Evidence map›Paper›PMID 25503625›Full record

Trial reportNeurology2015

Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication.

John D Markman, Maria E Frazer, Shirley A Rast, Michael P McDermott, Jennifer S Gewandter, Amit K Chowdhry, Kate Czerniecka, Webster H Pilcher, Lee S Simon, Robert H Dworkin

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 8 pooled it
4.0field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 8 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
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  6. Danish national clinical guidelines for surgical and nonsurgical treatment of patients with lumbar spinal stenosis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2019
    Guideline
  7. Anticonvulsants in the treatment of low back pain and lumbar radicular pain: a systematic review and meta-analysis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2018
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

John D MarkmanFrom the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., S.A.R., K.C., W.H.P.), and Departments of Biostatistics and Computational Biology (M.P.M., A.K.C.), Neurology (M.P.M., A.K.C.), and Anesthesiology (J.S.G., R.H.D.), University of Rochester School of Medicine and Dentistry, Rochester, NY; and SDG LLC (L.S.S.), Cambridge, MA. john_markman@urmc.rochester.edu.
Maria E FrazerFrom the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., S.A.R., K.C., W.H.P.), and Departments of Biostatistics and Computational Biology (M.P.M., A.K.C.), Neurology (M.P.M., A.K.C.), and Anesthesiology (J.S.G., R.H.D.), University of Rochester School of Medicine and Dentistry, Rochester, NY; and SDG LLC (L.S.S.), Cambridge, MA.
Shirley A RastFrom the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., S.A.R., K.C., W.H.P.), and Departments of Biostatistics and Computational Biology (M.P.M., A.K.C.), Neurology (M.P.M., A.K.C.), and Anesthesiology (J.S.G., R.H.D.), University of Rochester School of Medicine and Dentistry, Rochester, NY; and SDG LLC (L.S.S.), Cambridge, MA.
Michael P McDermottFrom the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., S.A.R., K.C., W.H.P.), and Departments of Biostatistics and Computational Biology (M.P.M., A.K.C.), Neurology (M.P.M., A.K.C.), and Anesthesiology (J.S.G., R.H.D.), University of Rochester School of Medicine and Dentistry, Rochester, NY; and SDG LLC (L.S.S.), Cambridge, MA.
Jennifer S GewandterFrom the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., S.A.R., K.C., W.H.P.), and Departments of Biostatistics and Computational Biology (M.P.M., A.K.C.), Neurology (M.P.M., A.K.C.), and Anesthesiology (J.S.G., R.H.D.), University of Rochester School of Medicine and Dentistry, Rochester, NY; and SDG LLC (L.S.S.), Cambridge, MA.
Amit K ChowdhryFrom the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., S.A.R., K.C., W.H.P.), and Departments of Biostatistics and Computational Biology (M.P.M., A.K.C.), Neurology (M.P.M., A.K.C.), and Anesthesiology (J.S.G., R.H.D.), University of Rochester School of Medicine and Dentistry, Rochester, NY; and SDG LLC (L.S.S.), Cambridge, MA.
Kate CzernieckaFrom the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., S.A.R., K.C., W.H.P.), and Departments of Biostatistics and Computational Biology (M.P.M., A.K.C.), Neurology (M.P.M., A.K.C.), and Anesthesiology (J.S.G., R.H.D.), University of Rochester School of Medicine and Dentistry, Rochester, NY; and SDG LLC (L.S.S.), Cambridge, MA.
Webster H PilcherFrom the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., S.A.R., K.C., W.H.P.), and Departments of Biostatistics and Computational Biology (M.P.M., A.K.C.), Neurology (M.P.M., A.K.C.), and Anesthesiology (J.S.G., R.H.D.), University of Rochester School of Medicine and Dentistry, Rochester, NY; and SDG LLC (L.S.S.), Cambridge, MA.
Lee S SimonFrom the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., S.A.R., K.C., W.H.P.), and Departments of Biostatistics and Computational Biology (M.P.M., A.K.C.), Neurology (M.P.M., A.K.C.), and Anesthesiology (J.S.G., R.H.D.), University of Rochester School of Medicine and Dentistry, Rochester, NY; and SDG LLC (L.S.S.), Cambridge, MA.
Robert H DworkinFrom the Department of Neurosurgery, Translational Pain Research Program (J.D.M., M.E.F., S.A.R., K.C., W.H.P.), and Departments of Biostatistics and Computational Biology (M.P.M., A.K.C.), Neurology (M.P.M., A.K.C.), and Anesthesiology (J.S.G., R.H.D.), University of Rochester School of Medicine and Dentistry, Rochester, NY; and SDG LLC (L.S.S.), Cambridge, MA.
Strategic Science & Technologies (United States) · US

Funding

The University of Rochester's Clinical and Translational Science InstituteUL1TR000042 · NCATS · UNIVERSITY OF ROCHESTER · PI BENNETT, NANCY M, KIEBURTZ, KARL D. · 2012 to 2015
$14.4M
NCATS NIH HHS UL1 TR000042
6 · The paper itself

Abstract

objectivesTo test the effects of pregabalin on the induction of neurogenic claudication.

methodsThis study was a randomized, double-blind, active placebo-controlled, 2-period, crossover trial. Twenty-nine subjects were randomized to receive pregabalin followed by active placebo (i.e., diphenhydramine) or active placebo followed by pregabalin. Each treatment period lasted 10 days, including a 2-step titration. Periods were separated by a 10-day washout period, including a 3-day taper phase after the first period. The primary outcome variable was the time to first moderate pain symptom (Numeric Rating Scale score ≥4) during a 15-minute treadmill test (Tfirst). Secondary outcome measures included pain intensity at rest, pain intensity at the end of the treadmill test, distance walked, and validated self-report measures of pain and functional limitation including the Roland-Morris Disability Questionnaire, modified Brief Pain Inventory-Short Form, Oswestry Disability Index, and Swiss Spinal Stenosis Questionnaire.

resultsNo significant difference was found between pregabalin and active placebo for the time to first moderate pain symptom (difference in median Tfirst = -1.08 [95% confidence interval -2.25 to 0.08], p = 0.61). In addition, none of the secondary outcome measures of pain or functional limitation were significantly improved by pregabalin compared with active placebo.

conclusionsPregabalin was not more effective than active placebo in reducing painful symptoms or functional limitations in patients with neurogenic claudication associated with lumbar spinal stenosis. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with neurogenic claudication, compared with diphenhydramine, pregabalin does not increase the time to moderate pain during a treadmill test.

Indexed as

AgedAnalgesicsCross-Over StudiesDisability EvaluationDose-Response Relationship, DrugDouble-Blind MethodExercise TestFemalegamma-Aminobutyric AcidHumansLumbar VertebraeMaleMiddle AgedOutcome Assessment, Health CarePainPain MeasurementAnalgesicsgamma-Aminobutyric AcidPregabalin

Identifiers

PMID25503625
PMCPMC4335998
OpenAlexW2122401423

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.