Evaluation of Efficacy and Safety of Epidural Steroid Injection Using Dexamethasone or Betamethasone

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

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-04-30

Brief Summary

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Particle steroid drug such as triamcinolone has been used widely for epidural steroid injection (ESI) treatment in Korea. However, Korea FDA recently prohibit ESI using triamcinolone, following the regulation of US FDA. Therefore, dexamethasone and betamethasone become only candidate drugs for ESI in Korea and the investigators are curious about the effectiveness and safety of both drugs due to limitation of information about comparison of two drugs in previous literature. So, this study aims to compare the effectiveness and safety of both drugs and our hypothesis is that there is no difference of the effectiveness between dexamethasone and betamethasone at 2 weeks after ESI.

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Detailed Description

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Conditions

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Back Pain Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ESI-1

epidural steroid injection using dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

epidural steroid injection using dexamethasone

ESI-2

epidural steroid injection using betamethasone

Group Type EXPERIMENTAL

Betamethasone

Intervention Type DRUG

epidural steroid injection using betamethasone

Interventions

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Dexamethasone

epidural steroid injection using dexamethasone

Intervention Type DRUG

Betamethasone

epidural steroid injection using betamethasone

Intervention Type DRUG

Other Intervention Names

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dexamethasone-ESI betamethasone-ESI

Eligibility Criteria

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Inclusion Criteria

1. patients with spinal pain (i.e.neck pain, back pain, or radiculopathy..)
2. patients with informed consent
3. visual analog scale (VAS) is five or more in 10-point scale at screening
4. sustained spinal pain, regardless of sufficient conservative treatment (i.e. oral medicine, physical therapy..)

Exclusion Criteria

1. age of patient less than 19 years
2. relative contraindication of epidural steroid injection, as follows:

* pregnant or breast-feeding state
* uncontrolled coagulopathy
* suspected of active infection state
* uncontrolled diabetes mellitus
* previous history of adverse event related to epidural steroid injection

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No