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

Primary Purpose

Sciatica, Low Back Pain, Low Back Pain, Mechanical

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Extension Biased External Limb Loading Exercises
McKenzie Extension Exercise Protocol
Moist Heat
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatica focused on measuring exercise, manipulation, spinal, rehabilitation, therapy, manual, manual therapy

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foundation University Islamabad
  • Shafi International Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

McKenzie Extension with External Limb Loading Protocol

McKenzie Extension Group

Arm Description

Moist Heat Pack for 10 mins McKenzie Extension Exercise Protocol Static: Lying Prone Lying prone in extension Sustained extension Posture correction Dynamic: Extension in lying Extension in lying with clinician overpressure Extension mobilization Extension in standing Limb loading for basic stabilization progression of the lumbar extensors. Begin in the quadruped position and progress the intensity by Flexing one upper extremity Extending one lower extremity with a leg slide Extending one lower extremity by lifting it off the mat Flexing one upper extremity while extending contralateral lower extremity and then alternate to opposite extremities. Progress to prone position: Extending one lower extremity Extending both lower extremity

Moist Heat Pack for 10 mins McKenzie Extension Protocol Sequence Static: Lying Prone Lying prone in extension Sustained extension Posture correction Dynamic: Extension in lying Extension in lying with clinician overpressure Extension mobilization Extension in standing

Outcomes

Primary Outcome Measures

Oswestry Disability Index
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
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.
Postural Stability Index PSI will be assessed at the base line and at the end of 2 weeks session.
Postural stability screening test will be used to determine the postural stability index of the participants.
Range of Motion
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.
Clinical Test of Sensory Integration of Balance
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
Balance Error Scoring System (BESS) will be assessed at the base line and at the end of 2 weeks session.
STarT Back Screening Tool
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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2019
Last Updated
December 3, 2021
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT04155450
Brief Title
Effects of Extension Biased External Limb Loading in Addition to McKenzie Extension Protocol in Lumbar Derangement Syndrome
Official Title
Effects of Extension Biased External Limb Loading in Addition to McKenzie Extension Protocol in Lumbar Derangement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. Progressive limb loading exercises at lumbar region fall under two categories, one group emphasis on abdominal musculature and the second group emphasize on lumbar extensor musculature. Patient begins from quadruped position and progress towards prone position initiating with low intensity training and progressing towards greater intensity along with spinal compression in case of lumbar extensors. Progression towards prone position at the end range of motion requires greater control of neutral spine thus providing excellent stabilization of lumbar extensors. A randomized controlled trial on McKenzie treatment approach in people with chronic low back pain conducted by M.H Halliday et al. provide preliminary evidence that treatment effects of McKenzie Exercises are greater when the core principles are followed with significant reduction in pain and disability of 15.2 [95% CI 7.6 to 22.7] and 11.7 [95% CI 5.4 to18.0]. Srivastav et al. conducted a study at mechanical low back pain with significant improvement having p<0.05 at NPRS & MODI after application of lumbar stabilization exercises along with conventional physical therapy. An international survey conducted in 15 different countries in 2019 regarding McKenzie classification system involving 64.8% lumbar, 29.6% cervical, 5.6% thoracic spine of 750 patients fulfilling MDT criteria revealed 0.1% postural syndrome, 1.7% dysfunction syndrome, 75.4% derangement and 22.8% other. In derangement syndrome 82.5% were extension biased thus Derangement is the most commonly encountered pain syndrome and extension is so far the most common directional preference. With the help of this study the investigators can 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 add to the existing pool of knowledge in the fields of conservative spinal management, physical therapy, orthopedic manual therapy and musculoskeletal medicine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica, Low Back Pain, Low Back Pain, Mechanical
Keywords
exercise, manipulation, spinal, rehabilitation, therapy, manual, manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participant is unaware of the treatment group he is in.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
McKenzie Extension with External Limb Loading Protocol
Arm Type
Experimental
Arm Description
Moist Heat Pack for 10 mins McKenzie Extension Exercise Protocol Static: Lying Prone Lying prone in extension Sustained extension Posture correction Dynamic: Extension in lying Extension in lying with clinician overpressure Extension mobilization Extension in standing Limb loading for basic stabilization progression of the lumbar extensors. Begin in the quadruped position and progress the intensity by Flexing one upper extremity Extending one lower extremity with a leg slide Extending one lower extremity by lifting it off the mat Flexing one upper extremity while extending contralateral lower extremity and then alternate to opposite extremities. Progress to prone position: Extending one lower extremity Extending both lower extremity
Arm Title
McKenzie Extension Group
Arm Type
Active Comparator
Arm Description
Moist Heat Pack for 10 mins McKenzie Extension Protocol Sequence Static: Lying Prone Lying prone in extension Sustained extension Posture correction Dynamic: Extension in lying Extension in lying with clinician overpressure Extension mobilization Extension in standing
Intervention Type
Other
Intervention Name(s)
Extension Biased External Limb Loading Exercises
Other Intervention Name(s)
Core stability exercises
Intervention Description
Begin in the quadruped position and progress the intensity by Flexing one upper extremity Extending one lower extremity with a leg slide Extending one lower extremity by lifting it off the mat Flexing one upper extremity while extending contralateral lower extremity and then alternate to opposite extremities. Progress to prone position: Extending one lower extremity Extending both lower extremity
Intervention Type
Other
Intervention Name(s)
McKenzie Extension Exercise Protocol
Intervention Description
Static: Lying Prone Lying prone in extension Sustained extension Posture correction Dynamic: Extension in lying Extension in lying with clinician overpressure Extension mobilization Extension in standing
Intervention Type
Other
Intervention Name(s)
Moist Heat
Intervention Description
Moist Heating for 10 minutes at lumbar spine in prone position using moist heat packs, heated via hydro-collator.
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Description
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.
Time Frame
2 weeks
Title
Fall Risk Test
Description
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.
Time Frame
2 weeks
Title
Postural Stability Index PSI will be assessed at the base line and at the end of 2 weeks session.
Description
Postural stability screening test will be used to determine the postural stability index of the participants.
Time Frame
2 weeks
Title
Range of Motion
Description
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.
Time Frame
2 weeks
Title
Clinical Test of Sensory Integration of Balance
Description
Clinical Test of Sensory Integration of Balance (CTSIB) will be assessed at the base line and at the end of 2 weeks session.
Time Frame
2 weeks
Title
Balance Error Scoring System
Description
Balance Error Scoring System (BESS) will be assessed at the base line and at the end of 2 weeks session.
Time Frame
2 weeks
Title
STarT Back Screening Tool
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shoaib Kayani, DPT, MS-OMPT*
Organizational Affiliation
Foundation University Islamabad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammad Osama, DPT, MSOMPT, CHPE, ACMEd, PhD*
Organizational Affiliation
Foundation University Islamabad
Official's Role
Study Director
Facility Information:
Facility Name
Foundation University Islamabad
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Shafi International Hospital
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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