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CTRI Number  CTRI/2024/11/076162 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 30/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Evidence of Spine strengthening Excercises causing improvement in patients with Spinal pathologies. 
Scientific Title of Study   Association of Lumbar Paraspinal Muscle Morphometry in patients with Severe Lower Backache. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashlee Isaac 
Designation  Post graduate (MS Orthopaedics) 
Affiliation  SRM Medical College and Research Institute 
Address  2nd floor, Department of Orthopaedics,SRM Medical college and Research Institute, Kattankulathur,603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  07395975270  
Fax    
Email  ashleeisaac12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijay Anand B 
Designation  HOD,Department of Orthopaedics 
Affiliation  SRM Medical College and Research Institute 
Address  2nd floor, Department of Orthopaedics,SRM Medical college and Research Institute, Kattankulathur,603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  09790963468  
Fax    
Email  vijayanb@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ashlee Isaac 
Designation  Post graduate (MS Orthopaedics) 
Affiliation  SRM Medical College and Research Institute 
Address  SRM Medical college and Research Institute, Kattankulathur, TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  07395975270  
Fax    
Email  ashleeisaac12@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical college and Research Institute, Kattankulathur,603203. 
 
Primary Sponsor  
Name  SRM 
Address  Department of Orthopaedics, 2nd floor, SRM Medical College Hospital And Research Centre, SRM Nagar, Potheri, Chengalpattu, Tamil Nadu 603203. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashlee Isaac   SRM Institute of Science and Technology  2nd floor, Department of Orthopaedics, SRM Medical college and Research Institute, Kattankulathur, TAMIL NADU 603203 India
Kancheepuram
TAMIL NADU 
07395975270

ashleeisaac12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Institutional Ethics Committee- Students  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G318||Other specified degenerative diseases of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  85.00 Year(s)
Gender  Female 
Details  Female sex,
Age of 65–85 years,
Patients with the Presence of LS - Spine MRI study,
The patients with complaints of Polyradiculopathy at the Lumbar - spine level.
 
 
ExclusionCriteria 
Details  1.Patients with polyneuropathy,
2.Previous lumbosacral spinal surgery,
3.Systemic disorders,
4.spinal fractures,
5.Tumors,
6.Infections  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the cross-sectional areas (CSA) of lumbar paraspinal muscles and their fatty degeneration in adults with spinal pathologies causing severe lower back pain and evaluate their correlations and the changes observed on magnetic resonance imaging (MRI) .  After taking an MRI Scan 
 
Secondary Outcome  
Outcome  TimePoints 
To see if the functional muscle mass with out the fat degeneration,is decreased in patients with Spondylolisthesis.  After taking an MRI Scan 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   15/11/2024 
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="1"
Months="0"
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  

Purpose :The study provides a basis for Spinal Stabilization excercises and Physiotherapy.Aging leads to atrophy of Muscle Mass and  can be replaced by connective tissues such as fat,which is called Sacropenia,Which occurs with aging.

 Methodology :The study is a prospective study. The study population includes all patients with lower backache who underwent MRI.

The patient were divided into two groups :

-Patients with severe spinal pathologies (Degenerative Spondylolisthesis,Disc prolapse,Disc Extrusion)

-Patients without severe spinal pathologies.

In the MRI images,Cross Sectional areas of Multifidus And Erector Spinae We measured by manually tracing the fascial boundaries If the Muscles.

Qualitative measurements of the muscles were obtained between Muscle (low signal) and fast tissue (high signal).

The Functional Cross sectional area(FCSA) : Cross section area ratio &

MF CSA: ES CSA ratio will be calculated and compared between the two groups by using an independent t-test.

Conclusions :

•The  study provides a basis for spinal stabilization exercise and physiotherapy.

•               The MultiFidus muscle is an important stabilizer of the lumbar spine neutral zone, and atrophy of the muscle decreases the ability to control the neutral zone and is strongly associated with Lower Back Pain .

•               Spinal stabilization has been observed to be more effective over time in treating lower back pain than minimal intervention and exercise therapy alone. Therefore, the treatment focus has shifted to reactivation and strengthening of the smaller muscles of the spine to improve long-term stabilization of the vertebral column .

 
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