The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Medial vs Lateral in Anteroposterior View

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-29

Study Completion Date

2016-11-28

Brief Summary

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Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial approach and method using lateral approach in anteroposterior view, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.

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Detailed Description

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Conditions

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Lumbosacral Radicular Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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medial approach group

Group Type EXPERIMENTAL

S1 transforaminal epidural steroid(dexamethasone) injection

Intervention Type DRUG

medial approach group (n=85): check intravascular injection while performing S1 transforaminal epidural steroid(dexamethasone) injection in medial side of S1 foramen under fluoroscopy

lateral approach group (n=85): same as medial approach group except using lateral side of S1 foramen

lateral approach group

Group Type ACTIVE_COMPARATOR

S1 transforaminal epidural steroid(dexamethasone) injection

Intervention Type DRUG

medial approach group (n=85): check intravascular injection while performing S1 transforaminal epidural steroid(dexamethasone) injection in medial side of S1 foramen under fluoroscopy

lateral approach group (n=85): same as medial approach group except using lateral side of S1 foramen

Interventions

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S1 transforaminal epidural steroid(dexamethasone) injection

medial approach group (n=85): check intravascular injection while performing S1 transforaminal epidural steroid(dexamethasone) injection in medial side of S1 foramen under fluoroscopy

lateral approach group (n=85): same as medial approach group except using lateral side of S1 foramen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at pain management clinic

Exclusion Criteria

1. pregnancy
2. coagulopathy
3. systemic infection
4. any active infection at the injection site
5. history of allergy to contrast media, local anesthetics, corticosteroid
6. patients unable to communicate or patients with cognitive dysfunction

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No