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

Primary Purpose

Back Pain, Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexamethasone
Betamethasone
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring dexamethasone, betamethasone, epidural steroid injection, comparative effectiveness research

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ESI-1

ESI-2

Arm Description

epidural steroid injection using dexamethasone

epidural steroid injection using betamethasone

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

incidence of adverse events
incidence of adverse event during 12 weeks after epidural steroid injection
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
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

Full Information

First Posted
June 20, 2013
Last Updated
March 28, 2016
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01885481
Brief Title
Evaluation of Efficacy and Safety of Epidural Steroid Injection Using Dexamethasone or Betamethasone
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Neck Pain
Keywords
dexamethasone, betamethasone, epidural steroid injection, comparative effectiveness research

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESI-1
Arm Type
Active Comparator
Arm Description
epidural steroid injection using dexamethasone
Arm Title
ESI-2
Arm Type
Experimental
Arm Description
epidural steroid injection using betamethasone
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
dexamethasone-ESI
Intervention Description
epidural steroid injection using dexamethasone
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Other Intervention Name(s)
betamethasone-ESI
Intervention Description
epidural steroid injection using betamethasone
Primary Outcome Measure Information:
Title
the proportion of patients with pain improvement
Description
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"
Time Frame
baseline and 2 weeks
Secondary Outcome Measure Information:
Title
incidence of adverse events
Description
incidence of adverse event during 12 weeks after epidural steroid injection
Time Frame
during 12 weeks after epidural steroid injection
Title
pain relief
Description
decrease of visual analog scale (VAS) for pain at 2 week time point after epidural steroid injection, compared to baseline at 0 week
Time Frame
baseline and 2 weeks
Title
disability improvement
Description
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
Time Frame
baseline and 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon Woo Lee, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
763-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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