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

Not Applicable

Completed

• Conditions: Back Pain; Neck Pain
• Interventions: Drug: Dexamethasone; Drug: Betamethasone

• Registration Number: NCT01885481
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-25
• Study Start: 2013-10
• Primary Completion: 2015-02
• Study Completion: 2015-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ESI-1	Dexamethasone	epidural steroid injection using dexamethasone
ESI-2	Betamethasone	epidural steroid injection using betamethasone

Primary Outcome Measures

Name	Time	Method
the proportion of patients with pain improvement	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 Outcome Measures

Name	Time	Method
incidence of adverse events	during 12 weeks after epidural steroid injection	incidence of adverse event during 12 weeks after epidural steroid injection
disability improvement	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
pain relief	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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of