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    Is low-dose amitriptyline effective in the management of chronic low back pain? Study protocol for a randomised controlled trial

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    Author
    Urquhart, DM; Wluka, A; Sim, MR; van Tulder, M; Forbes, A; Gibson, SJ; Arnold, C; Fong, C; Anthony, SN; Cicuttini, FM
    Date
    2016-10-22
    Source Title
    Trials
    Publisher
    BMC
    University of Melbourne Author/s
    Gibson, Stephen
    Affiliation
    Medicine and Radiology
    Metadata
    Show full item record
    Document Type
    Journal Article
    Citations
    Urquhart, D. M., Wluka, A., Sim, M. R., van Tulder, M., Forbes, A., Gibson, S. J., Arnold, C., Fong, C., Anthony, S. N. & Cicuttini, F. M. (2016). Is low-dose amitriptyline effective in the management of chronic low back pain? Study protocol for a randomised controlled trial. TRIALS, 17 (1), https://doi.org/10.1186/s13063-016-1637-1.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/260572
    DOI
    10.1186/s13063-016-1637-1
    Abstract
    BACKGROUND: Low back pain is a major clinical and public health problem, with limited evidence-based treatments. Low-dose antidepressants are commonly used to treat pain in chronic low back pain. However, their efficacy is unproven. The aim of this pragmatic, double-blind, randomised, placebo-controlled trial is to determine whether low-dose amitriptyline (an antidepressant) is more effective than placebo in reducing pain in individuals with chronic low back pain. METHODS/DESIGN: One hundred and fifty individuals with chronic low back pain will be recruited through hospital and private medical and allied health clinics, advertising in local media and posting of flyers in community locations. They will be randomly allocated to receive either low-dose amitriptyline (25 mg) or an active placebo (benztropine mesylate, 1 mg) for 6 months. The primary outcome measure of pain intensity will be assessed at baseline, 3 and 6 months using validated questionnaires. Secondary measures of self-reported low back disability, work absence and hindrance in the performance of paid/unpaid work will also be examined. Intention-to-treat analyses will be performed. DISCUSSION: This pragmatic, double-blind, randomised, placebo-controlled trial will provide evidence regarding the effectiveness of low-dose antidepressants compared with placebo in reducing pain, disability, work absenteeism and hindrance in work performance in individuals with chronic low back pain. This trial has major public health and clinical importance as it has the potential to provide an effective approach to the management of chronic low back pain. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12612000131853 ; registered on 30 January 2012.

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