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Lumbopelvic Stabilization Versus Pilates Exercises On Gait Phases And Peak Pressure On Foot In Low Back Pain (LBP)

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lumbopelvic stabilization exercises
pilates exercise
conventional therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring lumbopelvaic stabilization exercise, pilates exercise, gait cycle phases, peak pressure

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Their age between 20 and 40 years
  2. patients is required to have chronic nonspecific LBP (more than12 weeks), defined as Pain in the lumbar and/or buttock region (defined as pain reported below the level of T12 and no lower than the buttock line).
  3. Patients will be excluded if they have signs of serious spinal pathology (red flags) including significant trauma, unexplained weight loss, and widespread neurologic changes

Exclusion Criteria:

  1. subjects with specific back pain (fracture, osteoporosis or degenerative changes, prolapse intervertebral disc, bone disorders, arthritis, tumour),
  2. subjects with neurological involvement (radiculopathy, myelopathy),
  3. subjects with previous spinal surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    lumbopelvic stabilization exercises

    Pilates exercises

    conventional therapy

    Arm Description

    the patients will receive trunk stabilization exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months

    the patients will receive trunk pilates exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months

    the patients will receive trunk stabilization exercise three times/ week for three months

    Outcomes

    Primary Outcome Measures

    gait cycle phases and maximum peak pressure on foot
    gait cycle phases and peak pressure will be measure by Tekscan walkway

    Secondary Outcome Measures

    pain intensity
    visual analogue scale will be used for measuring pain level
    disability
    Functional disability of each patient was assessed by Modified Oswestry Disability Questionnaire
    muscle endurance
    Sorensen test (low back fatigue test) and Trunk flexion endurance test will be used for measuring the level of endurance

    Full Information

    First Posted
    June 24, 2021
    Last Updated
    June 24, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04942782
    Brief Title
    Lumbopelvic Stabilization Versus Pilates Exercises On Gait Phases And Peak Pressure On Foot In Low Back Pain
    Acronym
    LBP
    Official Title
    Lumbopelvic Stabilization Versus Pilates Exercises On Gait Cycle Phases And Maximum Peak Pressure On Foot In Chronic Nonspecific Low Back Pain: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2021 (Anticipated)
    Primary Completion Date
    August 1, 2021 (Anticipated)
    Study Completion Date
    August 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

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

    5. Study Description

    Brief Summary
    the purpose of this trial is to investigate and compare between lumbopelvic stabilization and pilates exercises on gait cycle phases and maximum peak pressure on the foot in chronic nonspecific low back pain?
    Detailed Description
    LBP is the leading cause of activity limitation, results in significant losses in productivity at work, and incurs billions of dollars in medical expenditure annually So, the aim of physical therapy treatment in the patient with chronic nonspecific low back pain is more effective in improving gait cycle phases and maximum peak pressure on the foot and help LBP patients to walk normally as much as possible, also this will improve our body of knowledge about the best modalities for treating LBP. The finding of this study may help LBP patients avoid exposure to complications due to altered gait cycle phases and maximum peak pressure on the foot. Also, it will help physiotherapists to know which treatment will be effective in improving gait cycle phases and maximum peak pressure on the foot. one hundred patients with mechanical low back pain will be allocated randomly to three groups; group A will receive pilates, group B will receive lumbopelvic stabilization exercise and group C will receive strengthening exercises for the abdominals, back, and hip muscles

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    lumbopelvaic stabilization exercise, pilates exercise, gait cycle phases, peak pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    lumbopelvic stabilization and Pilates
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    random generator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    lumbopelvic stabilization exercises
    Arm Type
    Experimental
    Arm Description
    the patients will receive trunk stabilization exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months
    Arm Title
    Pilates exercises
    Arm Type
    Experimental
    Arm Description
    the patients will receive trunk pilates exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months
    Arm Title
    conventional therapy
    Arm Type
    Active Comparator
    Arm Description
    the patients will receive trunk stabilization exercise three times/ week for three months
    Intervention Type
    Other
    Intervention Name(s)
    lumbopelvic stabilization exercises
    Intervention Description
    the patients will receive lumbopelvic stabilization in the form of three parts: 1 Segmental control over primary stabilizers (mainly TrA, deep multifidus, pelvic floor and diaphragm) 2-Exercises in closed chain, with low velocity and low load 3-Exercises in open chain, with high velocity and load
    Intervention Type
    Other
    Intervention Name(s)
    pilates exercise
    Intervention Description
    the patient will receive pilates exercise in the form of Breast stroke prep, Side leg lift series, One leg circle, Hundreds, Shoulder bridge, and Spine stretch forward
    Intervention Type
    Other
    Intervention Name(s)
    conventional therapy
    Intervention Description
    Patients will received strengthening exercises for the abdominal, back, and hip muscles. The patients performed an average of three series of ten repetitions of each exercise. Increases in the number of exercises performed in each session (or load progression) occurred according to individual tolerance
    Primary Outcome Measure Information:
    Title
    gait cycle phases and maximum peak pressure on foot
    Description
    gait cycle phases and peak pressure will be measure by Tekscan walkway
    Time Frame
    up to twelve weeks
    Secondary Outcome Measure Information:
    Title
    pain intensity
    Description
    visual analogue scale will be used for measuring pain level
    Time Frame
    up to twelve weeks
    Title
    disability
    Description
    Functional disability of each patient was assessed by Modified Oswestry Disability Questionnaire
    Time Frame
    up to twelve weeks
    Title
    muscle endurance
    Description
    Sorensen test (low back fatigue test) and Trunk flexion endurance test will be used for measuring the level of endurance
    Time Frame
    up to twelve weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Their age between 20 and 40 years patients is required to have chronic nonspecific LBP (more than12 weeks), defined as Pain in the lumbar and/or buttock region (defined as pain reported below the level of T12 and no lower than the buttock line). Patients will be excluded if they have signs of serious spinal pathology (red flags) including significant trauma, unexplained weight loss, and widespread neurologic changes Exclusion Criteria: subjects with specific back pain (fracture, osteoporosis or degenerative changes, prolapse intervertebral disc, bone disorders, arthritis, tumour), subjects with neurological involvement (radiculopathy, myelopathy), subjects with previous spinal surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    al shaymaa sh abd el azeim, lecturer
    Phone
    01033771553
    Email
    alshaymaa.shaaban@pt.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    al shaymaa sh abd el azeim, lecturer
    Phone
    01033771553
    Email
    alshaymaa.ahaaban@pt.cu.edu.eg

    12. IPD Sharing Statement

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