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

Overview

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.

Full Title of Study: “Evaluation of Efficacy and Safety of Epidural Steroid Injection Using Dexamethasone or Betamethasone in Patients With Spinal Pain: a Prospective, Randomized, Double-blind Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 2015

Interventions

  • Drug: Dexamethasone
    • epidural steroid injection using dexamethasone
  • Drug: Betamethasone
    • epidural steroid injection using betamethasone

Arms, Groups and Cohorts

  • Active Comparator: ESI-1
    • epidural steroid injection using dexamethasone
  • Experimental: ESI-2
    • epidural steroid injection using betamethasone

Clinical Trial Outcome Measures

Primary Measures

  • the proportion of patients with pain improvement
    • Time Frame: baseline and 2 weeks
    • 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”

Secondary Measures

  • incidence of adverse events
    • Time Frame: during 12 weeks after epidural steroid injection
    • incidence of adverse event during 12 weeks after epidural steroid injection
  • pain relief
    • Time Frame: baseline and 2 weeks
    • decrease of visual analog scale (VAS) for pain at 2 week time point after epidural steroid injection, compared to baseline at 0 week
  • disability improvement
    • Time Frame: baseline and 2 weeks
    • decrease of disability index (Oswestry disability index or Neck disability index) for pain at 2 week time point after epidural steroid injection, compared to baseline at 0 week

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Bundang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joon Woo Lee, Associate professor, Department of Radiology – Seoul National University Bundang Hospital
  • Overall Official(s)
    • Joon Woo Lee, MD, Principal Investigator, Seoul National University Bundang Hospital

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