title: Is low-dose amitriptyline effective in the management of chronic low back pain? Study protocol for a randomised controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Australian New Zealand Clinical Trials Registry: ACTRN12612000131853 ; registered on 30 January 2012.
authors: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia. Donna.Urquhart@monash.edu.
authors: Donna M
authors: DM
authors: Urquhart
authors: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia.
authors: Anita E
authors: AE
authors: Wluka
authors: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia.
authors: Malcolm R
authors: MR
authors: Sim
authors: Department of Health Sciences and EMGO+, Institute for Health and Care Research, VU University, 1081 HV, Amsterdam, The Netherlands.
authors: Maurits
authors: M
authors: van Tulder
authors: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia.
authors: Andrew
authors: A
authors: Forbes
authors: National Ageing Research Institute, Parkville, Melbourne, 3052, VIC, Australia.|Caulfield Pain Management and Research Centre, Caulfield, Melbourne, 3162, VIC, Australia.
authors: Stephen J
authors: SJ
authors: Gibson
authors: Caulfield Pain Management and Research Centre, Caulfield, Melbourne, 3162, VIC, Australia.|Department of Anaesthesia and Perioperative Medicine, Monash University, Alfred Hospital, Melbourne, 3004, VIC, Australia.
authors: Carolyn
authors: C
authors: Arnold
authors: Eastern Health Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Box Hill, Melbourne, 3128, VIC, Australia.
authors: Chris
authors: C
authors: Fong
authors: Department of Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, 3800, VIC, Australia.
authors: Shane N
authors: SN
authors: Anthony
authors: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia.
authors: Flavia M
authors: FM
authors: Cicuttini
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000639:Amitriptyline / Q000627:therapeutic use*; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use*; D059350:Chronic Pain / Q000188:drug therapy*; D002985:Clinical Protocols; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D018401:Sample Size; D055815:Young Adult
chemical_list: D000929:Antidepressive Agents, Tricyclic; D000639:Amitriptyline
keywords: Amitriptyline; Antidepressants; Low back pain; Pain; Randomised controlled trial