Is amitriptyline effective in the management of chronic low back pain?

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Chronic low back pain is a major public health problem. Antidepressants are one commonly prescribed treatment for low back pain, and are used not only to treat depression and insomnia, but chronic pain. Their use is rapidly increasing, despite lack of supportive evidence and conflicting recommendations from clinical guidelines. Aims: In community-based adults with chronic low back pain, we aim to determine: 1. If low dose amitriptyline (tricyclic antidepressant) is more effective than an active placebo in the management of pain 2. If low dose amitriptyline is more effective than an active placebo in improving disability and reducing work absence and hindrance. Methods: A double-blind, randomized, placebo-controlled trial will be conducted. We will recruit 150 subjects with chronic low back pain. Participants will receive low-dose amitriptyline or an active placebo for 6 months. Pain, disability and work absence and hindrance will be assessed at baseline, 3 and 6 months using valid measures. Implications: If antidepressants are found to be effective, it will provide high quality evidence for their use, potentially enabling this treatment option to be considered by more individuals with chronic low back pain. If we do not find antidepressants to be effective, then this trial will provide strong evidence to review international guidelines that recommend their use and to evaluate the extensive use of tricyclic antidepressants for chronic low back pain.