Trial of Pregabalin for Acute and Chronic Sciatica.
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.



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.



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.



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 .).
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
Stephanie
S
Mathieson
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
Christopher G
CG
Maher
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
Andrew J
AJ
McLachlan
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
Jane
J
Latimer
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
Bart W
BW
Koes
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
Mark J
MJ
Hancock
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
Ian
I
Harris
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
Richard O
RO
Day
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
Laurent
L
Billot
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
Justin
J
Pik
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
Stephen
S
Jan
From the George Institute for Global Health and Sydney Medical School (S.M., C.G.M., J.L., L.B., S.J., C.-W.C.L.) and Faculty of Pharmacy and Centre for Education and Research on Ageing (A.J.M.), University of Sydney, Faculty of Medicine and Health Science, Macquarie University (M.J.H.), the Ingham Institute for Applied Medical Research, South Western Sydney Clinical School (I.H.), and St. Vincent's Clinical School (R.O.D.), Faculty of Medicine, University of New South Wales, Sydney, and Australian Capital Territory NeuroSpine Clinic, Deakin, ACT (J.P.) - all in Australia; and the Department of General Practice, Erasmus University Medical Center, Rotterdam, the Netherlands (B.W.K.).
C-W Christine
CC
Lin
D000328:Adult; D000368:Aged; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001416:Back Pain / Q000145:classification; D004185:Disability Evaluation; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D000069583:Pregabalin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012585:Sciatica / Q000145:classification / Q000188:drug therapy*; D017211:Treatment Failure
D000700:Analgesics; D000069583:Pregabalin