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

NCT ID: NCT05533723

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 107 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2022-08-24

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.

Conditions

Low Back Pain; Radiculopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Percutaneous epidural neuroplasty (PEN)

Intervention Type: PROCEDURE

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.

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.

Endoscopic epidural neuroplasty

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Percutaneous epidural neuroplasty (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

• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jong Bum Choi

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jong Bum Choi

Role: STUDY_DIRECTOR

Ajou University School of Medicine

Locations

Ajou University Hospital

Suwon, Gyunggi, South Korea

Countries

South Korea

Other Identifiers

AJIRB-MED-MDB-20-53

Identifier Type: -

Identifier Source: org_study_id