Abstract
BackgroundLow 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/designOne 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trials Registry: ACTRN12612000131853; registered on 30 January 2012.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1637-1) contains supplementary material, which is available to authorized users.
Highlights
Low back pain is a major clinical and public health problem, with limited evidence-based treatments
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
Summary
Low back pain is a major clinical and public health problem, with limited evidence-based treatments. Low back pain is a major public health problem worldwide It is one of the most widespread health conditions, with a lifetime prevalence of more than 70 % in industrialised countries [1]. There is evidence to indicate that TCAs and SSRIs have an effect on the endogenous opioid system and can act peripherally [7] These mechanisms are thought to be important in targeting central sensitisation in chronic low back pain, where an abnormal state of responsiveness or increased gain in the nociceptive system occurs and neurons activated by nociceptive stimulus are sensitised and become hyperresponsive to subsequent stimuli [8]. The analgesic effect of low-dose antidepressants has been shown to be independent of their mood-altering effect [10]
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