Study protocol

Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617]

Mark J Hancock¹ , Christopher G Maher¹ , Jane Latimer¹ , Andrew J McLachlan² , Chris W Cooper³ , Richard O Day⁴ , Megan F Spindler¹ and James H McAuley¹

¹Back Pain Research Group, University of Sydney, PO Box 170, Lidcombe, NSW, 1825, Australia

²Faculty of Pharmacy, University of Sydney, NSW, 2006, Australia

³Discipline of General Practice, Balmain Hospital, 37A Booth St, Balmain, 2041, NSW, Australia

⁴Clinical Pharmacology, UNSW & St Vincent's Hospital, Darlinghurst 2010, NSW, Australia

author email corresponding author email

BMC Musculoskeletal Disorders 2005, 6:57doi:10.1186/1471-2474-6-57

Published:	10 November 2005

Abstract

Background

Acute low back pain is a common condition resulting in pain and disability. Current national and international guidelines advocate general practitioner care including advice and paracetamol (4 g daily in otherwise well adults) as the first line of care for people with acute low back pain. Non-steroidal anti-inflammatory drugs (NSAIDs) and spinal manipulative therapy (SMT) are advocated in many guidelines as second line management options for patients with acute low back pain who are not recovering. No studies have explored the role of NSAIDs and/or SMT in addition to first line management for acute low back pain. The primary aim of this study is to investigate if NSAIDs and/or SMT in addition to general practitioner advice and paracetamol results in shorter recovery times for patients with acute low back pain. The secondary aims of the study are to evaluate whether the addition of SMT and/or NSAIDs influences pain, disability and global perceived effect at 1, 2, 4 and 12 weeks after onset of therapy for patients with significant acute low back pain.

Methods/design

This paper presents the rationale and design of a randomised controlled trial examining the addition of NSAIDs and/or SMT in 240 people who present to their general practitioner with significant acute low back pain.