UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061576 |
|---|---|
| Receipt number | R000070367 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/05/14 |
| Last modified on | 2026/05/14 18:56:55 |
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Basic information
Public title
A prospective randomized trial evaluating the necessity of lumbar corset use after full-endoscopic discectomy for lumbar disc herniation
Acronym
FED-CORSET Trial
Scientific Title
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
Scientific Title:Acronym
FED-CORSET Trial
Region
| Japan |
Condition
Condition
Lumbar disc herniation
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Oswestry Disability Index (ODI) score at 6 weeks postoperatively. ODI is assessed on a 0-100 scale, with higher scores indicating greater disability.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
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 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.
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 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
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 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
06-6441-5451
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
Shota Takenaka
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 Health Care Organization Osaka Hospital
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 | 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 |
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=R000070367
