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Comparative Effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in Patients With Chronic Low Back Pain

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Routine Physical Therapy
Muscle Energy Technique
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Low back pain, Lumbar pain, Backache, Muscle Energy Technique, Quadratus Lumborum

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Lahore teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine Physical Therapy group

Experimental group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain will be assessed by Numeric pain rating scale
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.
Range of Motion will be assessed by Universal Goniometer
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.
Quality of life will be assessed by Medical outcomes study: 20 item Short form survey instrument
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.
Functional Disability will be assessed by Oswestry Low Back Pain Disability Index
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.

Secondary Outcome Measures

Full Information

First Posted
December 13, 2021
Last Updated
August 30, 2022
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05174520
Brief Title
Comparative Effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in Patients With Chronic Low Back Pain
Official Title
Comparative Effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
•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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Low back pain, Lumbar pain, Backache, Muscle Energy Technique, Quadratus Lumborum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine Physical Therapy group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Physical Therapy
Other Intervention Name(s)
Conventional Physical Therapy
Intervention Description
Routine physical therapy will be provided to group A for 25 minutes thrice a week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Muscle Energy Technique
Intervention Description
Muscle Energy technique along with Routine physical therapy will be provided to group B for40 minutes thrice a week for 4 weeks.
Primary Outcome Measure Information:
Title
Pain will be assessed by Numeric pain rating scale
Description
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.
Time Frame
1 minute
Title
Range of Motion will be assessed by Universal Goniometer
Description
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.
Time Frame
2 minutes
Title
Quality of life will be assessed by Medical outcomes study: 20 item Short form survey instrument
Description
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.
Time Frame
8 minutes
Title
Functional Disability will be assessed by Oswestry Low Back Pain Disability Index
Description
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.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Waqar Afzal, Mphil-MSK
Organizational Affiliation
University of Lahore
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Syed Asadullah Arslan, Ph.D. PT
Organizational Affiliation
University of Lahore
Official's Role
Study Director
Facility Information:
Facility Name
University of Lahore teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
53700
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in Patients With Chronic Low Back Pain

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