search
Back to results

Efficacy of Muscle Energy Techniques in the Treatment of Chronic Non-specific Low Back Pain

Primary Purpose

Low Back Pain, Mechanical

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

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring Muscle Energy Technique, Physical Therapy, Pain, Functional Disability, Fear Avoidance Beliefs, Quality of Life, Range of Motion

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 18 - 45 years Gender : both genders Low Back Pain of more than 3 months duration ODI Score between 20-80% BMI: 25-29 Kg/m2 VAS: Initial Pain Score > 3 Pain Localized to Lower Lumbar Region Decreased Lumbar ROM Exclusion Criteria: Red Flag Signs of Low Back Pain (Metabolic Bone Disease, Malignancy, Cardiovascular Disorder, Pregnancy) Patient with Paraesthesia or Numbness Disturbed Reflexes (Hypo/Hyper Reflexia) Motor Weakness H/O Low Back Surgery H/O Recent Trauma < 2 Months H/O Rheumatoid Arthritis, Osteoporosis and Fracture Joint hyper mobility. Psychological Mental Disorders

Sites / Locations

  • The University of Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Physical Therapy (CPT) Group

Muscle Energy Technique plus Conventional Physical Therapy Group

Arm Description

Patients in this group will receive Conventional Physical therapy only, which includes hot pack, TENS, Ultrasonic, stretching and strengthening exercises.

In this group, Post Isometric Relaxation of the Muscle Energy Techniques will be applied to the Spinal Stabilizers and Mechanoreceptors in addition to Conventional Physical Therapy.

Outcomes

Primary Outcome Measures

Pain Intensity
Pain intensity will be measured using Visual Analogue Scale. It consists of a 10cm line, with two end points, 0 representing no pain and 10 representing pain as bad as it could be possible.
Lumbar Ranges of Motion
Lumbar Ranges of Motion will be measured using inclinometer. The normal amount of lumbar flexion range of motion is 60 degrees, and the normal range of motion of lumbar extension is 25 degrees. The lumbar spine also normally moves 25 degrees in lateral flexion, or side bending.
Functional Disability Level
Oswestry Disability Index was used to determine the functional status of individual. The final score ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Change in Fear Avoidance Belief
Fear Avoidance Beliefs will be observed using Fear Avoidance Beliefs Questionnaire. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
Change in Quality of Life
Short Form-36 Health Survey Questionnaire was used to measure change in Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Total score of this questionnaire is 100, with lower the score the more disability, the higher the score the less disability.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2023
Last Updated
August 15, 2023
Sponsor
University of Lahore
search

1. Study Identification

Unique Protocol Identification Number
NCT05939024
Brief Title
Efficacy of Muscle Energy Techniques in the Treatment of Chronic Non-specific Low Back Pain
Official Title
Efficacy of Conventional Physical Therapy With and Without Muscle Energy Techniques in the Treatment of Chronic Non-Specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
July 31, 2023 (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
No

5. Study Description

Brief Summary
Chronic Non-Specific Low Back Pain is characterized as a tension, soreness and stiffness. Various studies, defined MET as a manual medicine treatment procedure that involves the voluntary contraction of the subject's muscle in a precisely controlled direction, at varying levels of intensity, against a distinctly executed counterforce applied by the therapist.
Detailed Description
Chronic Non-specific LBP is located in region below lower costal margins and above inferior gluteal margins with or without any referred pain in legs, an essentially non-attributable to any specific cause. It may lasting for more than 7-12 months and affect individual over a long period of time once in a lifetime at least. METs is useful in increasing extensibility and range of motion of various joints and provides good results in the patients with back pain. These techniques are used as the treatment of weakened muscles, restricted joints, reducing pain reliving muscle tension & spasm, & increased strength of the muscle. MET is a verstile, safe, gentle technique traditionally used to address muscular strain, PAIN, local edema and joint dysfunction. It was reported that post isometric relaxation is considered a highly effective therapy for back dysfunction patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
Keywords
Muscle Energy Technique, Physical Therapy, Pain, Functional Disability, Fear Avoidance Beliefs, Quality of Life, Range of Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be unaware of the treatment group.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physical Therapy (CPT) Group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive Conventional Physical therapy only, which includes hot pack, TENS, Ultrasonic, stretching and strengthening exercises.
Arm Title
Muscle Energy Technique plus Conventional Physical Therapy Group
Arm Type
Experimental
Arm Description
In this group, Post Isometric Relaxation of the Muscle Energy Techniques will be applied to the Spinal Stabilizers and Mechanoreceptors in addition to Conventional Physical Therapy.
Intervention Type
Other
Intervention Name(s)
Muscle Energy Technique plus Conventional Physical Therapy
Other Intervention Name(s)
Post-Isometric Relaxation Technique plus Conventional Physical Therapy
Intervention Description
Post-Isometric Relaxation of the Muscle Energy Techniques will be applied to Spinal Stabilizers and Mechanoreceptors. Hold time will be 7 seconds with 5 seconds rest between two performance x 3 times /session. Whereas, Conventional Physical Therapy consists of hot pack, TENS, Ultrasonic along with stretching and exercises of back musculature.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
Conventional Physical Therapy consists of hot pack, TENS, Ultrasonic along with stretching and exercises of back musculature.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity will be measured using Visual Analogue Scale. It consists of a 10cm line, with two end points, 0 representing no pain and 10 representing pain as bad as it could be possible.
Time Frame
Pain intensity will be measured at the baseline at the time of recruitment, and change in pain intensity will be measured at 2nd week and 3rd week of intervention.
Title
Lumbar Ranges of Motion
Description
Lumbar Ranges of Motion will be measured using inclinometer. The normal amount of lumbar flexion range of motion is 60 degrees, and the normal range of motion of lumbar extension is 25 degrees. The lumbar spine also normally moves 25 degrees in lateral flexion, or side bending.
Time Frame
Lumbar Range of Motion will be measured at baseline at the time of recruitment and change in range of motion will be measured at 2nd week and 3rd week of treatment.
Title
Functional Disability Level
Description
Oswestry Disability Index was used to determine the functional status of individual. The final score ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Time Frame
Level of Functional Disability will be recorded as baseline at the time of recruitment and change in functional status will be observed at the 2nd week and 3rd week of intervention.
Title
Change in Fear Avoidance Belief
Description
Fear Avoidance Beliefs will be observed using Fear Avoidance Beliefs Questionnaire. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
Time Frame
Fear Avoidance Beliefs will be observed as baseline at the time of recruitment and any change in Fear Avoidance Beliefs will be observed at the 2nd week and 3rd week of treatment.
Title
Change in Quality of Life
Description
Short Form-36 Health Survey Questionnaire was used to measure change in Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Total score of this questionnaire is 100, with lower the score the more disability, the higher the score the less disability.
Time Frame
Change in quality of life will be measured at baseline at the time of recruitment and change in quality of life will be measured at the 2nd week and 3rd week of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18 - 45 years Gender : both genders Low Back Pain of more than 3 months duration ODI Score between 20-80% BMI: 25-29 Kg/m2 VAS: Initial Pain Score > 3 Pain Localized to Lower Lumbar Region Decreased Lumbar ROM Exclusion Criteria: Red Flag Signs of Low Back Pain (Metabolic Bone Disease, Malignancy, Cardiovascular Disorder, Pregnancy) Patient with Paraesthesia or Numbness Disturbed Reflexes (Hypo/Hyper Reflexia) Motor Weakness H/O Low Back Surgery H/O Recent Trauma < 2 Months H/O Rheumatoid Arthritis, Osteoporosis and Fracture Joint hyper mobility. Psychological Mental Disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr Ashfaq Ahmed, PhD
Organizational Affiliation
The University of Lahore
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rashid Hafeez Nasir, M. Phil
Organizational Affiliation
The University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participants data that underlies the results after de-identification
IPD Sharing Time Frame
Immediately after publication
IPD Sharing Access Criteria
Researchers who provide methodological sound proposal

Learn more about this trial

Efficacy of Muscle Energy Techniques in the Treatment of Chronic Non-specific Low Back Pain

We'll reach out to this number within 24 hrs