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NCT Number: NCT01885481

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

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.

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Key information

Conditions

Back Pain Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 763-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

epidural steroid injection using dexamethasone

Other names: dexamethasone-ESI

Betamethasone

Drug

epidural steroid injection using betamethasone

Other names: betamethasone-ESI

Primary outcomes

  1. the proportion of patients with pain improvement

    Time frame: 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 outcomes

  1. incidence of adverse events

    Time frame: during 12 weeks after epidural steroid injection

    incidence of adverse event during 12 weeks after epidural steroid injection

  2. pain relief

    Time frame: 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

  3. disability improvement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2013
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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