Back Pain, Neck Pain
Conditions
Keywords
dexamethasone, betamethasone, epidural steroid injection, comparative effectiveness research
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.
Interventions
DRUGDexamethasone
epidural steroid injection using dexamethasone
DRUGBetamethasone
epidural steroid injection using betamethasone
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the proportion of patients with pain improvement | 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
| Measure | Time frame | Description |
|---|---|---|
| incidence of adverse events | during 12 weeks after epidural steroid injection | incidence of adverse event during 12 weeks after epidural steroid injection |
| pain relief | 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 |
| disability improvement | 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 |
Countries
South Korea
Outcome results
None listed