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Effects of Sustained Natural Apophyseal Glides in Combination With McKenzie Extension Protocol in the Management of Discogenic Low Back Pain

Primary Purpose

Low Back Pain, Disk Prolapse, Disk Herniated Lumbar

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mckenzie Extension Protocol
Lumbar SNAGs
inferential therapy
Heat Therapy
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Both male and female participants
  • aged 18-50 years old
  • low back pain intensity less than 80/100mm on visual analogue scale
  • positive centralization phenomenon
  • low signal intensity of IV disc on T2 - weighted MRI
  • high intensity zone towards the posterior aspect of the disc on MRI

Exclusion Criteria:

Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.

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Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental Group

    Active Comparator Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Back Pain
    Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.
    Lumbar Range of Motion
    Disability will be measured via inclinometer. A higher score signifies good outcome.
    Postural Stability
    Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.
    Lumbar Disability
    Disability will be measured via Oswestry Disability Index.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 29, 2022
    Last Updated
    March 29, 2022
    Sponsor
    Foundation University Islamabad
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05314049
    Brief Title
    Effects of Sustained Natural Apophyseal Glides in Combination With McKenzie Extension Protocol in the Management of Discogenic Low Back Pain
    Official Title
    Effects of Sustained Natural Apophyseal Glides (SNAGs) in Combination With McKenzie Extension Protocol (Mechanical Diagnostic Therapy) in the Management of Discogenic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    October 30, 2022 (Anticipated)
    Study Completion Date
    October 30, 2022 (Anticipated)

    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
    Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition. McKenzie's extension protocol is considered to be the gold standard physical therapy treatment for persons with acute discogenic low back pain, however the evidence is deficient in terms of additive benefits of sustained natural apophyseal glides in the management of discogenic low back pain. Thus, the current study will not only look into the positive effects of McKenzie's extension protocol in the management discogenic low back pain, but will also look into the additive benefits of sustained natural apophyseal glides in combination with McKenzie's extension protocol in the management of discogenic low back pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Disk Prolapse, Disk Herniated Lumbar, Sciatic Radiculopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Title
    Active Comparator Group
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Mckenzie Extension Protocol
    Intervention Description
    Mckenzie Extension Exercise Protocol will be performed by participants in prone position
    Intervention Type
    Procedure
    Intervention Name(s)
    Lumbar SNAGs
    Intervention Description
    Lumbar SNAGs will be performed in lumbar flexion and extension in standing Position
    Intervention Type
    Device
    Intervention Name(s)
    inferential therapy
    Intervention Description
    4 pole inferential therapy in combination with superficial heating for 20 minutes
    Intervention Type
    Device
    Intervention Name(s)
    Heat Therapy
    Intervention Description
    superficial heating for 20 minutes
    Primary Outcome Measure Information:
    Title
    Back Pain
    Description
    Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.
    Time Frame
    2 weeks
    Title
    Lumbar Range of Motion
    Description
    Disability will be measured via inclinometer. A higher score signifies good outcome.
    Time Frame
    2 weeks
    Title
    Postural Stability
    Description
    Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.
    Time Frame
    2 weeks
    Title
    Lumbar Disability
    Description
    Disability will be measured via Oswestry Disability Index.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Both male and female participants aged 18-50 years old low back pain intensity less than 80/100mm on visual analogue scale positive centralization phenomenon low signal intensity of IV disc on T2 - weighted MRI high intensity zone towards the posterior aspect of the disc on MRI Exclusion Criteria: Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muhammad Osama, PhD*
    Phone
    +923325540436
    Email
    osama@fui.edu.pk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muhammad Osama, PhD*
    Email
    osama@fui.edu.pk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Sustained Natural Apophyseal Glides in Combination With McKenzie Extension Protocol in the Management of Discogenic Low Back Pain

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