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

Study Overview
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Brief Summary
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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
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Evaluation of Efficacy and Safety of Epidural Steroid Injection Using Dexamethasone or Betamethasone in Patients With Spinal Pain: a Prospective, Randomized, Double-blind Study

Conditions
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Back Pain, Neck Pain

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Betamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESI-1<br>epidural steroid injection using dexamethasone | Drug: Dexamethasone<br>* epidural steroid injection using dexamethasone<br>* Other names: dexamethasone-ESI;|
| Experimental: ESI-2<br>epidural steroid injection using betamethasone | Drug: Betamethasone<br>* epidural steroid injection using betamethasone<br>* Other names: betamethasone-ESI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse events | incidence of adverse event during 12 weeks after epidural steroid injection | 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 | baseline and 2 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexamethasone, betamethasone, epidural steroid injection, comparative effectiveness research