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Pilate Mat Exercise Versus Muscle Energy Technique on Chronic Non Specific Low Back Pain (MET-LBP)

Primary Purpose

Chronic Non Specific Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pilate mat exercise will be performed
MET
control group receive standard treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non Specific Low Back Pain focused on measuring LBP, Pilate mat exercise, MET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Seventyeight Subjects will be selected from both genders, with age above 18 years.
  • Normal body mass index (BMI) will be included.
  • Participants diagnosed with chronic nonspecific LBP.

Exclusion Criteria:

  • The participants will be excluded if they had one of the following criteria:
  • Patient with previous back surgery, lumbar disc herniation, spinal deformities.
  • Neuromusculoskeletal problems as hip arthrodesis or arthroplasty and spondylolisthesis.
  • History of Cardiovascular disease, diabetes mellitus and rheumatoid arthritis
  • Pregnant women and Osteoprosis.
  • Leg length discrepancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    pilate group

    MET

    control group

    Arm Description

    will receive pilate exercise(1- bridging 2- shoulder bridge 3- front support 4- spine stretch forward 5- spine twist) and standard treatment (stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions(3 sessions/week) over a period of four weeks.

    will receiveMET treatment for hamstring and erector spinae and standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions (3 sessions/week)over a period of four weeks.

    will receive standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) only for 12 sessions (3 sessions/week) over a period of four weeks.

    Outcomes

    Primary Outcome Measures

    pain intensity
    using visual analogue scale.each patient willbe instructed to rate the current level of pain by placing (X) sign across the horizontal VAS line. The distance in millimeters from the lower limit was measured using a ruler. VAS will be assessed before and after the treatment program.as 1:2 mild , 3:6moderate and 7:10 sever pain.
    functional disability
    using ronald morris questioneer.The RMDQ is scored by adding up the number of items the patient has ticked. Scores can vary between 0-24. Greater levels of disability are reflected by higher scores
    ROM
    using BROMII.Use the two universal inclinometers to make flexion/extension measurements. Measurements with the universal inclinometer need to be with the patient in an upright position. Palpate and mark S1 and T12. Mark on bare skin when possible. This avoids the marks moving with the patient's clothing (Fig.2) Center the two inclinometers over the palpation marks and zero with your finger by spinning the dial (zero would then be at the bottom of the inclinometer). Have the patient flex forward as far as possible (Fig. 3). Note the reading on each inclinometer. The reading on the upper inclinometer is total lumbar flexion. The reading on the lower inclinometer is sacral flexion. The difference between the reading at S1 and T12 is true lumbar flexion. Repeat flexion protocol for extension having the patient extend back for full extension instead of flexing forward
    flexibility
    using V sit and reach test.The test is done twice with a short break in between . Scoring: Zero point is at the level of feet. (We note negative values towards our body and positive values outward from our body.) The best trial is recorded in centimeters by best score

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2022
    Last Updated
    March 21, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05232435
    Brief Title
    Pilate Mat Exercise Versus Muscle Energy Technique on Chronic Non Specific Low Back Pain
    Acronym
    MET-LBP
    Official Title
    Pilate Mat Exercise Versus Muscle Energy Technique on Chronic Non Specific Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 30, 2022 (Anticipated)
    Primary Completion Date
    May 30, 2022 (Anticipated)
    Study Completion Date
    May 30, 2022 (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
    to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:Randomized controlled trial
    Detailed Description
    Low back pain (LBP) affects almost everyone at least once per life. Hence,it has been considered one of the most common musculoskeletal problems.The Pilates Method starts by strengthening the core, which is achieved by coordinating breathing with movement. Muscle energy technique is an associate degree of osteopathic manipulation methodology. The muscles of patients were used, on request, to type a singular controlled position, in a very specific direction, and against a distinctly executed therapist-applied counterforce.pilate mat exercise and muscle energy technique play a major role in treatment of patients with chronic non specific LBP so this trial will be conducted to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Non Specific Low Back Pain
    Keywords
    LBP, Pilate mat exercise, MET

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The trial has 3 groups
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    87 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pilate group
    Arm Type
    Experimental
    Arm Description
    will receive pilate exercise(1- bridging 2- shoulder bridge 3- front support 4- spine stretch forward 5- spine twist) and standard treatment (stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions(3 sessions/week) over a period of four weeks.
    Arm Title
    MET
    Arm Type
    Experimental
    Arm Description
    will receiveMET treatment for hamstring and erector spinae and standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions (3 sessions/week)over a period of four weeks.
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    will receive standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) only for 12 sessions (3 sessions/week) over a period of four weeks.
    Intervention Type
    Other
    Intervention Name(s)
    pilate mat exercise will be performed
    Intervention Description
    pilate group:1- bridging 2- shoulder bridge 3- front support 4- spine stretch forward 5- spine twist plus standard treatment(stretch hamstring -stretch lower back - strength abdominal muscles - electrical heat pad)
    Intervention Type
    Other
    Intervention Name(s)
    MET
    Intervention Description
    Will receive MET for hamstring and erectorspinae plus standard treatment
    Intervention Type
    Other
    Intervention Name(s)
    control group receive standard treatment
    Intervention Description
    electrical heat pad - stretch hamstring - stretch lower back muscles - stregth abdominal muscles
    Primary Outcome Measure Information:
    Title
    pain intensity
    Description
    using visual analogue scale.each patient willbe instructed to rate the current level of pain by placing (X) sign across the horizontal VAS line. The distance in millimeters from the lower limit was measured using a ruler. VAS will be assessed before and after the treatment program.as 1:2 mild , 3:6moderate and 7:10 sever pain.
    Time Frame
    up to 4 weeks for each group
    Title
    functional disability
    Description
    using ronald morris questioneer.The RMDQ is scored by adding up the number of items the patient has ticked. Scores can vary between 0-24. Greater levels of disability are reflected by higher scores
    Time Frame
    up to 4 weeks for each group
    Title
    ROM
    Description
    using BROMII.Use the two universal inclinometers to make flexion/extension measurements. Measurements with the universal inclinometer need to be with the patient in an upright position. Palpate and mark S1 and T12. Mark on bare skin when possible. This avoids the marks moving with the patient's clothing (Fig.2) Center the two inclinometers over the palpation marks and zero with your finger by spinning the dial (zero would then be at the bottom of the inclinometer). Have the patient flex forward as far as possible (Fig. 3). Note the reading on each inclinometer. The reading on the upper inclinometer is total lumbar flexion. The reading on the lower inclinometer is sacral flexion. The difference between the reading at S1 and T12 is true lumbar flexion. Repeat flexion protocol for extension having the patient extend back for full extension instead of flexing forward
    Time Frame
    up to 4 weeks for each group
    Title
    flexibility
    Description
    using V sit and reach test.The test is done twice with a short break in between . Scoring: Zero point is at the level of feet. (We note negative values towards our body and positive values outward from our body.) The best trial is recorded in centimeters by best score
    Time Frame
    upto 4 weeks for each group

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Seventyeight Subjects will be selected from both genders, with age above 18 years. Normal body mass index (BMI) will be included. Participants diagnosed with chronic nonspecific LBP. Exclusion Criteria: The participants will be excluded if they had one of the following criteria: Patient with previous back surgery, lumbar disc herniation, spinal deformities. Neuromusculoskeletal problems as hip arthrodesis or arthroplasty and spondylolisthesis. History of Cardiovascular disease, diabetes mellitus and rheumatoid arthritis Pregnant women and Osteoprosis. Leg length discrepancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    hager na hekal, PHD student
    Phone
    00201016549132
    Email
    hager_in@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    hager hekal, PHD student
    Organizational Affiliation
    faculty of physical therapy
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Pilate Mat Exercise Versus Muscle Energy Technique on Chronic Non Specific Low Back Pain

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