Clinical trial NCT05533723: Comparison Between Endoscopic Epidural Neuroplasty and Percutaneous Epidural Neuroplasty in Low Back and Radicular Pain
Official title: Comparison Between Endoscopic Epidural Neuroplasty and Percutaneous Epidural Neuroplasty With a Steering Catheter in Low Back and Radicular Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Radiculopathy
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 107
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visited Ajou University Hospital pain clinic with back and radiating pain from 2016 to 2020

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. age over 20 years
2. low back or radicular pain in the low extremities
3. persistent low back or radicular pain

Exclusion Criteria:

1. systemic infection
2. skin infection at the injection site
3. uncontrolled diabetes mellitus
4. coagulation abnormalities
5. history of allergic reactions to local anesthetics or contrast agents

Primary outcomes:
measure: visual analog scale
timeFrame: 6 months after EEN or PEN
measure: Oswestry disability index
timeFrame: 6 months after EEN or PEN
Secondary outcomes:
measure: weight
timeFrame: before EEN or PEN
measure: height
timeFrame: before EEN or PEN
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyunggi
Study officials:
affiliation: Ajou University School of Medicine
name: Jong Bum Choi
role: STUDY_DIRECTOR
References: