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

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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

  • 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..)

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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