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

NCT05939024 | Completed

• 1 other identifier: Rashid
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Mechanical

Keywords

Muscle Energy Technique; Physical Therapy; Pain; Functional Disability; Fear Avoidance Beliefs; Quality of Life; Range of Motion

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (2)

Conventional Physical Therapy (CPT) Group

ACTIVE COMPARATOR

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

Other: Conventional Physical Therapy

Muscle Energy Technique plus Conventional Physical Therapy Group

EXPERIMENTAL

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

Interventions

Muscle Energy Technique plus Conventional Physical Therapy OTHER

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.

Also known as: Post-Isometric Relaxation Technique plus Conventional Physical Therapy

Muscle Energy Technique plus Conventional Physical Therapy Group

Conventional Physical Therapy OTHER

Conventional Physical Therapy consists of hot pack, TENS, Ultrasonic along with stretching and exercises of back musculature.

Conventional Physical Therapy (CPT) Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Dr Ashfaq Ahmed, PhD

  University of Lahore

  STUDY CHAIR

• Rashid Hafeez Nasir, M. Phil

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be unaware of the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 11, 2023
• Study Start: February 1, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 31, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately after publication
• Access Criteria: Researchers who provide methodological sound proposal

Locations

PA (1)