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Comparison of Transforaminal vs. Parasagittal Interlaminar Epidural Injection

NCT ID: NCT02838615

Last Updated: 2017-11-29

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-06-30

Brief Summary

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The purpose of this study is to compare the clinical efficacy, incidence of ventral epidural spreading and provocation of concordant paresthesia, amount of radiation exposure and total procedure time between transforaminal and parasagittal interlaminar epidural injection.

Detailed Description

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Participants were randomly allocated to receive either parasagittal interlaminar or transforaminal ESI.

Investigators obtained clinical data including age, gender, duration of symptoms, predominant symptoms (axial pain vs. leg pain), severity of neurogenic intermittent claudication (NIC) and degree of depression. Depression was assessed by the Korean version of the Beck Depression Inventory (BDI). The BDI is a standardized questionnaire to assess cognitive, affective, and somatic symptoms of depression. All data were obtained before performing ESI.Data about anterior epidural spreading and presence of concordant pain provocation were obtained during fluoroscopic guided parasagittal interlaminar or transforaminal ESI. Also total procedure time and amount of radiation exposure were checked. Investigators observed the epidural spread pattern after a 2 ml injection of contrast material, confirmed anterior epidural spread with a lateral view, and asked the participants if they had any concordant pain provocation or not. The participants were asked if the pain was in the same distribution as their original pain (concordant) or dissimilar or absent in both quality and location.

Investigators used the numerical rating scale (NRS) as well as the Korean version of the Oswestry Disability Index (ODI) to evaluate clinical efficacy in terms of reducing pain and functional improvement at pretreatment and 2 weeks after the ESI series. ESI was performed twice with a 2 weeks interval before the final treatment outcome evaluation with the NRS and ODI. All patients reported average severity of their symptoms over the previous 1 week. A score of 0 on the NRS represents no pain, and a score of 10 represents the worst pain imaginable. The Korean version of the ODI (0-50) was used to assess functional improvement.

Conditions

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Spinal Stenosis

Keywords

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spinal stenosis epidural steroid injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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epidural steroid injection

TF epidural steroid (dexamethasone) injection

Group Type ACTIVE_COMPARATOR

epidural steroid (dexamethasone) injection

Intervention Type PROCEDURE

spinal injections performed in epidural space to relieve chronic low back pain or leg pain

IL epidural steroid injection

PS interlaminar epidural steroid(dexamethasone) injection

Group Type ACTIVE_COMPARATOR

epidural steroid (dexamethasone) injection

Intervention Type PROCEDURE

spinal injections performed in epidural space to relieve chronic low back pain or leg pain

Interventions

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epidural steroid (dexamethasone) injection

spinal injections performed in epidural space to relieve chronic low back pain or leg pain

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* central spinal stenosis
* herniated nucleus pulposus.

Exclusion Criteria

* Lateral spinal stenosis
* Internal disc disruption
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ji Hee Hong

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2016-05-029

Identifier Type: -

Identifier Source: org_study_id