Abstract
BackgroundThere has been immense interest and debate regarding the effectiveness of antibiotic treatment for chronic low back pain. Two randomised controlled trials have examined the efficacy of antibiotics for chronic low back pain with disc herniation and Modic changes, but have reported conflicting results. The aim of this double-blind, randomised, placebo-controlled trial is to determine the efficacy of antibiotic treatment in a broader patient subgroup of chronic low back pain with disc herniation and investigate whether the presence of Modic changes predicts response to antibiotic therapy.MethodsOne hundred and seventy individuals with chronic low back pain will be recruited through hospital and private medical and allied health clinics; advertising in national, community and social media; and posting of flyers in community locations. They will be randomly allocated to receive either amoxicillin-clavulanate (500 mg/125 mg) twice per day for 90 days or placebo. The primary outcome measure of pain intensity will be assessed using the Low Back Pain Rating scale and a 100-mm visual analogue scale at 12 months. Secondary measures of self-reported low back disability and work absence and hindrance will also be examined, and an economic analysis will be conducted. Intention-to-treat analyses will be performed.DiscussionThere is uncertainty about whether antibiotic treatment is effective for chronic low back pain and, if effective, which patient subgroup is most likely to respond. We will conduct a clinical trial to investigate the efficacy of antibiotics compared with placebo in individuals with chronic low back pain and a disc herniation. Our findings will provide high-quality evidence to assist in answering these questions.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12615000958583. Registered on 11 September 2015
Highlights
There has been immense interest and debate regarding the effectiveness of antibiotic treatment for chronic low back pain
While there is evidence for a role of bacteria in chronic low back pain, it remains unclear whether antibiotic treatment is effective for chronic low back pain and whether disc herniation with Modic changes represents a select target population, or whether all individuals with disc herniation may respond to antibiotics
We present the protocol for a double-blind, randomised, placebo-controlled trial investigating whether antibiotic treatment is effective in the management of chronic low back pain with disc herniation and if the presence of Modic changes predicts those individuals more likely to respond to antibiotic therapy
Summary
Study design This study is a double-blind, randomised, placebocontrolled trial, with a two-arm, parallel group, superiority design. Outcome measures The following primary and secondary self-report outcome measures will be provided by blinded research assistants at baseline and 3, 6, 9 and 12 months in the form of printed questionnaires sent by postal mail and/. Data collection for economic evaluation Cost data will be measured using cost questionnaires completed by participants at baseline and 3, 6, 9 and 12 months of follow-up. The cost questionnaires will include information on all health care utilisation due to chronic low back pain, such as the number and type of medical and allied health visits, imaging usage, amount and type of medication (using The Medication Quantification Scale [22]), other care/assistance (i.e. home-care assistance) and hours of absenteeism from paid and unpaid work. The trial will be formally stopped if metformin is found to have unacceptable side effects
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