| CTRI Number |
CTRI/2025/02/081246 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparative Study of Muscle Energy Technique for Quadratus lumborum and Erector Spinae in Acute Low Back Pain |
|
Scientific Title of Study
|
A Comparative Study between the Muscle Energy Technique of Quadratus lumborum and Erector Spinae Muscles in young Adults with Acute Non-Specific 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 |
Sahil Pawaria |
| Designation |
Mpt Orthopedics Student |
| Affiliation |
Guru Nanak Dev University, Grand Trunk Road, Off NH 1, Amritsar, Punjab-143005, India |
| Address |
Ground Floor, Department of Physiotherapy, Guru Nanak Dev University, Grand Trunk Road, Off NH 1,
Amritsar, Punjab-143005, India
Amritsar
PUNJAB
143005
India |
| Phone |
9717768727 |
| Fax |
|
| Email |
sahilsinghpawaria1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manpreet Bir Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University, Grand Trunk Road, Off NH 1, Amritsar, Punjab-143005, India |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Grand Trunk Road, Off NH1, Amritsar, Punjab-143005, India
Amritsar
PUNJAB
143005
India |
| Phone |
9988333506 |
| Fax |
|
| Email |
manpreet.physio@gndu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Manpreet Bir Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University, Grand Trunk Road, Off NH 1, Amritsar, Punjab-143005, India |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Grand Trunk Road, Off NH1, Amritsar, Punjab-143005, India
Amritsar
PUNJAB
143005
India |
| Phone |
9988333506 |
| Fax |
|
| Email |
manpreet.physio@gndu.ac.in |
|
|
Source of Monetary or Material Support
|
| University Health Center, Physiotherapy Center, Ground Floor, Guru Nanak Dev University, Grand Trunk Road, Off NH 1, Amritsar, Punjab-143005 |
|
|
Primary Sponsor
|
| Name |
Sahil Pawaria |
| Address |
Ground Floor, Department of Physiotherapy, Guru Nanak Dev University, Grand Trunk Road, Off NH 1,
Amritsar, Punjab-143005, |
| 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 |
| Sahil Pawaria |
University Health Center, Physiotherapy Center |
Ground Floor, Guru Nanak Dev University, Grand Trunk Road, Off NH 1, Amritsar, Punjab-143005
Amritsar
PUNJAB |
9717768727
sahilsinghpawaria1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Guru Nanak Dev University Amritsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non Specific Low Back Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muscle Energy Technique |
MET is a manual therapy that uses a patients active muscle contractions against controlled resistance to improve mobility, reduce pain and restore musculoskeletal function.
Frequency: 2 session per week
Duration: 10 second contraction, 5 second rest period with 5 repetitions in each session |
| Comparator Agent |
Quadratus lumborum Muscle and Erector Spinae Muscle |
Muscle Energy Technique of Quadratus Lumborum and Muscle Energy technique of Erector Spinae.
Frequency: 2 session per week
Duration: 10 second contraction , 5 second rest period with 5 repetitions in each session |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Subjects between Age groups of 18 – 35 years.
Both Males and Females subjects will be taken.
Subjects with cases of Non specific Low Back pain localized Paraspinal with Quadratus Lumborum and erector Spinae Tightness.
Subjects with history of lumbar or lumbosacral pain without proximal radicular pain will be taken. |
|
| ExclusionCriteria |
| Details |
Subjects with history of Disc Bulge, Spondylolisthesis, Spinal Stenosis, Spondylosis,
Osteoporosis.
Subjects with Neurological Symptoms like Radicular symptoms, Cauda Equina Syndrome.
Subjects with history of Infection and Tuberculosis.
Subjects with Inflammatory Conditions like Ankylosing Spondylitis, Rheumatoid Arthritis. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Non Specific Low Back Pain |
Baseline and after Intervention 1 on day 1 and day 4 in week 1
washout period in week 2
Intervention 2 on day 1 and day 4 in week 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of Motion, Functional Disability |
Baseline & post-intervention 1 on day 1 & day 4 of week 1, followed by a washout period during week 2 then Intervention 2 on day 1 & day 4 of week 3 |
|
|
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)
|
12/03/2025 |
| 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="0"
Days="30" |
|
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
|
PURPOSE OF STUDY: The Quadratus Lumborum (QL) and Erector spinae (ES) muscles are highly affected in treating Non-Specific Low Back Pain (NSLBP). Isolated Muscle Energy Technique (MET) of these two muscles has shown good results in treatment but to the best of my knowledge there is no study which compares the effectiveness of QL MET and ES MET in treating Acute non-specific low back pain. Thus, this gap highlights the need of research to identify which specific Met (QL or ES) is more effective. Consequently, this study was motivated by the desire to evaluate and compare the efficacy of different isolated muscle met approaches for treating non-specific low back pain.
AIM OF THE STUDY: The Aim of the study is a comparative analysis between the Muscle Energy techniques of Quadratus Lumborum and Erector Spinae muscles in Young Adults with Acute Non-Specific Low Back Pain.
OBJECTIVES: 1. To check the effect of MET on pain by using NPRS Scale. 2. To measure Lumbar Range of motion (ROM) by using Modified Schober Test. 3. To assess the subjective experience of pain by evaluating its sensory, affective, and evaluative components using the McGill Pain Questionnaire. 4. To assess disability caused by low back pain, focusing on how pain affects daily physical activities and function by using Roland Morris Disability Questionnaire. 5. To measure and compare muscle tightness and flexibility in individuals by using MET for QL and ES muscles.
HYPOTHESIS: ALTERNATE HYPOTHESIS [H1]: MET of Quadratus lumborum would have significant improvement on pain, range of motion or functional disability then MET of Erector Spinae. MET of Erector Spinae would have significant improvement on pain, range of motion or functional disability then MET of Quadratus Lumborum. NULL HYPOTHESIS [H0]: There will be no significant improvement on pain, range of motion or function disability in Met of Quadratus Lumborum Muscle. There will be no significant improvement on pain, range of motion or function disability in Met of Erector Spinae Muscle.
METHOD FOR DATA COLLECTION: Random Stratified sampling will be performed. Informed written consent will be taken from subjects prior to participation in study. Then on the basis of orthopaedic assessment which will be done by Subject expert. Allocation of subjects will be done randomly in two groups on the basis of inclusion and exclusion criteria. Subjects will be divided into GROUP-1 and GROUP-2. The data will be collected under natural environmental conditions while maintaining the privacy of subjects. |