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
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
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
NCT ID
NCT02744781
First Posted
March 28, 2016
Last Updated
April 16, 2016
Sponsor
National Institute of Technology, Hiroshima College
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
We'll reach out to this number within 24 hrs