Spinal StenosisNCT02597244
Effectiveness of Percutaneous Foraminotomy
A study testing Percutaneous Extraforaminotomy in people with Spinal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea), was performed in patients who did not show improvement lasting more than 1 month after diagnostic conventional fluoroscopically guided transforaminal epidural block with local anesthetic and steroid. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Percutaneous Extraforaminotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Jan 2016
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- radicular pain with positive provocation factors > 3 months
- Radicular pain at L4 or L5
- Presence of dominant side when bilateral symptom present
- Positive provocation factors: leg symptoms elicited or aggravated by walking but relieved by sitting down
- Not appropriate relief of pain routinely conservative treatment (physiotherapy, exercise, analgesic medication, epidural steroid injection) > 3 months
- Magnetic resonance imaging(MRI) : Foraminal stenosis of Grade 1-3 (foraminal herniated intervertebral disc(HIVD) with mild to severe degree of foraminal stenosis according to AJR:194, April 2010 by Lee, et. Al)
- Subjects who signed for the consent form
Who cannot join
- Acute back or leg pain
- Sings of progressive neurologic deficits, including muscle atrophy and abnormal tendon reflexes
- Patients with a history of prior spine surgery
- Allergic response to steroid or contrast dye
- Bleeding diathesis or over coagulopathy
- Patients with bilateral radiculopathy or spinal stenosis at more than 3 levels
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Sangchul Lee, MD, PhD, +82-2-2072-2248, pain8275@gmail.com
Sangchul Lee, MD, PhD
About this study
Official title: Effectiveness of Percutaneous Foraminotomy in Patients With Lumbar Foraminal Stenosis: A Prospective, Pilot Study
Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea), was performed in patients who did not show improvement lasting more than 1 month after diagnostic conventional fluoroscopically guided transforaminal epidural block with local anesthetic and steroid.
Numeric rating scale(NRS) pain score, Oswestry disability index (ODI), Roland-Morris Disability Questionnaire (RDQ), claudication distance(CD) was checked before and after the procedure.
Read the detailed description
Percutaneous Extraforaminotomy with Transforaminal Adhesiolysis may be an effective minimal invasive technique in patients not responsive to conventional epidural steroid injection.
- Conditions
- Spinal Stenosis
- Being tested
- Percutaneous Extraforaminotomy
- Keywords
- Lumbar foraminal stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous ExtraforaminotomyDevice
percutaneous dissecting of the lumbar extraforaminal and foraminal region with BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) under fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) Receives: Device: Percutaneous Extraforaminotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS score
A comparison of the mean difference in the change of NRS scores of their leg pain from entry to the scores at 4-week
Measured: 4 weeks after intervention
Secondary outcomes (5)
NRS score
A comparison of the mean difference in the change of NRS scores of their leg pain from entry to the scores at 8, 12-weeks after intervention
Measured: 8, 12 weeks after intervention
Oswestry disability index(ODI)
A change of ODI over periods of time after intervention (12 weeks)
Measured: 4, 8 and 12 weeks after intervention
5-point satisfaction scale
Patient satisfaction with treatment at 4, 8, \& 12 weeks
Measured: 4, 8 and 12 weeks
Any adverse events
Measured: Throughout the study period (up to 12 weeks)
Roland-Morris Disability Questionnaire(RDQ)
A change of RDQ change over periods of time after intervention (12 weeks)
Measured: 4, 8 and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startJun 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BioSpine Co., Ltd.
- Responsible party
- Principal investigator, Sangchul Lee, Seoul National University Hospital
- Investigators
- Sangchul Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597244
- Sponsor's protocol ID
- 0620141940
- Status last verified
- Nov 2015
- First submitted
- 6 Oct 2015
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cooper G, Lutz GE, Boachie-Adjei O, Lin J. Effectiveness of transforaminal epidural steroid injections in patients with degenerative lumbar scoliotic stenosis and radiculopathy. Pain Physician. 2004 Jul;7(3):311-7.
PubMed 16858467
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Percutaneous Foraminotomy in Patients With Lumbar Foraminal Stenosis: A Prospective, Pilot Study
- ClinicalTrials.gov ID
- NCT02597244
- Acronym / sponsor ID
- 0620141940
- Conditions
- Spinal Stenosis
- Keywords
- Lumbar foraminal stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- BioSpine Co., Ltd.
- Study start
- Jun 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- 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.
Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea), was performed in patients who did not show improvement lasting more than 1 month after diagnostic conventional fluoroscopically guided transforaminal epidural block with local anesthetic and steroid.
Numeric rating scale(NRS) pain score, Oswestry disability index (ODI), Roland-Morris Disability Questionnaire (RDQ), claudication distance(CD) was checked before and after the procedure.
Detailed description
Percutaneous Extraforaminotomy with Transforaminal Adhesiolysis may be an effective minimal invasive technique in patients not responsive to conventional epidural steroid injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Percutaneous ExtraforaminotomyPercutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- radicular pain with positive provocation factors > 3 months
- Radicular pain at L4 or L5
- Presence of dominant side when bilateral symptom present
- Positive provocation factors: leg symptoms elicited or aggravated by walking but relieved by sitting down
- Not appropriate relief of pain routinely conservative treatment (physiotherapy, exercise, analgesic medication, epidural steroid injection) > 3 months
Key exclusion criteria (6 listed)
- Acute back or leg pain
- Sings of progressive neurologic deficits, including muscle atrophy and abnormal tendon reflexes
- Patients with a history of prior spine surgery
- Allergic response to steroid or contrast dye
- Bleeding diathesis or over coagulopathy
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 |
|---|---|---|
| Percutaneous Extraforaminotomypercutaneous dissecting of the lumbar extraforaminal and foraminal region with BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) under fluoroscopy | Device | Treatment group |
Primary outcome
NRS score
Time frame: 4 weeks after intervention
A comparison of the mean difference in the change of NRS scores of their leg pain from entry to the scores at 4-week
5 secondary outcomes
NRS score
Time frame: 8, 12 weeks after intervention
Oswestry disability index(ODI)
Time frame: 4, 8 and 12 weeks after intervention
5-point satisfaction scale
Time frame: 4, 8 and 12 weeks
Any adverse events
Time frame: Throughout the study period (up to 12 weeks)
Roland-Morris Disability Questionnaire(RDQ)
Time frame: 4, 8 and 12 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Results publication: PubMed 16858467Cooper G, Lutz GE, Boachie-Adjei O, Lin J. Effectiveness of transforaminal epidural steroid injections in patients with degenerative lumbar scoliotic stenosis and radiculopathy. Pain Physician. 2004 Jul;7(3):311-7.
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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.
Sangchul Lee, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Extraforaminotomy in people with Spinal Stenosis, run by Seoul National University Hospital 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 7 inclusion and 6 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 5 Nov 2015. 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. 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 Sangchul Lee, MD, PhD (+82-2-2072-2248, pain8275@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS score (time frame: 4 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597244, which also lists 1 linked publication.
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 5 Nov 2015.