UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062127 |
|---|---|
| Receipt number | R000071089 |
| Scientific Title | Long-Term Longitudinal MRI Analysis of Discography-Related Factors, Multifidus Fat Infiltration, and Lumbar Disc Degeneration |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/07/02 21:48:22 |
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Basic information
Public title
Effect of lumbar discography and related factors on long-term progression of disc degeneration
Acronym
Discography and Long-term Disc Degeneration Study
Scientific Title
Long-Term Longitudinal MRI Analysis of Discography-Related Factors, Multifidus Fat Infiltration, and Lumbar Disc Degeneration
Scientific Title:Acronym
Longitudinal Observation of Disc Degeneration by MRI
Region
| Japan |
Condition
Condition
Chronic low back and leg pain due to degenerative lumbar disease (including lumbar disc degeneration, lumbar disc herniation, and lumbar spinal stenosis)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the number of discography procedures and baseline multifidus fat infiltration are associated with long-term progression of lumbar disc degeneration (disc height and Pfirrmann grade) over approximately 10 years, using long-term longitudinal MRI.
Basic objectives2
Others
Basic objectives -Others
Effect of repeated diagnostic procedures and imaging findings on long-term disc degeneration
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in Disc Height Index (DHI change, in percentage points) between baseline MRI and a follow-up MRI performed at least 8 years later.
Progression of Pfirrmann grade (follow-up grade > baseline grade defined as progression).
Key secondary outcomes
Association between discographic finding category and degeneration progression
Association between injection pressure (low/moderate/high) and saline pressurization and degeneration progression
Association between baseline multifidus fat infiltration (Goutallier grade) and degeneration progression
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with low back and/or leg pain who have both a baseline lumbar MRI and a follow-up MRI obtained 8 or more years later, with the L3/4, L4/5, and L5/S1 levels evaluable.
Key exclusion criteria
Prior discography before the baseline MRI; vertebral fracture or spinal surgery (fusion, open discectomy, etc.) during follow-up; severe scoliosis or spondylolisthesis precluding measurement.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | yoshiki |
| Middle name | |
| Last name | kohashi |
Organization
Sendai Pain center
Division name
Department of Anesthesiology
Zip code
983-0036
Address
3-14-1 Shindenhigashi, Miyagino-ku, Sendai, Miyagi 983-0036, Japan
TEL
022-236-1310
y.kohashi@aozora-orthp.com
Public contact
Name of contact person
| 1st name | yoshiki |
| Middle name | |
| Last name | kohashi |
Organization
Sendai Pain center
Division name
Department of Anesthesiology
Zip code
983-0036
Address
3-14-1 Shindenhigashi, Miyagino-ku, Sendai, Miyagi 983-0036, Japan
TEL
022-236-1310
Homepage URL
kohashi@itamitoru.jp
Sponsor or person
Institute
Sendai Pain Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sendai Pain Center
Address
3-14-1 Shindenhigashi, Miyagino-ku, Sendai, Miyagi 983-0036, Japan
Tel
022-236-1310
date@itamitoru.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
120
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2026 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, retrospective, longitudinal (cohort) observational study based on a retrospective review of medical records and MRI. The factors examined for association are the number of discography sessions (none/1/2 or more), percutaneous nucleotomy, injection pressure at discography (low/moderate/high), saline pressurization, discographic findings, and baseline multifidus fat infiltration (Goutallier grade). The outcomes are the change in Disc Height Index (DHI change) and progression of Pfirrmann grade. Sampling was consecutive (total) sampling of all eligible patients, not case-control sampling; no prospective sample-size calculation was performed. Outcome (MRI) assessment was performed blinded to exposure history. Generalized estimating equations (GEE) accounted for within-patient clustering of multiple disc levels, using a Gaussian/identity link for DHI change and a binomial/logit link for Pfirrmann progression, adjusting for age, sex, BMI, follow-up years, disc level, baseline DHI, baseline Pfirrmann grade, and multifidus fat infiltration, with the no-discography group as reference. This is a retrospective observational study.
Management information
Registered date
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071089
