Mulligan Sustained Natural Apophyseal Glides Versus McKenzie Method in Patients With Non-Specific Chronic Low Back Pain

NCT05840666 | Completed

• 1 other identifier: Ahsan Javed
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain (LBP) is the most frequent complaint encountered in clinical practice. Exercises and manual therapy prescription are common physical therapy treatments prescribed for the patients presenting with chronic low back pain. The interventions will establish the future direction for practitioners in choosing the manual therapy or repeated exercises as effective prescription and provide a basis for future research

Conditions

Low Back Pain

Keywords

Non-specific Low Back Pain; Sustained Natural Apophyseal Glide; McKenzie Method; Mechanical Diagnosis and Therapy; Range of Motion; Pain; Functional Disability; Fear Avoidance Beliefs

Outcome Measures

Primary Outcomes (5)

• Pain Intensity

  Level of pain intensity will be measured using Numeric Rating Scale. The 11-point numeric scale ranges from '0' representing no pain to '10' representing the extreme pain

  Pain intensity will be recorded as baseline at the time of recruitment and change in pain intensity will be observed at follow up at the end of 3rd week of treatment.

• Lumbar Range of Motion

  Lumbar Range of motion will be measured using inclinometers. Normal lumbar range of motion include 60 degrees of flexion, 25 degrees of extension, and 25 degrees of lateral bending

  Lumbar Range of Motion will be observed as baseline at the time of recruitment and change in ROM will be observed at follow up at end of 3rd week of treatment.

• Level of Functional Disability

  Functional Disability will be measured with the Modified Low Back Pain Disability Questionnaire. The scores range from 0-100% with lower scores meaning less disability.

  Functional Disability will be recorded as baseline at the time of recruitment and change in score of functional disability will be recorded at the end of 3rd week of treatment.

• Change in Fear Avoidance Beliefs

  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 end of 3rd week of treatment.

• Change in Muscle Activation of Lumbar Multifidus (LM) and Transversus Abdominis (TrA)

  Muscle Activation of Lumbar Multifidus (LM) and Transversus Abdominis (TrA) will be measured with Rehabilitative Ultrasound Imaging (RUSI).The activation of muscle is represented through change in thickness level of muscle observed through RUSI. The normal thickness of TrA is 3.93mm and LM is 28.99mm.

  The Thickness of muscles will be recorded as baseline at the time of recruitment and change in thickness representing activation will be measured at follow up at the end of 3rd week of treatment.

Study Arms (3)

Conventional Physical Therapy (CPT) Group

ACTIVE COMPARATOR

Conventional Physical Therapy will consist of Therapeutic Ultrasound, Moist Heat-pack, TENS and standard exercises. Participants will receive 15 sessions of Conventional Physical Therapy (CPT) at a frequency of 5 sessions per week.

Other: Conventional Physical Therapy

Conventional Physical Therapy (CPT) plus Mulligan SNAGs Group

EXPERIMENTAL

Besides Conventional Physical Therapy, Mulligan Mobilizations will be provided in this group. It consist of Extension SNAGS in prone, and Lumbar flexion SNAGS in sitting. The techniques will be applied in 3 sets with 10 repetitions and 60 seconds rest between sets.

Other: Mulligan Sustained Natural Apophyseal Glide (SNAG)

Conventional Physical Therapy plus McKenzie MDT Group

EXPERIMENTAL

Along with Conventional Physical Therapy, McKenzie MDT will be be given in this group. It consist of Prone lying, Prone lying Elbow popups, Prone elbow Extension. Standing Extension, supine Both Knee to Chest, Sitting on chair with forward flexion. The techniques will be applied in 3 sets with 8-10 repetitions and 60 seconds rest between sets.

Other: McKenzie Method

Interventions

Mulligan Sustained Natural Apophyseal Glide (SNAG) OTHER

Application of the MWM technique developed by Brian R. Mulligan. The clinical researcher will perform and holds sustained passive segmental glide at the target joint maintaining the slack whereas the patient will actively move in the direction of pain or stiffness. These MWM techniques when applied to spinal segments or joint is called sustained natural apophyseal glide (SNAG).

Also known as: Mulligan Mobilization

Conventional Physical Therapy (CPT) plus Mulligan SNAGs Group

McKenzie Method OTHER

An active therapy technique involving repeated movements or sustained positions along with an educational component prescribed to the patient for of minimizing the pain and disability and increase the spinal range of motion. The method will involve the assessment of symptomatic and mechanical responses to repeated movements and sustained positions in the direction of preference. The method will be used for assessment and treatment of patients and with derangement syndrome.

Also known as: Mechanical Diagnosis and Therapy (MDT)

Conventional Physical Therapy plus McKenzie MDT Group

Conventional Physical Therapy OTHER

It includes usual physical therapy care such as Therapeutic Ultrasound, Moist Heat-pack, TENS and standard exercises.

Conventional Physical Therapy (CPT) Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of Both genders
• Adult patents between the 20 to 45 years of age with chronic non-specific low back pain.
• Pain intensity of at least 3 or greater on 0-10 Numeric Rating Scale.
• Modified Low Back Pain Disability Questionnaire score equal to or greater than 20%.

You may not qualify if:

• Serious underlying pathology with red flags.
• Patients having contraindication to physical exercises.
• Females with high parity.
• Pregnant or lactating females.
• Patients who participated in any type of rehabilitative training or exercise program for back pain in last 1 month.
• Spinal deformity or Spinal stenosis.
• History of fall or trauma to spine in last one year.
• History of spinal, abdominal or hip surgery.
• Signs of nerve root compression with sensory, motor or deep tendon reflexes deficit.
• Serious underlying pathology with red flags.
• Systemic disease e.g., cardiovascular, metabolic or central nervous system.
• Osteopenia, osteoporosis.
• Medication's history (steroids, immunosuppressants, chemotherapy)
• Limb length discrepancy.

Sponsors & Collaborators

• Ayesha Jamil: lead

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

Therapeutics

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

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 of study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized to three study arms and each study arm will be allocated a different intervention

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 3, 2023
• Study Start: January 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 15, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

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)