PRECISE
Trial question
What is the role of pregabalin in patients with acute and chronic sciatica?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
56.0% female
44.0% male
N = 207
207 patients (115 female, 92 male).
Inclusion criteria: outpatients with moderate-to-severe sciatica.
Key exclusion criteria: known or suspected serious pathologic condition of the spine; pregnancy; considering or planning spinal surgery for sciatica during the first 8 weeks of the trial; contraindications to pregabalin.
Interventions
N=106 pregabalin (at a dose of 150 mg/day, adjusted to a maximum dose of 600 mg/day, for up to 8 weeks).
N=101 placebo (matching placebo for up to 8 weeks).
Primary outcome
Leg pain intensity score at week 8
3.7 points
3.1 points
3.7 points
2.8 points
1.9 points
0.9 points
0.0 points
Pregabalin
Placebo
No significant
difference ↔
No significant difference in leg pain intensity score at week 8 (3.7 points vs. 3.1 points; MD 0.5, 95% CI -0.2 to 1.2).
Secondary outcomes
No significant difference in leg pain intensity score at week 52 (3.4 points vs. 3 points; MD 0.3, 95% CI -0.5 to 1).
No significant difference in extent of disability score on the Roland Disability Questionnaire for Sciatica at week 8 (9.1 points vs. 8.5 points; MD 0.1, 95% CI -1.8 to 2).
No significant difference in back pain intensity score at week 8 (3.5 points vs. 3.1 points; MD 0.2, 95% CI -0.6 to 1).
Safety outcomes
No significant difference in serious adverse events and suicidal thoughts.
Significant differences in adverse events (64.2% vs. 42.6%), dizziness (39.6% vs. 12.9%).
Conclusion
In outpatients with moderate-to-severe sciatica, pregabalin was not superior to placebo with respect to leg pain intensity score at week 8.
Reference
Stephanie Mathieson, Christopher G Maher, Andrew J McLachlan et al. Trial of Pregabalin for Acute and Chronic Sciatica. N Engl J Med. 2017 Mar 23;376(12):1111-1120.
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