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

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01885481

Collaborator

(none)

600

Enrollment

Location

Arms

Duration (Months)

33.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Back Pain Neck Pain	Drug: Dexamethasone Drug: Betamethasone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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 Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ESI-1 epidural steroid injection using dexamethasone	Drug: Dexamethasone epidural steroid injection using dexamethasone Other Names: dexamethasone-ESI
Experimental: ESI-2 epidural steroid injection using betamethasone	Drug: Betamethasone epidural steroid injection using betamethasone Other Names: betamethasone-ESI

Arm

Intervention/Treatment

Active Comparator: ESI-1

epidural steroid injection using dexamethasone

Drug: Dexamethasone

epidural steroid injection using dexamethasone

Other Names:

dexamethasone-ESI

Experimental: ESI-2

epidural steroid injection using betamethasone

Drug: Betamethasone

epidural steroid injection using betamethasone

Other Names:

betamethasone-ESI

Outcome Measures

Primary Outcome Measures

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

incidence of adverse events [during 12 weeks after epidural steroid injection]
incidence of adverse event during 12 weeks after epidural steroid injection
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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..)