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

Condition(s) targeted: Back Pain; Neck Pain

Intervention: Dexamethasone (Drug); Betamethasone (Drug)

Phase: N/A

Status: Completed

Sponsored by: Seoul National University Bundang Hospital

Official(s) and/or principal investigator(s):
Joon Woo Lee, MD, Principal Investigator, Affiliation: Seoul National University Bundang Hospital

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: rate of patients with pain improvement

Secondary outcome:

incidence of adverse events

pain decrease

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. patients with spinal pain (i. e.neck pain, back pain, or radiculopathy..) 2. patients with informed consent 3. VAS (visual analog scale) 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

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do 763-707, Korea, Republic of

Starting date: October 2013
Last updated: May 20, 2015