UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061577 |
|---|---|
| Receipt number | R000070368 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/05/14 |
| Last modified on | 2026/05/14 18:59:58 |
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Basic information
Public title
A prospective randomized trial comparing lumbar corset use versus no corset after full-endoscopic spine surgery for lumbar spinal stenosis
Acronym
FESS-Corset Trial
Scientific Title
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
Scientific Title:Acronym
FESS-Corset Trial
Region
| Japan |
Condition
Condition
Lumbar spinal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether postoperative management without a lumbar corset is non-inferior to management with a lumbar corset after FESS decompression for lumbar spinal stenosis, with respect to the Oswestry Disability Index (ODI) at 6 weeks postoperatively. The primary endpoint is the ODI at 6 weeks postoperatively (0-100 points).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Oswestry Disability Index (ODI, 0-100 points) at 6 weeks postoperatively. Higher scores indicate greater low back-related disability.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
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 clinical practice at the institution. Surgical procedures, analgesia, mobilization, rehabilitation, and other perioperative management will be standardized between groups. No additional examinations will be performed solely for research purposes.
Interventions/Control_2
Group B (no corset group): After FESS decompression for lumbar spinal stenosis, patients will not wear a lumbar corset. Surgical procedures, analgesia, mobilization, rehabilitation, and other perioperative management will be standardized between groups. No additional examinations will be performed solely for research purposes.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
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 apparent instability, degenerative spondylolisthesis, or other conditions requiring concomitant fusion surgery.
4. Patients deemed inappropriate for inclusion by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Takenaka |
Organization
Japan Community Healthcare Organization Osaka Hospital
Division name
Department of Orthopaedic Surgery
Zip code
553-0003
Address
4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan
TEL
0664415451
show@yb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Takenaka |
Organization
Japan Community Healthcare Organization Osaka Hospital
Division name
Department of Orthopaedic Surgery
Zip code
553-0003
Address
4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan
TEL
0664415451
Homepage URL
show@yb3.so-net.ne.jp
Sponsor or person
Institute
Japan Community Healthcare Organization Osaka Hospital
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
Japan Community Healthcare Organization Osaka Hospital review board
Address
4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan
Tel
06-6441-5451
horimoto-takiko@osaka.jcho.go.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 | 05 | Month | 14 | 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
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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 29 | 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 | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070368
