Low Back PainNCT05533723
Comparison Between Endoscopic Epidural Neuroplasty and Percutaneous Epidural Neuroplasty in Low Back and Radicular Pain
An observational study of Low Back Pain and Radiculopathy, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
PEN(percutaneous epidural neuroplasty) can be performed percutaneously, may be manipulated to mechanically break up adhesions by catheter, while various agents, such as anesthetics, corticosteroids, hyaluronidase, and hypertonic saline are injected. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Back Pain, Radiculopathy
- What is being tested?
- Endoscopic epidural neuroplasty and Percutaneous epidural neuroplasty (PEN)
- Type of treatment
- Surgery or procedure
- How many people
- 107 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Oct 2018to 24 Aug 2022
- Phase
- Observational
- 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 Any age
- Child, Adult, Older adult
Study population: Patients who visited Ajou University Hospital pain clinic with back and radiating pain from 2016 to 2020
Who may be able to join
- age over 20 years
- low back or radicular pain in the low extremities
- persistent low back or radicular pain
Who cannot join
- systemic infection
- skin infection at the injection site
- uncontrolled diabetes mellitus
- coagulation abnormalities
- history of allergic reactions to local anesthetics or contrast agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Endoscopic Epidural Neuroplasty and Percutaneous Epidural Neuroplasty With a Steering Catheter in Low Back and Radicular Pain
PEN(percutaneous epidural neuroplasty) can be performed percutaneously, may be manipulated to mechanically break up adhesions by catheter, while various agents, such as anesthetics, corticosteroids, hyaluronidase, and hypertonic saline are injected. In endoscopic epidural neuroplasty (EEN), a flexible catheter is inserted into the sacral hiatus to precisely place the injection in the epidural space and onto the nerve root. Both EEN and PEN can eliminate the deleterious effects of scar formation, which can physically prevent the direct application of drugs to the nerves, and may provide pain relief in patients who have not responded to epidural blocks, physical therapy, or medication. In this study, visual analog scale (VAS) and Oswestry disability index (ODI) of patients with low back and radicular pain were compared in patients who had received EEN or PEN at 1 day, 1 month, and 6 months after EEN or PEN.
Read the detailed description
Low back pain and lumbar radicular pain commonly occur in degenerative spondy-losis. Low back and radicular pain have many underlying causes, one of which is scar-ring in the epidural space, which can cause pain for many reasons. The nerves may be trapped by scars, while the congestive veins in the epidural space can become enlarged and exert pressure upon the nerves.
Percutaneous epidural neuroplasty (PEN) with a wire type catheter, first reported by Dr. Racz, has been widely practiced since 1989, and reduces pain by epidural adhesiolysis, epidural fibrosis and inflammation near the neural tissue.
The PEN procedure is used to dissolve some scar tissue around the entrapped nerves in the epidural space of the spine. PEN can be performed percutaneously, using a Racz catheter. The catheter may be manipulated to mechanically break up adhesions, while various agents, such as anesthetics, corticosteroids, hyaluronidase, and hypertonic saline are injected. In endoscopic epidural neuroplasty (EEN), a flexible catheter is inserted into the sacral hiatus to precisely place the injection in the epidural space and onto the nerve root. Both EEN and PEN can eliminate the deleterious effects of scar formation, which can physically prevent the direct application of drugs to the nerves, and may pro-vide pain relief in patients who have not responded to epidural blocks, physical therapy, or medication.
In this study, visual analog scale (VAS) and Oswestry disability index (ODI) of pa-tients with low back and radicular pain were compared in patients who had received EEN or PEN at 1 day, 1 month, and 6 months after EEN or PEN.
- Conditions
- Low Back Pain, Radiculopathy
- Being tested
- Endoscopic epidural neuroplasty, Percutaneous epidural neuroplasty (PEN)
- Medical subject headings
- Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic epidural neuroplastyProcedure or surgery
Also called Percutaneous epidural neuroplasty (PEN)
EEN catheter, iDolphine S2 (Meta Biomed Co., Ltd, Osong, Korea) was placed in the epidural space through sacral hiatus. EEN was done on the target segments.
During EEN, normal saline was infused into epidural space under epiduroscopic vision. Dexamethasone (5 mg), 0.3% mepivacaine 10 mL, and hyaluronidase (3000 IU) were injected through catheter at the target segments. Holmium-Yag laser was used to cut epidural fibrous bands and for coagulation of epidural bleeding.
Percutaneous epidural neuroplasty (PEN)Procedure or surgery
PEN catheter, EDEN-CC (JMT, Yangju, Korea) was placed in the epidural space and neural foramen . PEN was done on the target segments. Dexamethasone (5 mg), 0.3% mepivacaine 10 ml, and hyaluronidase (3000 IU) were injected through the PEN catheter.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous epidural neuroplasty (PEN) group | Patients over 20 years of age with radiating pain in the lower back and legs who received PEN in patients who did not respond to medication and epidural nerve block treatment. Receives: Procedure: Percutaneous epidural neuroplasty (PEN) | |
| Endoscopic epidural neuroplasty (EEN) group | Patients over 20 years of age with radiating pain in the lower back and legs who received EEN in patients who did not respond to medication and epidural nerve block treatment. Receives: Procedure: Endoscopic epidural neuroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
11 points pain scale score from 0 to 10
Measured: 6 months after EEN or PEN
Oswestry disability index
disability index from 0 to 100%
Measured: 6 months after EEN or PEN
Secondary outcomes (2)
weight
kg
Measured: before EEN or PEN
height
m
Measured: before EEN or PEN
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start10 Oct 2018
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Bum Choi, Ajou University School of Medicine
- Investigators
- Jong Bum Choi, Study director, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533723
- Sponsor's protocol ID
- AJIRB-MED-MDB-20-53
- Status last verified
- Sep 2022
- First submitted
- 23 Aug 2022
- Last updated
- 9 Sep 2022
- 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 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Endoscopic Epidural Neuroplasty and Percutaneous Epidural Neuroplasty With a Steering Catheter in Low Back and Radicular Pain
- ClinicalTrials.gov ID
- NCT05533723
- Acronym / sponsor ID
- AJIRB-MED-MDB-20-53
- Conditions
- Low Back Pain, Radiculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 9 Sep 2022 (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.
PEN(percutaneous epidural neuroplasty) can be performed percutaneously, may be manipulated to mechanically break up adhesions by catheter, while various agents, such as anesthetics, corticosteroids, hyaluronidase, and hypertonic saline are injected. In endoscopic epidural neuroplasty (EEN), a flexible catheter is inserted into the sacral hiatus to precisely place the injection in the epidural space and onto the nerve root. Both EEN and PEN can eliminate the deleterious effects of scar formation, which can physically prevent the direct application of drugs to the nerves, and may provide pain relief in patients who have not responded to epidural blocks, physical therapy, or medication. In this study, visual analog scale (VAS) and Oswestry disability index (ODI) of patients with low back and radicular pain were compared in patients who had received EEN or PEN at 1 day, 1 month, and 6 months after EEN or PEN.
Detailed description
Low back pain and lumbar radicular pain commonly occur in degenerative spondy-losis. Low back and radicular pain have many underlying causes, one of which is scar-ring in the epidural space, which can cause pain for many reasons. The nerves may be trapped by scars, while the congestive veins in the epidural space can become enlarged and exert pressure upon the nerves.
Percutaneous epidural neuroplasty (PEN) with a wire type catheter, first reported by Dr. Racz, has been widely practiced since 1989, and reduces pain by epidural adhesiolysis, epidural fibrosis and inflammation near the neural tissue.
The PEN procedure is used to dissolve some scar tissue around the entrapped nerves in the epidural space of the spine. PEN can be performed percutaneously, using a Racz catheter. The catheter may be manipulated to mechanically break up adhesions, while various agents, such as anesthetics, corticosteroids, hyaluronidase, and hypertonic saline are injected. In endoscopic epidural neuroplasty (EEN), a flexible catheter is inserted into the sacral hiatus to precisely place the injection in the epidural space and onto the nerve root. Both EEN and PEN can eliminate the deleterious effects of scar formation, which can physically prevent the direct application of drugs to the nerves, and may pro-vide pain relief in patients who have not responded to epidural blocks, physical therapy, or medication.
In this study, visual analog scale (VAS) and Oswestry disability index (ODI) of pa-tients with low back and radicular pain were compared in patients who had received EEN or PEN at 1 day, 1 month, and 6 months after EEN or PEN.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous epidural neuroplasty (PEN) group | – | Procedure: Percutaneous epidural neuroplasty (PEN)Patients over 20 years of age with radiating pain in the lower back and legs who received PEN in patients who did not respond to medication and epidural nerve block treatment. |
| Endoscopic epidural neuroplasty (EEN) group | – | Procedure: Endoscopic epidural neuroplastyPatients over 20 years of age with radiating pain in the lower back and legs who received EEN in patients who did not respond to medication and epidural nerve block treatment. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who visited Ajou University Hospital pain clinic with back and radiating pain from 2016 to 2020
Key inclusion criteria (3 listed)
- age over 20 years
- low back or radicular pain in the low extremities
- persistent low back or radicular pain
Key exclusion criteria (5 listed)
- systemic infection
- skin infection at the injection site
- uncontrolled diabetes mellitus
- coagulation abnormalities
- history of allergic reactions to local anesthetics or contrast agents
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 |
|---|---|---|
| Endoscopic epidural neuroplastyAlso: Percutaneous epidural neuroplasty (PEN)EEN catheter, iDolphine S2 (Meta Biomed Co., Ltd, Osong, Korea) was placed in the epidural space through sacral hiatus. EEN was done on the target segments. During EEN, normal saline was infused into epidural space under epiduroscopic vision. Dexamethasone (5 mg), 0.3% mepivacaine 10 mL, and hyaluronidase (3000 IU) were injected through catheter at the target segments. Holmium-Yag laser was used to cut epidural fibrous bands and for coagulation of epidural bleeding. | Procedure or surgery | Endoscopic epidural neuroplasty (EEN) group |
| Percutaneous epidural neuroplasty (PEN)PEN catheter, EDEN-CC (JMT, Yangju, Korea) was placed in the epidural space and neural foramen . PEN was done on the target segments. Dexamethasone (5 mg), 0.3% mepivacaine 10 ml, and hyaluronidase (3000 IU) were injected through the PEN catheter. | Procedure or surgery | Percutaneous epidural neuroplasty (PEN) group |
Primary outcome
visual analog scale
Time frame: 6 months after EEN or PEN
11 points pain scale score from 0 to 10
Oswestry disability index
Time frame: 6 months after EEN or PEN
disability index from 0 to 100%
2 secondary outcomes
weight
Time frame: before EEN or PEN
height
Time frame: before EEN or PEN
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Jong Bum Choi study director
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Radiculopathy, run by Ajou University School of Medicine 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 5 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: finished, as of the sponsor's last update on 9 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (time frame: 6 months after EEN or PEN). The study lists 2 primary outcomes in all. 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 9 Sep 2022.