Other Intervertebral Disc Degeneration, Lumbar RegionNCT02744781
Trunk Muscles and Lumbar Intervertebral Disc Degeneration in Combat Sports
A study testing Lumbar disc degeneration; LDD in people with Other Intervertebral Disc Degeneration, Lumbar Region, run by National Institute of Technology, Hiroshima College.
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. Read more about this study
- Who is it for?
- Ages 19 to 23 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Other Intervertebral Disc Degeneration, Lumbar Region
- What is being tested?
- Lumbar disc degeneration; LDD
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 23 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- collegiate high-level combat athletes
Who cannot join
- previous lumbar surgery and specific low back pain
About this study
Official title: Smaller Size and Asymmetry of Trunk Muscles in Combat Sports Athletes With Lumbar Intervertebral Disc Degeneration
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.
Read the 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.
- Being tested
- Lumbar disc degeneration; LDD
- Keywords
- Muscular Atrophy, Asymmetry, Athletes
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar disc degeneration; LDDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar disc degeneration; LDD | Experimental | 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. Receives: Device: Lumbar disc degeneration; LDD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area or trunk muscles
Transverse MR spin-echo T1-weighted images
Measured: an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2001
- Primary completionMar 2004
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Intervertebral Disc Degeneration, Lumbar RegionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Technology, Hiroshima College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IWAI Kazunori, National Institute of Technology, Hiroshima College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744781
- Sponsor's protocol ID
- NITHiroshimaC
- Status last verified
- Apr 2016
- First submitted
- 28 Mar 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smaller Size and Asymmetry of Trunk Muscles in Combat Sports Athletes With Lumbar Intervertebral Disc Degeneration
- ClinicalTrials.gov ID
- NCT02744781
- Acronym / sponsor ID
- NITHiroshimaC
- Keywords
- Muscular Atrophy, Asymmetry, Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National Institute of Technology, Hiroshima CollegeUniversity, hospital or other
- Study start
- Apr 2001
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar disc degeneration; LDD | Experimental | Device: Lumbar disc degeneration; LDDThe 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. |
Who may qualify
- Ages
- 19 to 23 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- collegiate high-level combat athletes
Key exclusion criteria (1 listed)
- previous lumbar surgery and specific low back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar disc degeneration; LDDAll 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. | Device | Lumbar disc degeneration; LDD |
Primary outcome
Cross-sectional area or trunk muscles
Time frame: an average of 1 month
Transverse MR spin-echo T1-weighted images
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar disc degeneration; LDD in people with Other Intervertebral Disc Degeneration, Lumbar Region, run by National Institute of Technology, Hiroshima College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional area or trunk muscles (time frame: an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.