Comparison Between Endoscopic Epidural Neuroplasty and Percutaneous Epidural Neuroplasty in Low Back and Radicular Pain

Completed

• Conditions: Low Back Pain; Radiculopathy
• Interventions: Procedure: Endoscopic epidural neuroplasty; Procedure: Percutaneous epidural neuroplasty (PEN)

• Registration Number: NCT05533723
• Lead Sponsor: Ajou University School of Medicine

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.

Study Timeline

• Study Start: 2018-10-10
• Study First Submitted: 2022-08-23
• Primary Completion: 2022-08-24
• Study Completion: 2022-08-24
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-07
• Last Update Submitted: 2022-09-07
• Study First Posted: 2022-09-09
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 107

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic epidural neuroplasty (EEN) group	Endoscopic epidural neuroplasty	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.
Percutaneous epidural neuroplasty (PEN) group	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.

Primary Outcome Measures

Name	Time	Method
visual analog scale	6 months after EEN or PEN	11 points pain scale score from 0 to 10
Oswestry disability index	6 months after EEN or PEN	disability index from 0 to 100%

Secondary Outcome Measures

Name	Time	Method
height	before EEN or PEN	m
weight	before EEN or PEN	kg

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Gyunggi, Korea, Republic of