Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study

Torsten Gordh, Audun Stubhaug, Troels Jensen, Staffan Arner, Björn Biber, Jörgen Boivie, Clas Mannheimer, Jarkko Kalliomäki, Eija Kalso

    Research output: Contribution to journalArticleScientificpeer-review

    Abstract

    A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses tip to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p = 0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p = 0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p = 0.0016). Both the Patient (p = 0.023) and Clinician (p = 0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness. (C) 2007 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
    Original languageEnglish
    JournalPain
    Volume138
    Issue number2
    Pages (from-to)255-266
    Number of pages12
    ISSN0304-3959
    DOIs
    Publication statusPublished - 2008
    MoE publication typeA1 Journal article-refereed

    Cite this

    Gordh, Torsten ; Stubhaug, Audun ; Jensen, Troels ; Arner, Staffan ; Biber, Björn ; Boivie, Jörgen ; Mannheimer, Clas ; Kalliomäki, Jarkko ; Kalso, Eija. / Gabapentin in traumatic nerve injury pain : a randomized, double-blind, placebo-controlled, cross-over, multi-center study. In: Pain. 2008 ; Vol. 138, No. 2. pp. 255-266.
    @article{facafc7c65c442fe9ef4f1b3f8e62bc4,
    title = "Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study",
    abstract = "A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses tip to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p = 0.015) compared with placebo. More patients had at least a 30{\%} pain reduction with gabapentin compared with placebo (p = 0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p = 0.0016). Both the Patient (p = 0.023) and Clinician (p = 0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness. (C) 2007 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.",
    author = "Torsten Gordh and Audun Stubhaug and Troels Jensen and Staffan Arner and Bj{\"o}rn Biber and J{\"o}rgen Boivie and Clas Mannheimer and Jarkko Kalliom{\"a}ki and Eija Kalso",
    year = "2008",
    doi = "10.1016/j.pain.2007.12.011",
    language = "English",
    volume = "138",
    pages = "255--266",
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    Gordh, T, Stubhaug, A, Jensen, T, Arner, S, Biber, B, Boivie, J, Mannheimer, C, Kalliomäki, J & Kalso, E 2008, 'Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study', Pain, vol. 138, no. 2, pp. 255-266. https://doi.org/10.1016/j.pain.2007.12.011

    Gabapentin in traumatic nerve injury pain : a randomized, double-blind, placebo-controlled, cross-over, multi-center study. / Gordh, Torsten; Stubhaug, Audun; Jensen, Troels; Arner, Staffan; Biber, Björn; Boivie, Jörgen; Mannheimer, Clas; Kalliomäki, Jarkko; Kalso, Eija.

    In: Pain, Vol. 138, No. 2, 2008, p. 255-266.

    Research output: Contribution to journalArticleScientificpeer-review

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    AU - Stubhaug, Audun

    AU - Jensen, Troels

    AU - Arner, Staffan

    AU - Biber, Björn

    AU - Boivie, Jörgen

    AU - Mannheimer, Clas

    AU - Kalliomäki, Jarkko

    AU - Kalso, Eija

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    N2 - A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses tip to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p = 0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p = 0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p = 0.0016). Both the Patient (p = 0.023) and Clinician (p = 0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness. (C) 2007 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

    AB - A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses tip to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p = 0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p = 0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p = 0.0016). Both the Patient (p = 0.023) and Clinician (p = 0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness. (C) 2007 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

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