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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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ClinicalTrials.gov Identifier: NCT04155450
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Foundation University Islamabad

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.


Condition or disease Intervention/treatment Phase
Sciatica Low Back Pain Low Back Pain, Mechanical Other: Extension Biased External Limb Loading Exercises Other: McKenzie Extension Exercise Protocol Other: Moist Heat Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participant is unaware of the treatment group he is in.
Primary Purpose: Treatment
Official Title: Effects of Extension Biased External Limb Loading in Addition to McKenzie Extension Protocol in Lumbar Derangement Syndrome
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: McKenzie Extension with External Limb Loading Protocol

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
Other: Extension Biased External Limb Loading Exercises

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
Other Name: Core stability exercises

Other: 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

Other: Moist Heat
Moist Heating for 10 minutes at lumbar spine in prone position using moist heat packs, heated via hydro-collator.

Active Comparator: McKenzie Extension Group

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
Other: 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

Other: Moist Heat
Moist Heating for 10 minutes at lumbar spine in prone position using moist heat packs, heated via hydro-collator.




Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 2 weeks ]

    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.


  2. Fall Risk Test (Overall stability Index) [ 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.


  3. Postural Stability Index (PSI). 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.

  4. Range of Motion (ROM) [ 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.


  5. Clinical Test of Sensory Integration of Balance (CTSIB) [ Time Frame: 2 weeks ]
    CTSIB will be assessed at the base line and at the end of 2 weeks session.

  6. Balance Error Scoring System (BESS) [ Time Frame: 2 weeks ]
    BESS will be assessed at the base line and at the end of 2 weeks session.

  7. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155450


Contacts
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Contact: Shoaib Kayani, DPT, MS-OMPT* 03335585082 shoaibkeyani@gmail.com

Locations
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Pakistan
Foundation University Islamabad Recruiting
Islamabad, Federal, Pakistan, 46000
Contact: Muhammad Osama    03325540436    osamadpt@gmail.com   
Principal Investigator: Shoaib Kayani, DPT, MSOMPT*         
Sponsors and Collaborators
Foundation University Islamabad
Investigators
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Principal Investigator: Shoaib Kayani, DPT, MS-OMPT* Foundation University Islamabad
Study Director: Muhammad Osama, DPT, MSOMPT, CHPE, ACMEd, PhD* Foundation University Islamabad

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Responsible Party: Foundation University Islamabad
ClinicalTrials.gov Identifier: NCT04155450     History of Changes
Other Study ID Numbers: FUI/CTR/2019/2
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Foundation University Islamabad:
exercise
manipulation, spinal
rehabilitation
therapy, manual
manual therapy
Additional relevant MeSH terms:
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Sciatica
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia