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

Low Back Pain Clinical Trial

Official title:

Comparison Between Endoscopic Epidural Neuroplasty and Percutaneous Epidural Neuroplasty With a Steering Catheter in Low Back and Radicular Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05533723
• Other study ID #: AJIRB-MED-MDB-20-53
• Status: Completed
• Start date: October 10, 2018
• Est. completion date: August 24, 2022

Study information

• Verified date: September 2022
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Low Back Pain
• Radiculopathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyunggi

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale	11 points pain scale score from 0 to 10	6 months after EEN or PEN
Primary	Oswestry disability index	disability index from 0 to 100%	6 months after EEN or PEN
Secondary	weight	kg	before EEN or PEN
Secondary	height	m	before EEN or PEN