- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05174520
Comparative Effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in Patients With Chronic Low Back Pain
Comparative Effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
•Null hypothesis: There is no difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.
•Alternative hypothesis: There is difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the study is to compare the effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain on Pain, Range of Motion, Quality of Life and Functional Disability.
The study procedure will be explained to the patients and informed written consent will be obtained from those patients who will be willing to participate in the study. Quadratus Lumborum tightness will be assessed using side bending test.
Those fulfilling the requirement of inclusion criteria will be indiscriminately separated into 2 groups. NPRS, Oswestry Disability Index, SF-20 and goniometer will be used to collect data.
Total 68 participants will be recruited in the study. Routine Physical therapy will be provided to group A. Reciprocal inhibition Muscle Energy Technique on quadratus lumborum along with Routine Physical Therapy will be performed on group B.
Both group will receive interventions three sessions in a week for 4 consecutive weeks.
Assessment of Pain, Range of motion, Quality of Life and Functional Disability will be assessed by using goniometer, NPRS, Oswestry Disability Index and SF-20 Questionnaire respectively for both groups at the baseline, end of 6th session (2nd week) and end of 12th session (4th week) and follow up will be obtained after 1 month (8th week).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 53700
- University of Lahore Teaching Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Both genders of age 30 to 55 year.
- Patients with pain for at least three months or more (chronic stage).
- Patients having score of at least 3 on 0-10 points(NPRS).
- Diagnosed patients of low back pain.
- Non-radicular low back pain.
- Quadratus Lumborum tightness by physical test i.e. side bending test.
Exclusion Criteria:
- Pregnant females.
- Lumbar radiculopathy.
- Any spinal pathology i.e. infectious disease and fracture.
- Any congenital deformity of spine, upper and lower extremities.
- Systemic illnesses i.e. cardiovascular disorders, respiratory disorders etc.
- History of surgery of hip, pelvis, lumbar spine, disc herniation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Routine Physical Therapy group
Routine physical therapy group includes thermotherapy for 10 mins, transcutaneous electrical nerve stimulations for 10 mins. Exercises such as: Pelvic tilts, bridging exercise, William flexion exercises and stretching will be performed for 7-10 repetitions. Treatment duration will be 25 minutes. |
Routine physical therapy will be provided to group A for 25 minutes thrice a week for 4 weeks.
Other Names:
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|
Experimental: Experimental group
Experimental group includes 6-7 repetitions of Muscle energy technique on Quadratus Lumborum muscle and Routine physical therapy, i.e Thermotherapy, transcutaneous electrical nerve stimulations, Pelvic tilts, bridging exercise, William flexion exercises and stretching will be performed for 7-10 repetitions. Treatment duration will be 40 minutes. |
Muscle Energy technique along with Routine physical therapy will be provided to group B for40 minutes thrice a week for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain will be assessed by Numeric pain rating scale
Time Frame: 1 minute
|
Pain will be measured using 11 point Numeric Pain rating scale (NPRS).
0 score represents no pain, 1-3 score represents mild pain, 4-6 represents moderate pain and 7-10 represents severe pain.
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1 minute
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Range of Motion will be assessed by Universal Goniometer
Time Frame: 2 minutes
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Lumbar flexion, extension and side bending range of motion will be measured using Universal Goniometer.
Normal lumbar flexion range is 60 degrees, extension range is 25 degrees, and right and left side bending range is 25 degrees.
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2 minutes
|
|
Quality of life will be assessed by Medical outcomes study: 20 item Short form survey instrument
Time Frame: 8 minutes
|
The SF-20 measure contains three dimensions about function (physical, social and role) and well-being (mental health, health perception and pain).
score between 75- 100 leveled as good quality of life of low back pain patients, Average QOL marked when QOL score between 50-74, and QOL score between 0-49 leveled as poor QOL.
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8 minutes
|
|
Functional Disability will be assessed by Oswestry Low Back Pain Disability Index
Time Frame: 5 minutes
|
Oswestry disability index is a validated, 10-point patient-reported outcome questionnaire.
• 0% to 20% is scored as minimal disability.
• 21%-40% is scored as moderate disability.
• 41%-60% is scored as severe disability.
• 61%-80% is scored as crippled.
• 81%-100% scored as bedbound patients.
|
5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: M Waqar Afzal, Mphil-MSK, University of Lahore
- Study Director: Syed Asadullah Arslan, Ph.D. PT, University of Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSPTM02193012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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