| CTRI Number |
CTRI/2025/01/079120 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| 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
|
Muscle Energy Technique helps improve flexibility, while Lumbar Stabilization Exercise strengthens core muscles, both reducing pain in mechanical low back pain |
|
Scientific Title of Study
|
Effect of Muscle Energy Technique versus Lumbar Stabilization Exercise Program in Individuals 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 |
Pooja Kumari |
| Designation |
MPT Scholar |
| Affiliation |
GD Goenka University |
| Address |
ROOM NO 421 A Physiotherapy department GD Goenka University Sohna Gurugram Haryana
Gurgaon
HARYANA
122103
India |
| Phone |
9888298735 |
| Fax |
|
| Email |
poojapoonia09jan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat Bhushan |
| Designation |
Professor & Head of clinicals |
| Affiliation |
GD Goenka University |
| Address |
Room No 421 A Physiotherapy Department GD Goenka University Sohna Gurugram Haryana India 12203
Gurgaon
HARYANA
122103
India |
| Phone |
9729021111 |
| Fax |
|
| Email |
bharat.bhushan1@gdgu.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwajeet Trivedi |
| Designation |
Associate professor |
| Affiliation |
GD Goenka University |
| Address |
Room No 421 A physiotherapy Department GD Goenka University Sohna Gurgaon Haryana 122103
Gurgaon
HARYANA
122103
India |
| Phone |
9779046672 |
| Fax |
|
| Email |
vishwajeet.trivedi@gdgu.org |
|
|
Source of Monetary or Material Support
|
| Room No 421 A Physiotherapy Department GD Goenka University Sohna Gurugram Haryana India 122103 |
|
|
Primary Sponsor
|
| Name |
Pooja Kumari |
| Address |
Room No 421 A Physiotherapy Department GD Goenka University Sohna Gurugram Haryana India 122103 |
| 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 |
| DrPooja Kumari |
GD Goenka University |
Physiotherapy OPD-1 GD Goenka University Sohna Gurugram Haryana 122103
Gurgaon
HARYANA |
9888298735
poojapoonia09jan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WavesWomenEmpowermentTrust |
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 |
| Comparator Agent |
Ergonomics Advice + moist heat pack |
3 session per week for 4 weeks |
| Intervention |
Lumber Stabilization Exercises Program |
3 Session per week for 4 weeks |
| Intervention |
Muscle Energy Technique |
3 session per week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged 20- 50 years
Both gender male and female
Without radiating to buttocks , thigh or leg pain and having Oswestery disability score of below 6.
Provide informed consent and will be willing to participate the study .
|
|
| ExclusionCriteria |
| Details |
Pathological back pain (fracture, osteoporosis )
Any subjects with Paraesthesia or numbness into the lower extremities
Any surgical history on spine
Pregnancy
Any history of cancer
Any congenital structural deformity ( scoliosis , kyphosis )
Any neurological disorder (Cerebral Palsy, epilepsy like etc. )
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oswestry Disability Index
|
At Baseline for 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
visual analog scale
Short Form Health Survey |
First week( Preintervention)
Fourth week ( Preintervention) |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/02/2025 |
| 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="1"
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
|
Summary of protocol This study involves randomized intervention targeting mechanical low back pain with 72 participant divided into three groups :muscle energy technique with moist heat pack(Group A)lumber stabilization exercise with moist heat pack (Group B) and ergonomics advice o moist heat pack only (Group C)pre and post intervention assessment will occur over 4 weeks.
Interventions Group A: In the group A subject were given moist heat pack and MET. MET for the erector spinae , Quadratus lumborum, emphasizing isometrics contraction and guided stretching with relaxation performed 3 times weekly. Group B: Moist heat pack with lumber stabilization exercise focusing on erector spinae , Quadratus lumborum ,multifidus and transverse abdominis performed 3 times weekly. Group C : Ergonomics advice and moist heat pack 3 times weekly.
Assessment and analysis : pain level are elevated before and after 4 weeks of intervention . data analysis will follow the intervention period to assess effectiveness. |