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

NCT05533723 | Completed

• 1 other identifier: AJIRB-MED-MDB-20-53
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Radiculopathy

Outcome Measures

Primary Outcomes (2)

• visual analog scale

  11 points pain scale score from 0 to 10

  6 months after EEN or PEN

• Oswestry disability index

  disability index from 0 to 100%

  6 months after EEN or PEN

Secondary Outcomes (2)

• weight

  before EEN or PEN

• height

  before EEN or PEN

Study Arms (2)

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.

Procedure: Percutaneous epidural neuroplasty (PEN)

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.

Procedure: Endoscopic epidural neuroplasty

Interventions

Endoscopic epidural neuroplasty 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.

Also known as: Percutaneous epidural neuroplasty (PEN)

Endoscopic epidural neuroplasty (EEN) group

Percutaneous epidural neuroplasty (PEN) 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.

Percutaneous epidural neuroplasty (PEN) group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who visited Ajou University Hospital pain clinic with back and radiating pain from 2016 to 2020

You may qualify if:

• age over 20 years
• low back or radicular pain in the low extremities
• persistent low back or radicular pain

You may not qualify if:

• systemic infection
• skin infection at the injection site
• uncontrolled diabetes mellitus
• coagulation abnormalities
• history of allergic reactions to local anesthetics or contrast agents

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyunggi, 16499, South Korea

Location

MeSH Terms

Conditions

Low Back Pain; Radiculopathy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Jong Bum Choi

  Ajou University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 9, 2022
• Study Start: October 10, 2018
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)