Phase 3
N=82
A Trial of Corticosteroids for Low Back Pain
Radicular Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT00290589 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable — 7.1; 5.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intramuscular methylprednisolone acetate (Drug); Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable |
7.1; 5.8 | — |
| PRIMARY Functional Disability Scales |
0; 0 | — |
| SECONDARY Number of Patients Using Analgesics |
8; 17 | — |
Summary
Low back pain is a common symptom that functionally disables many people. When the low back pain is accompanied by pain that shoots down the leg, it is felt to be caused by a herniated disc. We are conducting this study to determine if a powerful anti-inflammatory agent will decrease the pain and functional impairment that is associated with this illness.
Eligibility Criteria
Inclusion Criteria
- 21-50 years old, non-traumatic low back pain for one week or less,
Exclusion Criteria
- fever, pregnancy, lactation, allergy or intolerance to study medication, suspected active oncologic, urologic, or gynecologic disease
Data sourced from ClinicalTrials.gov (NCT00290589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.