2025 |
| 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="6"
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
|
This study is a retrospective, real-world evidence (RWE) analysis of low back pain (LBP) management in Indian adults, utilizing electronic medical records (EMRs) January 2019 to December 2023. It explores the prevalence of LBP across various demographic and clinical categories, examines treatment approaches across medical specialties, and highlights medication usage patterns, including NSAIDs and calcium supplements. By adhering to ethical research guidelines, this study seeks to uncover evolving trends in LBP management, providing critical insights to inform clinical practices and enhance patient care in India |