| 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
|
|
|
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
|
|
|
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 . |