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Effect of the Hands- on McKenzie Program on Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
McKenzie group
Control group
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- The patients will be age from 18 to 60 years old, and have LBP with or without leg pain, lasting from seven weeks to 12 weeks or more. Additional criteria include recurrent LBP, demonstrating a DP during the mechanical assessment , The subjects have a BMI of normal (17 to 23.9) or overweight (24 to 28.9). Patient is Eligible.

Exclusion Criteria:

Participants who are underweight (BMI < 18.5) or obese (BMI ≥ 30) will be excluded . Those with contraindications to physical exercise according to the guidelines of the American College of Sports Medicine , such as those with serious spinal pathologies (fractures, tumours, and inflammatory diseases, such as ankylosing spondylitis), nerve root compromise (e.g., cauda equine syndrome), severe cardiopulmonary diseases,SCD, or pregnancy will be excluded.

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    McKenzie group

    Control group

    Arm Description

    This group will receive Hand-on technique on the lumbar spine.

    The Group will not receive Hand-on technique on the lumbar spine.

    Outcomes

    Primary Outcome Measures

    Pain Numerical Rating Scale (PNRS).
    For assessing the pain in the low back.

    Secondary Outcome Measures

    Spine mobility
    In the flexion/extension/rotation and side bending(Right -Left)
    Centralization or non-centralizer (Peripheralization) of patient symptoms.
    Using the body chart.
    Postural alterations.
    It is measure by Postural Analysis Grid (PAG) and software
    Disability associated with LBP
    It is measure by The Oswestry Disability Index (ODI)

    Full Information

    First Posted
    February 23, 2017
    Last Updated
    August 18, 2017
    Sponsor
    Imam Abdulrahman Bin Faisal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03066674
    Brief Title
    Effect of the Hands- on McKenzie Program on Low Back Pain
    Official Title
    Effect of the Hands- on McKenzie Program on Derangement Syndrome in Sub-acute and Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    January 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Imam Abdulrahman Bin Faisal University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Low back pain (LBP) is one of most prevalent types of musculoskeletal pain and is strongly related to disability. The McKenzie method is one of most popular treatment options for LBP. The objectives of this study are to determine the effect of the hands-on McKenzie program on pain, disability, spine mobility, and posture deviations in subjects with derangement low back pain.
    Detailed Description
    Thirty eight patients with sub-acute and chronic LBP will be randomly assigned to the McKenzie group (MG) or the control group (CG). The MG will perform exercises with the hands-on procedure (three sessions per week) for two weeks, while the CG will perform only exercises for two weeks. Both groups will do a home exercise program. The outcome assessments will measure pain by the Pain Numerical Rating Scale (NPRS), the level of disability through the Oswestry Disability Index (ODI), spine mobility by range of motion (ROM) for the lumbar spine, and the centralization of symptoms and the postural alternation by postural analysis grid (PAG). By using SPSS version 20, a paired t-test will be use to study the effect of the McKenzie program before and after treatment. An independent t-test will be used to study the significance between the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    McKenzie group
    Arm Type
    Experimental
    Arm Description
    This group will receive Hand-on technique on the lumbar spine.
    Arm Title
    Control group
    Arm Type
    Experimental
    Arm Description
    The Group will not receive Hand-on technique on the lumbar spine.
    Intervention Type
    Other
    Intervention Name(s)
    McKenzie group
    Intervention Description
    Mobilization for lumbar spine,TENS,Exercises,Postural education ,Home exercises program.
    Intervention Type
    Other
    Intervention Name(s)
    Control group
    Other Intervention Name(s)
    without any Hand -on Technique.
    Intervention Description
    TENS,Exercises,Postural education ,Home exercises program.
    Primary Outcome Measure Information:
    Title
    Pain Numerical Rating Scale (PNRS).
    Description
    For assessing the pain in the low back.
    Time Frame
    Two weeks
    Secondary Outcome Measure Information:
    Title
    Spine mobility
    Description
    In the flexion/extension/rotation and side bending(Right -Left)
    Time Frame
    Two weeks
    Title
    Centralization or non-centralizer (Peripheralization) of patient symptoms.
    Description
    Using the body chart.
    Time Frame
    Two weeks.
    Title
    Postural alterations.
    Description
    It is measure by Postural Analysis Grid (PAG) and software
    Time Frame
    Two weeks
    Title
    Disability associated with LBP
    Description
    It is measure by The Oswestry Disability Index (ODI)
    Time Frame
    Two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - The patients will be age from 18 to 60 years old, and have LBP with or without leg pain, lasting from seven weeks to 12 weeks or more. Additional criteria include recurrent LBP, demonstrating a DP during the mechanical assessment , The subjects have a BMI of normal (17 to 23.9) or overweight (24 to 28.9). Patient is Eligible. Exclusion Criteria: Participants who are underweight (BMI < 18.5) or obese (BMI ≥ 30) will be excluded . Those with contraindications to physical exercise according to the guidelines of the American College of Sports Medicine , such as those with serious spinal pathologies (fractures, tumours, and inflammatory diseases, such as ankylosing spondylitis), nerve root compromise (e.g., cauda equine syndrome), severe cardiopulmonary diseases,SCD, or pregnancy will be excluded. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    LINA A ALBANAWI, MASTER
    Organizational Affiliation
    Imam Abdulrahman Bin Faisal University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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