| CTRI Number |
CTRI/2024/08/072750 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effects of Williams flexion exercises vs. Motor control exercises on patients with Mechanical Low Back pain |
|
Scientific Title of Study
|
Effect of williams flexion exercises versus motor control exercises on pain and function on subjects with Mechanical Low Back Pain - A comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
soni drashti |
| Designation |
MPT Scholar |
| Affiliation |
parul institute of physiotherapy |
| Address |
room no. 201 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
7202820175 |
| Fax |
|
| Email |
sonidrashti3349@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Didhiti Desai |
| Designation |
Associate professor |
| Affiliation |
parul institute of physiotherapy |
| Address |
room no. 201 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8866458302 |
| Fax |
|
| Email |
didhiti1987@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Didhiti Desai |
| Designation |
Associate professor |
| Affiliation |
parul institute of physiotherapy |
| Address |
room no. 201 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8866458302 |
| Fax |
|
| Email |
didhiti1987@gmail.com |
|
|
Source of Monetary or Material Support
|
| room no. 201 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, Gujarat, India
Pincode : 3911760 |
|
|
Primary Sponsor
|
| Name |
soni drashti |
| Address |
room no. 201 , 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, Gujarat, India
Pincode : 391760 |
| 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 |
| DrDrashti Soni |
Parul institute of physiotherapy |
room no. 201, 3rd floor, parul institute of physiotherapy, parul university, post limda, waghodia, Gujarat, India
Pincode : 391760
Vadodara
GUJARAT |
07202820175
sonidrashti3349@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| parul university institutional ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
mechanical low back pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise therapy
Williams flexion exercises |
Williams’ Flexion Exercises
The William Flexion Exercise aims to relieve back pain by stretching the extensor muscle group and strengthening the muscles that represent the lumbosacral spine, especially the abdominal and maximal gluteus muscles. Additionally, it prevents tight intervertebral joints, lessens muscular spasms through a smoothing action, and checks poor posture
Sit ups
Pelvic tilt
Single knee to chest
Double knee to chest
Seated reach to the toes
Quadruped position with one knee forward
Full squat
three repetitions and 10 second break. One session / day for 6 days. |
| Comparator Agent |
Motor Control Exercise |
Motor Control Exercise
Motor control exercise was developed based on the principle that individuals with LBP have a lack of control of the trunk muscles. The idea is to use a motor learning approach to retrain the optimal control and coordination of the spine. The intervention involves the training of pre activation of the deep trunk muscles, with progression toward more complex static, dynamic, and functional tasks integrating the activation of deep and global trunk muscle
Sitting knee extension
4 point kneeling & rocking pelvis backward
Crook lying – posterior pelvic tilt
prone lying knee flexion
Crook lying abduction
Clamshells
Prone lying SLR
three repetitions and 10 second break. One session / day for 6 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 18-30 years
2.Male and Female Population
3.Acute and Sub Acute Pains
4.VAS score More than 5 and less than 7
5.Willing participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Fractures (spine , rib) or Injury.
2.Any Abdominal Surgery.
3.Systemic illness.
4.Spinal or disc Pathologies.
5.Ankylosing Spondylosis, Inflammatory, Rheumatological diseases.
6.Lower limb surgeries (or) scheduled for surgery.
7.Spondylolisthesis, Spondylosis, Spinal Stenosis, Osteoporosis.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Oswestry Disability Index (ODI) |
6 days / week
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
22/08/2024 |
| 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="0"
Months="6"
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
|
Low back pain (LBP) is experienced by 60%–80% of adults at some point in their lifetime, in which prevalence of mechanical pain is seen in most of the patients. Low back pain leads to significant morbidity placing strict activity limitations to the patients. The purpose of study is to find out the effectiveness of William Flexion Exercise and motor control exercise in Mechanical low back Pain.. There are very few studies which focus mainly William’s Flexion Exercise and Motor Control exercises individually on mechanical low back pain to understand the actual difference pre and post intervention.
• William’s Flexion Exercise & Motor Control Exercise is useful for low back pain • |