Tokyo, July 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062127) titled 'Effect of lumbar discography and related factors on long-term progression of disc degeneration' on July 10.
Study Type:
Observational
Primary Sponsor:
Institute - Sendai Pain Center
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 malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 120
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071089
Disclaimer: Curated by HT Syndication.
