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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01885481
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Joon Woo Lee, Seoul National University Bundang Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Back Pain Neck Pain Drug: Dexamethasone Drug: Betamethasone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ESI-1
epidural steroid injection using dexamethasone
 Drug: Dexamethasone
epidural steroid injection using dexamethasone
Other Name: dexamethasone-ESI
Experimental: ESI-2
epidural steroid injection using betamethasone
 Drug: Betamethasone
epidural steroid injection using betamethasone
Other Name: betamethasone-ESI


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885481


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 763-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Joon Woo Lee, MD Seoul National University Bundang Hospital
More Information
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Responsible Party: Joon Woo Lee, Associate professor, Department of Radiology, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01885481    
Other Study ID Numbers: B-1304-199-001
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joon Woo Lee, Seoul National University Bundang Hospital:
dexamethasone
betamethasone
epidural steroid injection
comparative effectiveness research
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Dexamethasone
Dexamethasone acetate
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Asthmatic Agents
Respiratory System Agents