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

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885481
• Other study ID #: B-1304-199-001
• Status: Completed
• Phase: N/A
• First received: June 20, 2013
• Last updated: March 28, 2016
• Start date: October 2013
• Est. completion date: April 2015

Study information

• Verified date: March 2016
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Back Pain
• Neck Pain

Intervention

Drug:
• Dexamethasone
epidural steroid injection using dexamethasone
• Betamethasone
epidural steroid injection using betamethasone

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients with pain improvement	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"	baseline and 2 weeks	No
Secondary	incidence of adverse events	incidence of adverse event during 12 weeks after epidural steroid injection	during 12 weeks after epidural steroid injection	Yes
Secondary	pain relief	decrease of visual analog scale (VAS) for pain at 2 week time point after epidural steroid injection, compared to baseline at 0 week	baseline and 2 weeks	No
Secondary	disability improvement	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	baseline and 2 weeks	No