| CTRI Number |
CTRI/2026/03/106975 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
22/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to observe lower back changes in police staff aged 35 to 58 years with lower back pain using MRI |
|
Scientific Title of Study
|
An Observational Study To Find Structural Involvement And Changes In The Lumbosacral Spine Among Police With The Age Group Of 35-58 Years Having Katigraha Using Magnetic Resonance Imaging Scan. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayali Moreshwar Sawsakade |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi, Pune |
| Address |
PDEAs college of ayurved and research centre Rachana Sharir department,ground floor,room no.1,sector 27,Nigdi,Pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
9075120585 |
| Fax |
|
| Email |
sawsakadesayali29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Bhanage |
| Designation |
Professor Rachana Sharir Department |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi, Pune |
| Address |
PDEAs college of ayurved and research centre Rachana Sharir department,ground floor,room no.1,sector 27,Nigdi,Pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
9130099663 |
| Fax |
|
| Email |
mmbhanage@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Bhanage |
| Designation |
Professor Rachana Sharir Department |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi, Pune |
| Address |
PDEAs college of ayurved and research centre Rachana Sharir department,ground floor,room no.1,sector 27,Nigdi,Pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
9130099663 |
| Fax |
|
| Email |
mmbhanage@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research centre Rachana Sharir department ground floor Nigdi Pune Maharashtra 411044 India |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurveda and research centre,Nigdi ,Pune |
| Address |
PDEAs college of ayurved and research centre Rachana Sharir department ground floor Nigdi Pune Maharashtra 411044 India |
| 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 |
| Dr Sayali Moreshwar Sawsakade |
PDEAs Ayurved Rugnalaya and sterling multispeciality hospital |
opd no 117 department of kayachikitsa PDEAs Ayurved Rugnalaya and sterling and multispeciality hospital Nigdi Pradhikaran Pune Maharashtra India
Pune
MAHARASHTRA |
9075120585
sawsakadesayali29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy police man with prior diagnosed of Katigraha who have done mri can of lumbosacral spine will be will be selected |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
1.Police with a prior diagnosis of katigraha who have done MRI scan of lumbosacral spine will be selected.
2.Age group of 35-58 years irrespective of gender,religion,marital status,socioeconomic status. |
|
| ExclusionCriteria |
| Details |
1.Police officers engaged primarily in desk-based duties.
2.Person having history of major trauma or surgery in the lumbar spine.
3.Known cases of HIV and TB
4.Post-operated patient of lumbo-sacral spine.
5.Pregnant women
6.Known cases of congenital spinal deformities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find structural involvement and changes in the lumbosacral spine among spine among police having katigraha using magnetic resonance imaging scan. |
1 time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
06/04/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 observational study focuses on identifying structural changes in the lumbosacral spine of police personnel aged 35–58 years who are suffering from Katigraha. Katigraha is an Ayurvedic condition characterized by pain, stiffness, and restricted movement in the lower back, often associated with degenerative spinal disorders.Police personnel are considered a high-risk occupational group for lower back problems due to factors such as prolonged standing, heavy physical work, long duty hours, and stress. The study uses Magnetic Resonance Imaging (MRI) to observe and document structural abnormalities in the lumbosacral spine, including:Intervertebral disc degeneration,Disc bulging or herniation,Spinal canal narrowing,Ligament or soft tissue changes,Vertebral alignment abnormalities
The main objective is to correlate the clinical symptoms of Katigraha with structural findings on MRI scans. By doing this, the study aims to better understand the underlying anatomical changes responsible for lower back pain in police personnel.
The findings may help in: Early diagnosis of spinal degeneration,Better management and treatment planninDeveloping preventive strategies for police with occupational strain
Overall, the study highlights the importance of MRI in detecting structural involvement of the lumbosacral spine in patients with Katigraha, especially in physically demanding professions like policing. |