| CTRI Number |
CTRI/2024/10/075382 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of Backache screening tool in adult patients with non specific lower backache to classify patients into mild, moderate and severe grade. |
|
Scientific Title of Study
|
Development of Backache screening tool in adult population with non specific lower backache and its clinical validation by its ability to classify patients into mild, moderate and severe grade. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Iknoor Singh Mann |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
Department of Orthopedics
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7009433122 |
| Fax |
|
| Email |
Iknoormann98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Kiran V Acharya |
| Designation |
Professor and HoD of Department of Orthopaedics |
| Affiliation |
KMC, Manipal |
| Address |
Department of Orthopedics
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448130539 |
| Fax |
|
| Email |
kiran.acharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Iknoor Singh Mann |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
Department of Orthopedics
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7009433122 |
| Fax |
|
| Email |
Iknoormann98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthopaedics, Kasturba Hospital, KMC Manipal, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Department of orthopaedics KMC Manipal |
| Address |
Department of Orthopedics KMC Manipal |
| Type of Sponsor |
Private 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 Iknoor Singh Mann |
Kasturba Hospital Manipal |
Department of Orthopedics
Kasturba Hospital Manipal
Udupi
KARNATAKA |
7009433122
iknoormann98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba Hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M489||Spondylopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All patients presenting to general OPD with non specific lower backache in-between 18 to 75 years of age |
|
| ExclusionCriteria |
| Details |
Traumatic spinal injuries, operated spine pathologies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of new backache screening tool in adult population with non specific lower backache and its clinical validation by comparing with standard Keele start backache scoring tool and its ability to classify patients into mild, moderate and severe grade |
At the time of initial assesment of patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of new backache screening tool in adult population with non specific lower backache |
at time of initial assesment of patient |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
01/11/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 will be a prospective descriptive study conducted within the usual clinical care of CLBP patients.
From among OPD based chronic pain patients treated at pain management centers in KMC Manipal University between 2023 and 2025, All patients with CLBP will be enrolled in this study after completion of the questionnaires at the 3-month follow-up. The patients suffering from CLBP with or without radiculopathy due to lumbar spinal stenosis, lumbar disc herniation, myofascial issues, and other causes of pain. The inclusion criteria in this study will be the patients from 20 to 85 years with LBP which will define as experiencing pain, discomfort and stiffness in the lower back from the 12th rib to the lumbar or lumbo-sacral area, including low back pain symptoms. Patients will be subjected to new backache screening tool and standard Keele start backache scoring tool and patients will be classified as mild, moderate and severe grade.
|