Trial of pregabalin for acute and chronic sciatica
Open accessAbstract
BACKGROUND: Sciatica can be disabling, and evidence regarding medical treatments is limited. Pregabalin is effective in the treatment of some types of neuropathic pain. This study examined whether pregabalin may reduce the intensity of sciatica. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of pregabalin in patients with sciatica. Patients were randomly assigned to receive either pregabalin at a dose of 150 mg per day that was adjusted to a maximum dose of 600 mg per day or matching placebo for up to 8 weeks. The primary outcome was the leg-pain intensity score on a 10-point scale (with 0 indicating no pain and 10 the worst possible pain) at week 8; the leg-pain intensity score was also evaluated at week 52, a secondary time point for the primary outcome. Secondary outcomes included the extent of disability, back-pain intensity, and quality-of-life measures at prespecified time points over the course of 1 year. RESULTS: A total of 209 patients underwent randomization, of whom 108 received pregabalin and 101 received placebo; after randomization, 2 patients in the pregabalin group were determined to be ineligible and were excluded from the analyses. At week 8, the mean unadjusted leg-pain intensity score was 3.7 in the pregabalin group and 3.1 in the placebo group (adjusted mean difference, 0.5; 95% confidence interval [CI], -0.2 to 1.2; P=0.19). At week 52, the mean unadjusted leg-pain intensity score was 3.4 in the pregabalin group and 3.0 in the placebo group (adjusted mean difference, 0.3; 95% CI, -0.5 to 1.0; P=0.46). No significant between-group differences were observed with respect to any secondary outcome at either week 8 or week 52. A total of 227 adverse events were reported in the pregabalin group and 124 in the placebo group. Dizziness was more common in the pregabalin group than in the placebo group. CONCLUSIONS: Treatment with pregabalin did not significantly reduce the intensity of leg pain associated with sciatica and did not significantly improve other outcomes, as compared with placebo, over the course of 8 weeks. The incidence of adverse events was significantly higher in the pregabalin group than in the placebo group. (Funded by the National Health and Medical Research Council of Australia; PRECISE Australian and New Zealand Clinical Trials Registry number, ACTRN12613000530729 .).
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In one pregabalin trial, quality of life measured by SF-12 showed no statistical differences at 2, 8, 26, and 52 weeks.
“Quality of life (QoL) through the SF-12 questionnaire was assessed in one of the pregabalin trials.21 No statistical differences were found at 2, 8, 26 and 52 weeks.”
From A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain (2022) · cites this paper as [21]
The Outcomes and Data Collection section identifies the SF-12 as the trial’s quality-of-life measure. The Efficacy section reports no statistically significant differences in its physical or mental components at weeks 8 and 52, but our copy does not report quality-of-life significance results at weeks 2 or 26. (LLM, conf=0.87)
Experimental — accuracy not yet measuredSerious adverse events were similar in the pregabalin group and the placebo group.
“Serious AE were similar in the pregabalin group and the placebo group21, 27 as well as in patients with one or more AE.27, 28”
From A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain (2022) · cites this paper as [21]
Evidence on the use of gabapentin and pregabalin for pain associated with acute sciatica is limited.
“This study focuses specifically on the use of gabapentin and pregabalin for pain associated with acute sciatica since the evidence on their use is limited.”
From A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain (2022) · cites this paper as [21]
Other potential sources of bias gave a low risk for four studies, unclear for three, and high for one.
“Assessment of other potential sources of bias gave a low risk of bias for four studies.20, 21, 30, 31 Three were rated as unclear risk of bias28, 29, 32 and one was rated as high risk of bias27 due to a run-in period, where placebo respondents and pregabalin non-respondents were eliminated.”
From A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain (2022) · cites this paper as [21]
Five trials were double-blinded, one was single-blinded, and two were open label.
“Five were double-blinded21, 27, 28, 29, 32; one was single-blinded30; and two were open label.20, 31”
From A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain (2022) · cites this paper as [21]
Three studies compared pregabalin with placebo, and one three-arm trial compared limaprost with pregabalin and with a combination of limaprost and pregabalin.
“In particular as regards pregabalin, three studies compared pregabalin versus placebo21, 27, 29 and one compared limaprost versus pregabalin versus an association of both drugs in a three-arm trial.28”
From A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain (2022) · cites this paper as [21]
Only four studies assessed pregabalin undesirable effects.
“Only four studies assessed pregabalin undesirable effects.21, 27, 28, 29”
From A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain (2022) · cites this paper as [21]
Prior to this review, pain relief with gabapentinoids for sciatica had been reported in only one trial comparing gabapentin with placebo and in no trial investigating pregabalin.
“To our knowledge regarding their use on sciatica, pain relief only has been reported in one trial comparing gabapentin with placebo20 and in no one of those investigating pregabalin.21”
From A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain (2022) · cites this paper as [21]
Attrition bias was rated as unclear for most trials, low for three, and high for two.
“Attrition bias was rated as an unclear risk for most of the trials. Three were rated as low risk of bias,21, 27, 31 and two were rated as high risk of bias.29, 32”
From A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain (2022) · cites this paper as [21]
The citation identifies this pregabalin trial as one of the three rated low risk for attrition bias. The Statistical Analysis section reports less than 10% missing primary-outcome data and intention-to-treat analysis, but our copy does not give the trial an attrition-bias rating. Searches for the quoted rating and for risk-of-bias assessments across trials found no such assessment. (LLM, conf=0.72)
Experimental — accuracy not yet measured
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- Authors
- Mathieson, S., Maher, C. G., McLachlan, A. J., Latimer, J., Koes, B. W., Hancock, M. J., Harris, I., Day, R. O., Billot, L., Pik, J., Jan, S., & Lin, C.-W. C.
- Affiliations
- The University of Sydney (AU)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-03-23
- Volume
- 376
- Issue
- 12
- Pages
- 1111-1120
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2600085695
- Cited by
- 219
- References
- 32
- Citations by year
- 2026: 17 · 2025: 15 · 2024: 22 · 2023: 23 · 2022: 16 · 2021: 19 · 2020: 28 · 2019: 30 · 2018: 32 · 2017: 17
- FWCI
- 20.43
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- The Sydney eScholarship Repository (The University of Sydney) (submittedVersion)
- Funders
- Pfizer
- GlaxoSmithKline
- GlaxoSmithKline Australia
- Medical Research Council
- National Health and Medical Research Council (1042073)
- Topics
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Physiology › Pain Mechanisms and Treatments
- Health Sciences › Medicine › Pathology and Forensic Medicine › Spine and Intervertebral Disc Pathology
- Keywords
- sciatica, pregabalin, leg pain, neuropathic pain, pain intensity, disability, back pain, quality of life, adverse events, dizziness, drug efficacy, placebo comparison, chronic sciatica, acute sciatica, lumbar radiculopathy, drug safety, dose adjustment, adverse drug reactions
- MeSH terms
- Pregabalin, Adult, Aged, Analgesics, Back Pain, Disability Evaluation, Dizziness, Double-Blind Method, Female, Humans, Male, Middle Aged, Pain Measurement, Quality of Life, Sciatica, Treatment Failure
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