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

NCT01885481 | Completed DMC

• 1 other identifier: B-1304-199-001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Back Pain; Neck Pain

Keywords

dexamethasone; betamethasone; epidural steroid injection; comparative effectiveness research

Outcome Measures

Primary Outcomes (1)

• the proportion of patients with pain improvement

  the proportion of patients with significant pain improvement at 2 week after epidural steroid injection, with the patients' subjective satisfaction scale of "much improved" or "no pain"

  baseline and 2 weeks

Secondary Outcomes (3)

• incidence of adverse events

  during 12 weeks after epidural steroid injection

• pain relief

  baseline and 2 weeks

• disability improvement

  baseline and 2 weeks

Study Arms (2)

ESI-1

ACTIVE COMPARATOR

epidural steroid injection using dexamethasone

Drug: Dexamethasone

ESI-2

EXPERIMENTAL

epidural steroid injection using betamethasone

Drug: Betamethasone

Interventions

Dexamethasone DRUG

epidural steroid injection using dexamethasone

Also known as: dexamethasone-ESI

ESI-1

Betamethasone DRUG

epidural steroid injection using betamethasone

Also known as: betamethasone-ESI

ESI-2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• age of patient less than 19 years
• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 763-707, South Korea

Location

MeSH Terms

Conditions

Back Pain; Neck Pain

Interventions

Dexamethasone; Betamethasone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Joon Woo Lee, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Department of Radiology

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 25, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 30, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)