| CTRI Number |
CTRI/2024/05/067281 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of functional movement exercises on abdominal muscle strength and balance in patient with mechanical low back pain |
|
Scientific Title of Study
|
Effect of functional movement exercises on core strength and balance in patients with mechanical low back pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaunak Narute |
| Designation |
PG student |
| Affiliation |
Dr. D. Y. Patil college of physiotherapy |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9765324677 |
| Fax |
|
| Email |
shaunaknarute123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrudula Sangaonkar |
| Designation |
Associate professor |
| Affiliation |
Dr. D. Y. Patil college of physiotherapy |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8087469330 |
| Fax |
|
| Email |
mrudula.sangaonkar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrudula Sangaonkar |
| Designation |
Associate professor |
| Affiliation |
Dr. D. Y. Patil college of physiotherapy |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8087469330 |
| Fax |
|
| Email |
mrudula.sangaonkar@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil college of physiotherapy pimpri pune. 411018 |
|
|
Primary Sponsor
|
| Name |
Shaunak Narute |
| Address |
Musculoskeletal department, 3rd floor, Dr. D. Y. Patil college of Physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
India |
| Type of Sponsor |
Other [self] |
|
|
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 shaunak Narute |
Dr. D.Y Patil college of physiotherapy Pimpri , Pune 411018 |
Dr. D. Y Patil college of Physiotherapy OPD Ground floor , Pimpri, Pune
Pune
MAHARASHTRA |
9765324677
shaunaknarute123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Dr. D. Y. Patil college of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Functional Movement exercises |
Three sessions in a week for 4 weeks
Warm up
Hot pack
Mini sqauts
Active straight raise
Modified Trunk stability pushup
Full squats
Lunges
Single leg RDL
Cool down |
| Comparator Agent |
ROUTINE PHYSICAL THERAPY |
Three sessions in a week for 4 weeks
Hot pack
Pelvic bridging
Static Back
Static ABS
Back extension
Stretching |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Mechanical low back pain
Moderate NPRS |
|
| ExclusionCriteria |
| Details |
Any Spinal injuries and spine fractures
Spinal deformities Scoliosis, Kyphosis,
Degenerative conditions -spondylosis ,Spondylolisthesis, PIVD
Neurological diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS for pain
Pressure biofeedback for core muscle strength
Balance maOSWESTRY ster- Dynamic Stability – Squats, Lunges
|
Pre 0th week
Post 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
LOW BACK DISABILITY QUESTIONNAIRE
|
pre 0th week
post 4th week
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/05/2024 |
| 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 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
|
Mechanical low
back pain describes back discomfort originating from the muscle imbalance.
Studies have proven that the core
strengthening exercises like Pilates are effective on reducing mechanical low
back pain. Core strengthening enhances the stability of spine and reduce the
discomfort and pain in the back.
Functional
movement exercises are have an integrated movements of spine and lower
extremity. These functional movement exercises can enhance the stability and
mobility of both spine and lower extremity and there by reducing the pain and
improving the functional outcome of daily activities. Functional movement
training improves posture and body awareness, which promotes better alignment
and lowers the chance of injury. This, in turn, supports a lower back that is
pain-free and healthy.
However there is
no specific study had been done on functional movement exercises for reducing
mechanical low back pain. This study uses the impact of functional movement to
address mechanical low back pain. |