An observational study in Low Back Pain and Radiculopathy, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2022-09-09.
Sponsored by Ajou University School of Medicine · Observational
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.
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.
488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.
This study's enrollment of 107 is above the median of 93 across 98 observational studies indexed under Radiculopathy.
Browse Radiculopathy studies →Ajou University School of Medicine is the lead sponsor of 171 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who visited Ajou University Hospital pain clinic with back and radiating pain from 2016 to 2020
Exclusion Criteria:
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.
Procedure: Percutaneous epidural neuroplasty (PEN)
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.
Procedure: Endoscopic epidural neuroplasty
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.
Also known as: 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.
visual analog scale
11 points pain scale score from 0 to 10
Time frame: 6 months after EEN or PEN
Oswestry disability index
disability index from 0 to 100%
Time frame: 6 months after EEN or PEN
weight
kg
Time frame: before EEN or PEN
height
m
Time frame: before EEN or PEN
Plan to share: No
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Ajou University School of Medicine