A prospective randomized trial comparing lumbar corset use versus no corset after full-endoscopic spine surgery for lumbar spinal stenosis

Necessity of lumbar corset use after full-endoscopic spine surgery for lumbar spinal stenosis: a prospective randomized non-inferiority trial using early postoperative Oswestry Disability Index as the primary endpoint - FESS-Corset Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061577

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 spinal stenosis

Interventions

Group A (lumbar corset group): After FESS decompression for lumbar spinal stenosis, patients will wear a lumbar corset for 6 weeks postoperatively. The method of corset use will follow routine clinica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients scheduled to undergo elective FESS decompression for lumbar spinal stenosis at our institution. 2. Age >=20 years. 3. Patients with degenerative lumbar spinal stenosis involving one or two levels, without apparent instability, and deemed suitable for decompression alone. 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 apparent instability, degenerative spondylolisthesis, or other conditions requiring concomitant fusion surgery. 4. Patients deemed inappropriate for inclusion by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Oswestry Disability Index (ODI, 0-100 points) at 6 weeks postoperatively. Higher scores indicate greater low back-related disability.	—

Secondary

Measure	Time frame
1. Changes in ODI preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively 2. Low back pain VAS and leg pain VAS preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively (mean pain during the preceding 7 days, 0-100 mm) 3. JOABPEQ, EQ-5D, SF-8, and patient satisfaction with surgery preoperatively and at 3, 6, and 12 months postoperatively 4. Radiographic parameters assessed on plain radiographs preoperatively and at 3, 6, and 12 months postoperatively: lumbar lordosis, segmental lordosis, slip distance, and dynamic instability when flexion-extension radiographs are obtained 5. Walking ability, analgesic use, and length of hospital stay 6. Wound findings and adverse events, including surgical site infection, hematoma, dural injury, worsening neurological symptoms, corset-related skin problems, and reoperation 7. Presence or absence of restenosis at 12 months postoperatively when imaging evaluation is performed as part of routine care	—

Measure

Time frame

1. Changes in ODI preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively 2. Low back pain VAS and leg pain VAS preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively (mean pain during the preceding 7 days, 0-100 mm) 3. JOABPEQ, EQ-5D, SF-8, and patient satisfaction with surgery preoperatively and at 3, 6, and 12 months postoperatively 4. Radiographic parameters assessed on plain radiographs preoperatively and at 3, 6, and 12 months postoperatively: lumbar lordosis, segmental lordosis, slip distance, and dynamic instability when flexion-extension radiographs are obtained 5. Walking ability, analgesic use, and length of hospital stay 6. Wound findings and adverse events, including surgical site infection, hematoma, dural injury, worsening neurological symptoms, corset-related skin problems, and reoperation 7. Presence or absence of restenosis at 12 months postoperatively when imaging evaluation is performed as part of routine care

—

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