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Clinical Trials/NCT04155450
NCT04155450CompletedNot Applicable

Effects of Extension Biased External Limb Loading in Addition to McKenzie Extension Protocol in Lumbar Derangement Syndrome

Foundation University Islamabad2 sites in 1 country30 target enrollmentStarted: November 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Postural Stability Index PSI will be assessed at the base line and at the end of 2 weeks session.

Study Overview

Brief Summary

Low back pain is one of the most common problem affecting one's daily living activities.

McKenzie Method of Mechanical Diagnostic Therapy (MDT) is an appealing modality of treatment. McKenzie classified the lumbar back pain into three categories i.e. lumbar postural syndrome, lumbar dysfunction syndrome and lumbar derangement syndrome.

Progressive extension bias limb loading exercises at lumbar region emphasizes on lumbar extensor musculature. The purpose of the current study is to determine the effects of extension biased lumbar limb loading exercises along with McKenzie extension protocols in the management of patients with lumbar derangement syndrome, which will also be a cost effective management option. It will also add to the existing pool of knowledge in the fields of conservative low back pain treatment, physical therapy, orthopedic manual therapy and musculoskeletal medicine.

Detailed Description

Low back pain is one of the most common problem affecting one's daily living activities.

Back pain results from multifactorial etiology with anatomical, psychological, physiological and social consequences and it is often classified as acute, sub-acute and chronic according to pain duration. Upto 71% of people with acute low back pain in primary care report persistent symptoms and therefore there is requirement for effective treatments in those who have not recovered after acute phase. Therapeutic exercises, manual therapy, functional training, modalities, traction, endurance training of back extensors, Kinesio-taping, trigger point therapy, deep friction massage are some of the procedures being safely and effectively applied by physical therapists to combat back discomfort or disorder.

McKenzie Method of Mechanical Diagnostic Therapy (MDT) approach was developed by Robin McKenzie who was a physical therapist from New Zealand back in 1950s. MDT is an appealing modality of treatment focusing on five areas of benefit-including reliable assessment, early prognosis, self-treatment, better outcomes and prevention of recurrence. The evaluation also determine who will get benefit from treatment and who will require another treatment protocols. McKenzie classified the lumbar back pain into three categories i.e. lumbar postural syndrome, lumbar dysfunction syndrome and lumbar derangement syndrome based on symptomatic or mechanical responses observed during repeated lumbar end range movements. The McKenzie Institute Lumbar Spine Assessment will be used to classify the patients into different syndromes and to choose the desired one fulfilling the inclusion criteria of study.

When normal tissues are deformed over a prolonged period it ends with postural syndrome like slouched posture and the postural syndrome may lead to dysfunction or derangement syndromes. Deformation of structures and tissues that causes pain at end ranges of available motion is characterized as dysfunction syndrome. Derangement syndrome is related to displacement of intervertebral disc with or without involvement of radiating pattern of pain along with back pain and fluctuations in symptoms or pain with directional movements can be observed due to force changes on affected intervertebral disc.

Centralizing and Peripherilizing are two important concepts with a strong association towards derangement syndrome. Centralizing reveals that movements or loading moves the most distal pain proximally while Peripherilizing shows movements or loading moves the pain more distally. McKenzie lumbar extension exercises results in reduction, abolition or centralization of symptoms. In Lumbar derangement syndromes following MDT classification system, a subgroup in which symptoms improve with lumbar extension is labeled as posterior derangement syndrome whereas the subgroup in which symptoms improve with lumbar flexion is labeled as anterior derangement syndrome. Work of many researchers, like Peterson, Machado and Paatelma, provided the strongest evidence regarding the validity of McKenzie method of treatment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Participant is unaware of the treatment group he is in.

Eligibility Criteria

Ages
30 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients of age 30 to 50 years
  • •Patients of both Gender i.e. Male & Female
  • •Lumbar Derangement Syndrome
  • •Centralization or Peripheralization phenomenon
  • •Constant or Intermittent pain worsening on repeated movements
  • •Somatic, radicular or combination of both patterns of pain
  • •Positive Radicular signs & symptoms

Exclusion Criteria

  • •Lumbar Postural syndrome
  • •Lumbar Dysfunction syndrome
  • •Post laminectomy/discectomy
  • •Spondylolisthesis
  • •Osteoporosis/Fractures
  • •Cauda equine syndrome
  • •Recent history of spinal trauma or surgery
  • •Lumbar myelopathy
  • •Patients with known metabolic diseases
  • •Participants having less than 20% ODI scoring

Arms & Interventions

McKenzie Extension with External Limb Loading Protocol

Experimental

Moist Heat Pack for 10 mins

McKenzie Extension Exercise Protocol

Static:

  1. Lying Prone
  2. Lying prone in extension
  3. Sustained extension
  4. Posture correction

Dynamic: 5. Extension in lying 6. Extension in lying with clinician overpressure 7. Extension mobilization 8. Extension in standing

Limb loading for basic stabilization progression of the lumbar extensors. Begin in the quadruped position and progress the intensity by

  1. Flexing one upper extremity
  2. Extending one lower extremity with a leg slide
  3. Extending one lower extremity by lifting it off the mat
  4. Flexing one upper extremity while extending contralateral lower extremity and then alternate to opposite extremities.

Progress to prone position: 5. Extending one lower extremity 6. Extending both lower extremity

Intervention: Extension Biased External Limb Loading Exercises (Other)

McKenzie Extension with External Limb Loading Protocol

Experimental

Moist Heat Pack for 10 mins

McKenzie Extension Exercise Protocol

Static:

  1. Lying Prone
  2. Lying prone in extension
  3. Sustained extension
  4. Posture correction

Dynamic: 5. Extension in lying 6. Extension in lying with clinician overpressure 7. Extension mobilization 8. Extension in standing

Limb loading for basic stabilization progression of the lumbar extensors. Begin in the quadruped position and progress the intensity by

  1. Flexing one upper extremity
  2. Extending one lower extremity with a leg slide
  3. Extending one lower extremity by lifting it off the mat
  4. Flexing one upper extremity while extending contralateral lower extremity and then alternate to opposite extremities.

Progress to prone position: 5. Extending one lower extremity 6. Extending both lower extremity

Intervention: McKenzie Extension Exercise Protocol (Other)

McKenzie Extension with External Limb Loading Protocol

Experimental

Moist Heat Pack for 10 mins

McKenzie Extension Exercise Protocol

Static:

  1. Lying Prone
  2. Lying prone in extension
  3. Sustained extension
  4. Posture correction

Dynamic: 5. Extension in lying 6. Extension in lying with clinician overpressure 7. Extension mobilization 8. Extension in standing

Limb loading for basic stabilization progression of the lumbar extensors. Begin in the quadruped position and progress the intensity by

  1. Flexing one upper extremity
  2. Extending one lower extremity with a leg slide
  3. Extending one lower extremity by lifting it off the mat
  4. Flexing one upper extremity while extending contralateral lower extremity and then alternate to opposite extremities.

Progress to prone position: 5. Extending one lower extremity 6. Extending both lower extremity

Intervention: Moist Heat (Other)

McKenzie Extension Group

Active Comparator

Moist Heat Pack for 10 mins

McKenzie Extension Protocol Sequence

Static:

  1. Lying Prone
  2. Lying prone in extension
  3. Sustained extension
  4. Posture correction

Dynamic: 5. Extension in lying 6. Extension in lying with clinician overpressure 7. Extension mobilization 8. Extension in standing

Intervention: McKenzie Extension Exercise Protocol (Other)

McKenzie Extension Group

Active Comparator

Moist Heat Pack for 10 mins

McKenzie Extension Protocol Sequence

Static:

  1. Lying Prone
  2. Lying prone in extension
  3. Sustained extension
  4. Posture correction

Dynamic: 5. Extension in lying 6. Extension in lying with clinician overpressure 7. Extension mobilization 8. Extension in standing

Intervention: Moist Heat (Other)

Outcomes

Primary Outcomes

Postural Stability Index PSI will be assessed at the base line and at the end of 2 weeks session.

Time Frame: 2 weeks

Postural stability screening test will be used to determine the postural stability index of the participants.

Clinical Test of Sensory Integration of Balance

Time Frame: 2 weeks

Clinical Test of Sensory Integration of Balance (CTSIB) will be assessed at the base line and at the end of 2 weeks session.

Balance Error Scoring System

Time Frame: 2 weeks

Balance Error Scoring System (BESS) will be assessed at the base line and at the end of 2 weeks session.

Oswestry Disability Index

Time Frame: 2 weeks

Oswestry Disability Index (ODI) assess symptoms and severity of low back pain in terms of disablement and the degree to which back pain impacts functional activities. Questionnaire has been designed to give us information as to how one's back or leg pain is affecting his/her ability to manage in everyday life. It has good person and item reliability with an excellent test retest reliability (ICC= 0.97) and floor effect of 29.9% and ceiling effect of 3.9%. ODI will be assessed at the base line and at the end of 2 weeks session. Lower score shows better outcome.

Fall Risk Test

Time Frame: 2 weeks

Biodex Balance System has a fall risk screening test and conditioning protocol based on well-established science and technology. Screening include analytical balance testing by identifying a potential problem and establishes Z-Score on the basis of mean values. Fall risk will be assessed at the base line and at the end of 2 weeks session. Lower score shows better outcome.

STarT Back Screening Tool

Time Frame: 2 weeks

The Keele STarT Back Screening Tool (SBST) (9-item version) is a brief validated tool, designed to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. STarT will be assessed at the base line and at the end of 2 weeks session.

Range of Motion

Time Frame: 2 weeks

Lumbar ROM including Forward bending, Backward bending, Right side bending and Left side bending will be measured using Inclinometers. ROM will be assessed at the base line and at the end of 2 weeks session. Greater range shows better outcome.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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