| CTRI Number |
CTRI/2020/06/025813 [Registered on: 11/06/2020] Trial Registered Prospectively |
| Last Modified On: |
09/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision between Strengthening Exercises and Low Resistance Exercises with minimal movements for Low Back Pain Patients. |
|
Scientific Title of Study
|
Effect Of Kinetic Control And Lumbar Stabilization Exercises In Patients With Mechanical Low Back Pain:A Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roopa Desai |
| Designation |
Associate Professor |
| Affiliation |
Dr.D.Y.Patil College of Physiotherapy |
| Address |
Dr.D.Y.Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9890992383 |
| Fax |
|
| Email |
roopa.desai@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Roopa Desai |
| Designation |
Associate Professor |
| Affiliation |
Dr.D.Y.Patil College of Physiotherapy |
| Address |
Dr.D.Y.Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9890992383 |
| Fax |
|
| Email |
roopa.desai@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrManisha Rathi |
| Designation |
Professor |
| Affiliation |
Dr.D.Y.Patil College of Physiotherapy,Pune |
| Address |
Dr.D.Y.Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850418712 |
| Fax |
|
| Email |
manisha.rathi@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil Vidyapeeth,Pune.Dr.D.Y.Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune-411018 |
|
|
Primary Sponsor
|
| Name |
Roopa Desai |
| Address |
Dr.D.Y.Patil Vidyapeeth Pune.Dr.D.Y.Patil College of Physiotherapy,Pimpri,Pune-411018 |
| 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 |
| Roopa Desai |
Dr.D.Y.Patil College of Physiotherapy,Pimpri,Pune |
Physiotherapy OPD,Basement.
Pune
MAHARASHTRA |
9890992383
roopa.desai@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE Dr.D.Y.Patil VIDYAPEETH, PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Combination of kinetic Control and Lumbar Stabilization Exercises. |
Participants will be treated with a Combination of Kinetic Control and Lumbar Stabilization Exercises,3 sessions per week for a period of 8 weeks. |
| Intervention |
Kinetic Control |
Participants will be treated with Kinetic Control,3 sessions per week for a period of 8 weeks. |
| Comparator Agent |
Lumbar Stabilization Exercises |
participants will be treated with Lumbar Stabilization Exercises,3 sessions per week for a period of 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with Chronic Mechanical Low Back Pain,subjects with mild to moderate pain on NPRS,Age group between 20 to 40 years,both genders. |
|
| ExclusionCriteria |
| Details |
History of Spine Surgery,Recent Lower Limb Surgery,Recent Trauma to Back and Lower Extremities,diagnosed pathological conditions related to Low Back Pain,diagnosed cases of Rheumatoid Arthritis,Ankylosing Spondylitis,Spinal deformities,Neurological diseases,History of Cardiovascular diseases,Stroke,Pregnancy,history of radiating pain to Lower Extremities,BMI more than 30kgs per m2,Subjects taking any other forms of treatment for Low Back Pain. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessing Lumbar Core Strength by Pressure Biofeedback.
2.Activation of Transversus Abdominis and Multifidus by EMG. |
1.Assessing Lumbar Core Strength by Pressure Biofeedback after 4 and 8 weeks.
2.Activation of Transversus Abdominis and Multifidus by EMG after 4 and 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Numerical Pain Rating Scale(NPRS)
2.Modified-Modified Schobers Test . |
1.NPRS from 1 to 10 after 4 and 8 weeks.
2.Modified Modified Schobers Test should be between 8-10cms after 4 and 8 weeks. |
| Rolland Morris Disability Questionnaire |
It has 24 Questions that focus on regular activities of daily living that will be assessed after 4 and 8 weeks. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/06/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Effects of Movement Retraining and Lumbar
Stabilization Exercises in Mechanical Low Back
Pain: A Pilot Study.
2. Can Lumbar Stabilization Exercises influence synergy pattern and Recruitment time of core muscles in Chronic Mechanical Low Back Pain? Pre-Post Experimental Study.- Accepted |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is an experimental,single blinded,parallel group study comparing the effect of Kinetic Control,Lumbar Stabilization Exercises and a combination of Kinetic Control and Lumbar Stabilization Exercises on pain,flexibility,Strength,muscle Activation and functional disability in subjects with Mechanical Low Back Pain.The study will be conducted in Dr.D.Y. Patil Physiotherapy Out Patient Department Pune ,India. The Primary Outcome measures will be Pressure Biofeedback to assess core muscle strength and Activation of Transversus Abdominis and Multifidus by EMG.The secondary Outcome measures include Pain that will be measured by NPRS , Lumbar Range of Motion measured by Modified Modified Schobers test and Rolland Morris Disability Questionnaire,that consists of 24 Questions that focus on regular activities of daily living.All outcome measures will be assessed prior to the treatment,at the end of 4th week and at the end of 8th week.
1. August 2020 - Conducted Pilot Study and calculated sample size taking 10% dropout rates that came upto 75 patients. 2. Completed SWAYAM MOOC Course on Academic Writing 11th January 2021 to 25th April 2021. 3. May 2021 - Data Collection in process 4. November 2021 - Data collection in process
|