Clinical Trial: A prospective randomized controlled non-inferiority trial evaluating the necessity of lumbar corset use after full-endoscopic discectomy for lumbar disc herniation, with early postoperative Oswestry Disability Index as the primary endpoint (Japan)

Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061576) titled 'A prospective randomized trial evaluating the necessity of lumbar corset use after full-endoscopic discectomy for lumbar disc herniation' on May 14.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Japan Community Healthcare Organization Osaka Hospital

Condition: Condition - Lumbar disc herniation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the Oswestry Disability Index (ODI) at 6 weeks postoperatively between patients treated with and without lumbar corset use after full-endoscopic discectomy (FED) for lumbar disc herniation, and to test the non-inferiority of the no-corset group. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Group A (lumbar corset group): After full-endoscopic discectomy (FED) for lumbar disc herniation, patients will wear a lumbar corset (Lumbamed) for 6 weeks postoperatively. Surgery, analgesics, mobilization, rehabilitation, and other perioperative management will follow standard clinical practice at our institution and will be unified between groups as much as possible. No additional examinations or imaging will be performed solely for research purposes. Interventions/Control_2 - Group B (no-corset group): After FED for lumbar disc herniation, patients will not wear a lumbar corset during the first 6 weeks postoperatively in principle. Surgery, analgesics, mobilization, rehabilitation, and other perioperative management will follow standard clinical practice at our institution and will be unified between groups as much as possible. No additional examinations or imaging will be performed solely for research purposes. If the attending physician judges that corset use is necessary for safety, clinical care will take priority and the details will be recorded.

Eligibility: Age-lower limit - 20 years-old =20 years 3. Patients with single-level lumbar disc herniation who are deemed suitable for FED 4. Patients who have provided written informed consent Key exclusion criteria - 1. Patients undergoing revision surgery 2. Patients in whom non-degenerative conditions, such as infection, tumor, trauma, or deformity, are the primary pathology 3. Patients with obvious instability, severe bony stenosis, or a condition judged to require concomitant fusion surgery 4. Patients deemed inappropriate for inclusion by the principal investigator Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 04 Month 27 Day Date of IRB - 2026 Year 05 Month 14 Day Anticipated trial start date - 2026 Year 05 Month 14 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070367

Disclaimer: Curated by HT Syndication.