Lumbar Spinal StenosisNCT04876612
Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection
A study testing Transforaminal epidural steroid injection (TFESI) in people with Lumbar Spinal Stenosis, run by Seoul National University at 1 site in South Korea.
Trial summary
The purpose of this study was to compare the effects of limaprost(Opalmon® ) on walking ability, low back pain and leg pain after transforaminal epidural steroid injection (TFESI) was administered compared to the placebo group. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Transforaminal epidural steroid injection (TFESI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Nov 2021to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 85 years
- Patients with a new or known diagnosis of lumbar spinal stenosis on Magnetic Resonance Imaging (MRI)
- Patients scheduled to undergo TFESI due to low back pain or leg pain
Who cannot join
- Refusal of a patient
- Coagulopathy
- Systemic infection or local infection at the needle injection site
- Patients with lumbar instability
- Neoplasms in the needle path
- Allergy to amide-type local anesthetics
Show all 15Show fewer
- Decreased cognition to the extent that NRS is incomprehensible
- Patients with peripheral vascular disease (including peripheral arterial disease)
- Patients taking anticoagulant or antiplatelet drugs
- Patients with severe cardiovascular disease or liver or kidney disease
- Patinets with cerebral infarction
- Patinets with a history of gastrointestinal bleeding
- Patinets who have had lumbar spine surgery or are expected to receive it within 12 months
- Patients who show positive in the straight leg elevation test
- Patients who are allergic or sensitive to limaprost (Opalmon®) and placebo or their ingredients
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Youn Moon Jee, MD, PhD, 82-10-5299-2036, jymoon0901@gmail.com
About this study
Official title: Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection for the Treatment of Lumbar Spinal Stenosis: a Prospective, Double-blind, Randomized Controlled Trial
The purpose of this study was to compare the effects of limaprost(Opalmon® ) on walking ability, low back pain and leg pain after transforaminal epidural steroid injection (TFESI) was administered compared to the placebo group.
Read the detailed description
This study is a prospective, randomized, comparative clinical study that is assigned to a placebo group or a trial group before transforaminal epidural steroid injection (TFESI) is performed.
The subjects of the study will receive an explanation of the study and decide to participate voluntarily in patients who have decided to undergo TFESI for neurogenic claudication and low back pain or leg pain due to lumbar spinal canal stenosis (LSS).
All study subjects are presented with TFESI at the level appropriate for their symptoms in the operating room and then returned to the recovery room. All participants will be monitored for non-invasive blood pressure, electrocardiography, heart rate, and peripheral oxyven saturation during and after the procedure.
Patients assigned to the placebo group will take placebo three times a day and one tablet once from the first day after receiving TFESI. Patients assigned to the trial group will take limaprost (Opalmon®) three times a day, one tablet once from the first day after receiving TFESI. In both groups, the drug was administered for 12 weeks.
In both groups, during the first 4 weeks, no drug changes or additional procedures were observed, and only Acetaminophen was allowed as a rescue drug.
After TFESI, visits at 4 weeks, 8 weeks and 12 weeks to collect each measurement variable.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Transforaminal epidural steroid injection (TFESI)
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal epidural steroid injection (TFESI)Procedure or surgery
Well trained pain physician performs all the fluoroscopy-guided transforaminal epidural steroid injection (TFESI), who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For TFESI, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under fluoroscopy guidance at the patient's symptom complaining level. After confirming with a contrast medium, 3 ml of 0.1875% ropivacaine and 5 mg of dexamethasone are administered.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received placebo after transforminal epidural steroid injection | Placebo comparator | Patients who took placebo for 12 weeks after TFESI Receives: Procedure: Transforaminal epidural steroid injection (TFESI) |
| Patients who received limaprost (Opalmon®) after transforaminal epidural steroid injection | Experimental | Patients who took limaprost (Opalmon®) for 12 weeks after TFESI Receives: Procedure: Transforaminal epidural steroid injection (TFESI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODI (Oswestry Disability Index) change
The change in ODI compared to the baseline was measured at the outpatient visit.
Measured: 4 weeks after placebo or limaprost (Opalmon®)
Secondary outcomes (15)
ODI (Oswestry Disability Index) change
The change in ODI compared to the baseline was measured at the outpatient visit.
Measured: 8 weeks after placebo or limaprost (Opalmon®)
ODI (Oswestry Disability Index) change
The change in ODI compared to the baseline was measured at the outpatient visit.
Measured: 12 weeks after placebo or limaprost (Opalmon®)
Treadmill test change
The change in treadmill test compared to the baseline was measured at the outpatient visit.
Measured: 4 weeks after placebo or limaprost (Opalmon®)
Treadmill test change
The change in treadmill test compared to the baseline was measured at the outpatient visit.
Measured: 8 weeks after placebo or limaprost (Opalmon®)
Treadmill test change
The change in treadmill test compared to the baseline was measured at the outpatient visit.
Measured: 12 weeks after placebo or limaprost (Opalmon®)
Numeric Rating Scale (NRS) change
The change in NRS compared to the baseline was measured at the outpatient visit.
Measured: 4 weeks after placebo or limaprost (Opalmon®)
Numeric Rating Scale (NRS) change
The change in NRS compared to the baseline was measured at the outpatient visit.
Measured: 8 weeks after placebo or limaprost (Opalmon®)
Numeric Rating Scale (NRS) change
The change in NRS compared to the baseline was measured at the outpatient visit.
Measured: 12 weeks after placebo or limaprost (Opalmon®)
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
The change in EQ-5D compared to the baseline was measured at the outpatient visit.
Measured: 4 weeks after placebo or limaprost (Opalmon®)
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
The change in EQ-5D compared to the baseline was measured at the outpatient visit.
Measured: 8 weeks after placebo or limaprost (Opalmon®)
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
The change in EQ-5D compared to the baseline was measured at the outpatient visit.
Measured: 12 weeks after placebo or limaprost (Opalmon®)
Beck Depression Inventory (BPI) change
The change in BPI compared to the baseline was measured at the outpatient visit.
Measured: 4 weeks after placebo or limaprost (Opalmon®)
Beck Depression Inventory (BPI) change
The change in BPI compared to the baseline was measured at the outpatient visit.
Measured: 8 weeks after placebo or limaprost (Opalmon®)
Beck Depression Inventory (BPI) change
The change in BPI compared to the baseline was measured at the outpatient visit.
Measured: 12 weeks after placebo or limaprost (Opalmon®)
Changes in analgesic drugs
The change in analgesic drugs compared to the baseline was measured at the outpatient visit.
Measured: 12 weeks after placebo or limaprost (Opalmon®)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start10 Nov 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
- Investigators
- Youn Moon Jee, MD, PhD, Study director, Seoul National University HospitalJeongsoo Kim, MD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876612
- Sponsor's protocol ID
- 2102-086-119
- Status last verified
- May 2024
- First submitted
- 3 May 2021
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection for the Treatment of Lumbar Spinal Stenosis: a Prospective, Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04876612
- Acronym / sponsor ID
- 2102-086-119
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the effects of limaprost(Opalmon® ) on walking ability, low back pain and leg pain after transforaminal epidural steroid injection (TFESI) was administered compared to the placebo group.
Detailed description
This study is a prospective, randomized, comparative clinical study that is assigned to a placebo group or a trial group before transforaminal epidural steroid injection (TFESI) is performed.
The subjects of the study will receive an explanation of the study and decide to participate voluntarily in patients who have decided to undergo TFESI for neurogenic claudication and low back pain or leg pain due to lumbar spinal canal stenosis (LSS).
All study subjects are presented with TFESI at the level appropriate for their symptoms in the operating room and then returned to the recovery room. All participants will be monitored for non-invasive blood pressure, electrocardiography, heart rate, and peripheral oxyven saturation during and after the procedure.
Patients assigned to the placebo group will take placebo three times a day and one tablet once from the first day after receiving TFESI. Patients assigned to the trial group will take limaprost (Opalmon®) three times a day, one tablet once from the first day after receiving TFESI. In both groups, the drug was administered for 12 weeks.
In both groups, during the first 4 weeks, no drug changes or additional procedures were observed, and only Acetaminophen was allowed as a rescue drug.
After TFESI, visits at 4 weeks, 8 weeks and 12 weeks to collect each measurement variable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who received placebo after transforminal epidural steroid injection | Placebo comparator | Procedure: Transforaminal epidural steroid injection (TFESI)Patients who took placebo for 12 weeks after TFESI |
| Patients who received limaprost (Opalmon®) after transforaminal epidural steroid injection | Experimental | Procedure: Transforaminal epidural steroid injection (TFESI)Patients who took limaprost (Opalmon®) for 12 weeks after TFESI |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 85 years
- Patients with a new or known diagnosis of lumbar spinal stenosis on Magnetic Resonance Imaging (MRI)
- Patients scheduled to undergo TFESI due to low back pain or leg pain
Key exclusion criteria (15 listed)
- Refusal of a patient
- Coagulopathy
- Systemic infection or local infection at the needle injection site
- Patients with lumbar instability
- Neoplasms in the needle path
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transforaminal epidural steroid injection (TFESI)Well trained pain physician performs all the fluoroscopy-guided transforaminal epidural steroid injection (TFESI), who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For TFESI, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under fluoroscopy guidance at the patient's symptom complaining level. After confirming with a contrast medium, 3 ml of 0.1875% ropivacaine and 5 mg of dexamethasone are administered. | Procedure or surgery | Patients who received limaprost (Opalmon®) after transforaminal epidural steroid injection, Patients who received placebo after transforminal epidural steroid injection |
Primary outcome
ODI (Oswestry Disability Index) change
Time frame: 4 weeks after placebo or limaprost (Opalmon®)
The change in ODI compared to the baseline was measured at the outpatient visit.
15 secondary outcomes
ODI (Oswestry Disability Index) change
Time frame: 8 weeks after placebo or limaprost (Opalmon®)
ODI (Oswestry Disability Index) change
Time frame: 12 weeks after placebo or limaprost (Opalmon®)
Treadmill test change
Time frame: 4 weeks after placebo or limaprost (Opalmon®)
Treadmill test change
Time frame: 8 weeks after placebo or limaprost (Opalmon®)
Treadmill test change
Time frame: 12 weeks after placebo or limaprost (Opalmon®)
Numeric Rating Scale (NRS) change
Time frame: 4 weeks after placebo or limaprost (Opalmon®)
Numeric Rating Scale (NRS) change
Time frame: 8 weeks after placebo or limaprost (Opalmon®)
Numeric Rating Scale (NRS) change
Time frame: 12 weeks after placebo or limaprost (Opalmon®)
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
Time frame: 4 weeks after placebo or limaprost (Opalmon®)
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
Time frame: 8 weeks after placebo or limaprost (Opalmon®)
Euroqol-5 Dimensions Questionnaire (EQ-5D) change
Time frame: 12 weeks after placebo or limaprost (Opalmon®)
Beck Depression Inventory (BPI) change
Time frame: 4 weeks after placebo or limaprost (Opalmon®)
Beck Depression Inventory (BPI) change
Time frame: 8 weeks after placebo or limaprost (Opalmon®)
Beck Depression Inventory (BPI) change
Time frame: 12 weeks after placebo or limaprost (Opalmon®)
Changes in analgesic drugs
Time frame: 12 weeks after placebo or limaprost (Opalmon®)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youn Moon Jee, MD, PhD study director
Seoul National University Hospital
Jeongsoo Kim, MD principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transforaminal epidural steroid injection (TFESI) in people with Lumbar Spinal Stenosis, run by Seoul National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youn Moon Jee, MD, PhD (821052992036, jymoon0901@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODI (Oswestry Disability Index) change (time frame: 4 weeks after placebo or limaprost (Opalmon®)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.