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

Seoul National University

Status: Completed

Conditions: Back Pain; Neck Pain

Treatments: Drug: Dexamethasone; Drug: Betamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01885481

B-1304-199-001

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

ESI-1

Active Comparator group

Description:

epidural steroid injection using dexamethasone

Treatment:

Drug: Dexamethasone

ESI-2

Experimental group

Description:

epidural steroid injection using betamethasone

Treatment:

Drug: Betamethasone