A prospective randomized trial evaluating the necessity of lumbar corset use after full-endoscopic discectomy for lumbar disc herniation

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 - FED-CORSET Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061576

Enrollment

100

Registered

2026-05-14

Start date

2026-05-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar disc herniation

Interventions

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, mobili

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients scheduled to undergo elective full-endoscopic discectomy for lumbar disc herniation at our institution 2. Age >=20 years 3. Patients with single-level lumbar disc herniation who are deemed suitable for FED 4. Patients who have provided written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Oswestry Disability Index (ODI) score at 6 weeks postoperatively. ODI is assessed on a 0-100 scale, with higher scores indicating greater disability.	—

Secondary

Measure	Time frame
1. Longitudinal changes in ODI preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively 2. Low back pain and leg pain assessed using the 0-100 mm Visual Analog Scale (VAS; average over the preceding 7 days) preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively 3. JOABPEQ, EQ-5D, SF-8, and patient satisfaction with surgery assessed preoperatively and at 3, 6, and 12 months postoperatively, as applicable 4. Radiographic parameters on plain radiographs preoperatively and at 3, 6, and 12 months postoperatively: lumbar lordosis, segmental lordosis, vertebral slip, and dynamic instability if flexion-extension radiographs are obtained 5. Walking ability, analgesic use, and length of hospital stay 6. Wound findings and adverse events up to 12 months postoperatively, including surgical site infection, hematoma, dural tear, neurological worsening, corset-related skin problems, and reoperation 7. Presence or absence of recurrent disc herniation at 12 months postoperatively if imaging is performed in routine clinical practice	—

Measure

Time frame

1. Longitudinal changes in ODI preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively 2. Low back pain and leg pain assessed using the 0-100 mm Visual Analog Scale (VAS; average over the preceding 7 days) preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively 3. JOABPEQ, EQ-5D, SF-8, and patient satisfaction with surgery assessed preoperatively and at 3, 6, and 12 months postoperatively, as applicable 4. Radiographic parameters on plain radiographs preoperatively and at 3, 6, and 12 months postoperatively: lumbar lordosis, segmental lordosis, vertebral slip, and dynamic instability if flexion-extension radiographs are obtained 5. Walking ability, analgesic use, and length of hospital stay 6. Wound findings and adverse events up to 12 months postoperatively, including surgical site infection, hematoma, dural tear, neurological worsening, corset-related skin problems, and reoperation 7. Presence or absence of recurrent disc herniation at 12 months postoperatively if imaging is performed in routine clinical practice

—

Countries

Japan

Contacts

Public ContactShota Takenaka

Japan Community Healthcare Organization Osaka Hospital Department of Orthopaedic Surgery

show@yb3.so-net.ne.jp0664415451

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026