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Completed

NCT Number: NCT05840666

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

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

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Key information

Conditions

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

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

A variety of treatment interventions, modalities and techniques are used in physical therapy management of non-specific low back pain including manual therapy, exercises, neural mobilizations, stretching soft tissue techniques and dry needling etc. Out of these more recent literature supports manual therapy, self exercises, patient counseling and awareness have been recommended in back pain management guidelines, in the United States and is also frequently used in clinical practice in various countries.

Despite multiple theoretical frame works proposing the role of SNAGs and MDT mobilizations and exercises respectively, the literature on the true mechanism of direct or indirect physiological effects of these on performance or performance-related outcomes is vague and lacks justifiable procedural rigor.

The results of this study will provide information regarding the direction for practitioners in choosing the manual therapy or repeated exercises as effective prescription and provide a basis for future research.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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.

Treatment and study plan

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).

Other names: Mulligan Mobilization

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.

Other names: Mechanical Diagnosis and Therapy (MDT)

Conventional physical therapy

Other

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

Primary outcomes

  1. Pain Intensity

    Time frame: 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.

    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

  2. Lumbar Range of Motion

    Time frame: 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.

    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

  3. Level of Functional Disability

    Time frame: 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.

    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.

  4. Change in 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 end of 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.

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

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Ayesha Jamil

Other

Registry information

Official study title

Effects of Mulligan Sustained Natural Apophyseal Glides Versus McKenzie Method of Mechanical Diagnosis & Therapy in Patients With Non-Specific Chronic Low Back Pain

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 3, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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