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Trunk Muscles and Lumbar Intervertebral Disc Degeneration in Combat Sports

Primary Purpose

Other Intervertebral Disc Degeneration, Lumbar Region

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lumbar disc degeneration; LDD
Sponsored by
National Institute of Technology, Hiroshima College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Other Intervertebral Disc Degeneration, Lumbar Region focused on measuring Muscular Atrophy, Asymmetry, Athletes

Eligibility Criteria

19 Years - 23 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • collegiate high-level combat athletes

Exclusion Criteria:

  • previous lumbar surgery and specific low back pain

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lumbar disc degeneration; LDD

    Arm Description

    The LDD group included subjects with at least 1 abnormal disc from L1-2 to L5-S1 of grade III, IV, or V. The non-LDD group included subjects with 5 normal discs of grade I or II. For further assessment, the most damaged disc of the 5 constituted the highest grade of LDD.

    Outcomes

    Primary Outcome Measures

    Cross-sectional area or trunk muscles
    Transverse MR spin-echo T1-weighted images

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2016
    Last Updated
    April 16, 2016
    Sponsor
    National Institute of Technology, Hiroshima College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02744781
    Brief Title
    Trunk Muscles and Lumbar Intervertebral Disc Degeneration in Combat Sports
    Official Title
    Smaller Size and Asymmetry of Trunk Muscles in Combat Sports Athletes With Lumbar Intervertebral Disc Degeneration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2001 (undefined)
    Primary Completion Date
    March 2004 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Institute of Technology, Hiroshima College

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study examined whether there is an association between the presence of lumbar intervertebral disc degeneration (LDD) and the size and symmetry of the cross-sectional areas (CSAs) of the trunk muscles in combat sports athletes. Participants in this study were collegiate combat sports athletes. All intervertebral discs from L1/2 to L5/S1 in all athletes were assessed using MRI and a comprehensive grading system of LDD (grades I-V). All 151 athletes were divided into 2 groups: LDD and non-LDD. CSAs of trunk muscles at the L3/4 disc level were measured on MRI.
    Detailed Description
    The athletes lay on a bed in the MR imaging unit in a comfortable and relaxed supine position. MR imaging was performed with a 0.3-T MR using surface coils with the body coil in the supine position (AIRIS II, Hitachi, Tokyo, Japan). T2-weighted fast spin-echo imaging was used to obtain sagittal images of the lumbar spine and intervertebral discs (repetition time, 3000 ms; echo time, 112 ms; matrix, 256 × 265; field of view, 320 mm; slice thickness, 10 mm). All MR images, taken at 5 lumbar intervertebral disc levels from the first lumbar (L1) vertebra to the first sacral vertebra (S1), were independently evaluated by 2 experienced orthopedic specialists in a random order using a grading system for LDD assessment. Using a comprehensive grading system for LDD, discs were classified into 5 grades, as described by Pfirrman et al. This system uses characteristics of disc structure, distinction between the nucleus and annulus, MRI signal intensity, and intervertebral disc height for grading, and has been accepted as a standardized and reliable evaluation tool for assessment of MRI disc morphology. The assessment was blinded so as not to disclose any knowledge about the athlete's condition, such as the subjective functional disability level of LBP. When the 2 experienced orthopedic specialists had differing opinions on disc grades, the disagreements were debated and resolved with discussion. The 151 participating athletes were divided into 2 groups: LDD and non-LDD. The LDD group included subjects with at least 1 abnormal disc from L1-2 to L5-S1 of grade III, IV, or V. The non-LDD group included subjects with 5 normal discs of grade I or II. For further assessment, the most damaged disc of the 5 constituted the highest grade of LDD. CSAs of trunk muscles Transverse MR spin-echo T1-weighted images were obtained at the L3-4 level parallel to the lumbar disc space (repetition time, 760 ms; echo time, 20 ms; matrix, 256 × 265; field of view, 320 mm; slice thickness, 5.0 mm). The image was traced onto paper and the traced image was then transferred to a computer in order to measure CSAs. CSAs were calculated using image analysis software (Scion Image Beta 4.02, Scion Corp., Frederick, MD, USA), and grouped into 5 large areas because they had poorly defined borders. Each of the 5 areas was represented by the same CSA on the left and right sides of the transverse image (rectus abdominis, obliques, psoas, quadratus lumborum, and lumbar erector spinae plus multifidus). The 5 areas were summed to determine the total area. Three of the CSAs included multiple muscles: obliques, psoas, and lumbar erector spinae). Oblique muscles comprise the internal and external obliques and transversus abdominis. Psoas muscles comprise the psoas major and minor muscles. The lumbar erector spinae includes the iliocostalis, longissimus, and spinalis. All CSAs were normalized by dividing the values by the athlete's body weight. This method was used because most of the combat sports adopt the weight category system, and a previous study reported the correlation between CSAs of the trunk muscles in athletes according to their body mass.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Other Intervertebral Disc Degeneration, Lumbar Region
    Keywords
    Muscular Atrophy, Asymmetry, Athletes

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lumbar disc degeneration; LDD
    Arm Type
    Experimental
    Arm Description
    The LDD group included subjects with at least 1 abnormal disc from L1-2 to L5-S1 of grade III, IV, or V. The non-LDD group included subjects with 5 normal discs of grade I or II. For further assessment, the most damaged disc of the 5 constituted the highest grade of LDD.
    Intervention Type
    Device
    Intervention Name(s)
    Lumbar disc degeneration; LDD
    Intervention Description
    All MR images, taken at 5 lumbar intervertebral disc levels from the first lumbar (L1) vertebra to the first sacral vertebra (S1), were independently evaluated by 2 experienced orthopedic specialists in a random order using a grading system for LDD assessment. Using a comprehensive grading system for LDD, discs were classified into 5 grades, as described by Pfirrman et al. This system uses characteristics of disc structure, distinction between the nucleus and annulus, MRI signal intensity, and intervertebral disc height for grading, and has been accepted as a standardized and reliable evaluation tool for assessment of MRI disc morphology.
    Primary Outcome Measure Information:
    Title
    Cross-sectional area or trunk muscles
    Description
    Transverse MR spin-echo T1-weighted images
    Time Frame
    an average of 1 month

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    23 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: collegiate high-level combat athletes Exclusion Criteria: previous lumbar surgery and specific low back pain

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Trunk Muscles and Lumbar Intervertebral Disc Degeneration in Combat Sports

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