N/A
N=145
Steroids Versus Gabapentin
Sciatica · Radiculopathy
Bottom Line
View on ClinicalTrials.gov: NCT01495923 ↗Enrolled (actual)
145
Serious AEs
23.5%
Results posted
Apr 2017
Primary outcome: Primary: Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale — 3.3; 3.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- epidural steroid injection (Procedure); Sham epidural steroid injection (Procedure); Gabapentin (Drug); Placebo gabapentin (Drug)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale |
3.3; 3.7 | — |
| PRIMARY Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale |
3.7; 3.4 | — |
| PRIMARY Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale |
4.9; 5.8 | — |
| PRIMARY Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale |
5.2; 5.5 | — |
| SECONDARY Average Back Pain at 1 Month Measured Using the Numeric Pain Scale |
3.5; 3.6 | — |
| SECONDARY Average Back Pain at 3 Months Measured Using the Numeric Pain Scale |
3.9; 3.7 | — |
| SECONDARY Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index |
32.6; 29.6 | — |
| SECONDARY Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index |
33.6; 29.6 | — |
| SECONDARY Global Perceived Effect of Treatment at 3 Months After the Start of Treatment |
27; 21; 46; 51 | — |
| SECONDARY Global Perceived Effect of Treatment at 1 Month After the Start of Treatment |
48; 33; 25; 39 | — |
| SECONDARY Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale |
5.1; 5.4 | — |
| SECONDARY Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale |
5.6; 5.6 | — |
| SECONDARY Proceeded to Surgery Within Year of Enrollment |
9; 10 | — |
Summary
The purpose of this study is to determine whether pharmacotherapy or epidural steroid injections are a better treatment for lumbosacral radicular pain.
142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will be allocated to receive an epidural steroid injection (ESI; group I), with an equal number allocated to receive gabapentin (group II). Patients & evaluating physicians will be blinded. Follow-up will be through 3-months after treatment.
Eligibility Criteria
Inclusion Criteria
- Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
- Numerical Rating Scale leg pain score > 4 (or if 3/10, greater or equal to back pain)
- MRI evidence of spinal pathology consistent with symptoms
Exclusion Criteria
- Untreated coagulopathy
- Previous spine surgery
- No MRI study
- Leg pain > 4 years duration Epidural steroid injection within past 3 years Cauda equina syndrome Previous failed trials with gabapentin or pregabalin Allergic reactions to gabapentin or pregabalin Referrals from surgery for diagnostic injections for surgical evaluation Serious medical or psychiatric that condition that might preclude optimal outcome or interfere with participation, such as the need for uninterrupted anticoagulation.
Pregnancy
Data sourced from ClinicalTrials.gov (NCT01495923). 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.