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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02744781
Other study ID # NITHiroshimaC
Secondary ID
Status Completed
Phase N/A
First received March 28, 2016
Last updated April 16, 2016
Start date April 2001
Est. completion date March 2008

Study information

Verified date April 2016
Source National Institute of Technology, Hiroshima College
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Education, Culture, Sports, Science and Technology
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date March 2008
Est. primary completion date March 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 23 Years
Eligibility Inclusion Criteria:

- collegiate high-level combat athletes

Exclusion Criteria:

- previous lumbar surgery and specific low back pain

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
Lumbar disc degeneration; LDD
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Technology, Hiroshima College

Outcome

Type Measure Description Time frame Safety issue
Primary Cross-sectional area or trunk muscles Transverse MR spin-echo T1-weighted images an average of 1 month Yes