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

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: Completed
• Conditions: Low Back Pain, Mechanical
• Intervention / Treatment: Other: Conventional Physical Therapy; Other: Muscle Energy Technique plus Conventional Physical Therapy

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: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	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

• Sponsor: University of Lahore
• Investigators: 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

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Pain; Physical Therapy; Range of Motion; Muscle Energy Technique; Functional Disability; Fear Avoidance Beliefs
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID 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