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

August 15, 2023 updated by: Ayesha Jamil, University of Lahore

Efficacy of Conventional Physical Therapy With and Without Muscle Energy Techniques in the Treatment of Chronic Non-Specific Low Back Pain

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • The University of Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age: 18 - 45 years
  2. Gender : both genders
  3. Low Back Pain of more than 3 months duration
  4. ODI Score between 20-80%
  5. BMI: 25-29 Kg/m2
  6. VAS: Initial Pain Score > 3
  7. Pain Localized to Lower Lumbar Region
  8. Decreased Lumbar ROM

Exclusion Criteria:

  1. Red Flag Signs of Low Back Pain (Metabolic Bone Disease, Malignancy, Cardiovascular Disorder, Pregnancy)
  2. Patient with Paraesthesia or Numbness
  3. Disturbed Reflexes (Hypo/Hyper Reflexia)
  4. Motor Weakness
  5. H/O Low Back Surgery
  6. H/O Recent Trauma < 2 Months
  7. H/O Rheumatoid Arthritis, Osteoporosis and Fracture
  8. Joint hyper mobility.
  9. Psychological Mental Disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional Physical Therapy (CPT) Group
Patients in this group will receive Conventional Physical therapy only, which includes hot pack, TENS, Ultrasonic, stretching and strengthening exercises.
Other: Conventional Physical Therapy
Conventional Physical Therapy consists of hot pack, TENS, Ultrasonic along with stretching and exercises of back musculature.
Experimental: Muscle Energy Technique plus Conventional Physical Therapy Group
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.
Other: Muscle Energy Technique plus Conventional Physical Therapy
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.
Other Names:
  • Post-Isometric Relaxation Technique plus Conventional Physical Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity
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.
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.
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.
Lumbar Ranges of Motion
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.
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.
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.
Functional Disability Level
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.
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.
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.
Change in Fear Avoidance Belief
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.
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.
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.
Change in Quality of Life
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Lahore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Prof. Dr Ashfaq Ahmed, PhD, The University of Lahore
  • Principal Investigator: Rashid Hafeez Nasir, M. Phil, The University of Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Rashid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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