Is antibiotic treatment effective in the management of chronic low back pain with disc herniation?: Study protocol for a randomised controlled trial

Donna M. Urquhart; Jeffrey V. Rosenfeld; Maurits van Tulder; Anita E. Wluka; Karin Leder; Allen C. Cheng; Andrew B. Forbes; Patrick Chan; Richard O’Sullivan; Susan Liew; Flavia M. Cicuttini

doi:10.1186/s13063-021-05728-1

Is antibiotic treatment effective in the management of chronic low back pain with disc herniation? Study protocol for a randomised controlled trial

Donna M. Urquhart^*, Jeffrey V. Rosenfeld, Maurits van Tulder, Anita E. Wluka, Karin Leder, Allen C. Cheng, Andrew B. Forbes, Patrick Chan, Richard O’Sullivan, Susan Liew, Flavia M. Cicuttini

^*Corresponding author for this work

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

BACKGROUND: There 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.

METHODS: One 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.

DISCUSSION: There 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 REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000958583 . Registered on 11 September 2015.

Original language	English
Article number	759
Pages (from-to)	1-10
Number of pages	10
Journal	Trials
Volume	22
Early online date	30 Oct 2021
DOIs	https://doi.org/10.1186/s13063-021-05728-1
Publication status	Published - Dec 2021

Bibliographical note

Funding Information:
This study is supported by the National Health and Medical Research Council of Australia (NHMRC; 1080774). DMU, AEW and KL are recipients of an NHMRC Career Development Fellowship (Clinical Level 2; 1142809), RACP Fellows Career Development Fellowship (Royal Australian College of Physicians) and NHMRC Senior Research Fellowship (1155005) respectively. These funders will have no role in designing the study, data collection and analysis, decision to publish or preparation of the manuscript.

Publisher Copyright:
© 2021, The Author(s).

Funding

This study is supported by the National Health and Medical Research Council of Australia (NHMRC; 1080774). DMU, AEW and KL are recipients of an NHMRC Career Development Fellowship (Clinical Level 2; 1142809), RACP Fellows Career Development Fellowship (Royal Australian College of Physicians) and NHMRC Senior Research Fellowship (1155005) respectively. These funders will have no role in designing the study, data collection and analysis, decision to publish or preparation of the manuscript.

Funders	Funder number
National Health and Medical Research Council	1142809, 1080774
National Health and Medical Research Council
Royal Australasian College of Physicians	1155005
Royal Australasian College of Physicians

Keywords

Antibiotics
Disc herniation
Low back pain
Modic change
Randomised controlled trial

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

Urquhart, D. M., Rosenfeld, J. V., van Tulder, M., Wluka, A. E., Leder, K., Cheng, A. C., Forbes, A. B., Chan, P., O’Sullivan, R., Liew, S., & Cicuttini, F. M. (2021). Is antibiotic treatment effective in the management of chronic low back pain with disc herniation? Study protocol for a randomised controlled trial. Trials, 22, 1-10. Article 759. https://doi.org/10.1186/s13063-021-05728-1

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title = "Is antibiotic treatment effective in the management of chronic low back pain with disc herniation?: Study protocol for a randomised controlled trial",

abstract = "BACKGROUND: There 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.METHODS: One 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.DISCUSSION: There 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 REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000958583 . Registered on 11 September 2015.",

keywords = "Antibiotics, Disc herniation, Low back pain, Modic change, Randomised controlled trial",

author = "Urquhart, {Donna M.} and Rosenfeld, {Jeffrey V.} and {van Tulder}, Maurits and Wluka, {Anita E.} and Karin Leder and Cheng, {Allen C.} and Forbes, {Andrew B.} and Patrick Chan and Richard O{\textquoteright}Sullivan and Susan Liew and Cicuttini, {Flavia M.}",

note = "Funding Information: This study is supported by the National Health and Medical Research Council of Australia (NHMRC; 1080774). DMU, AEW and KL are recipients of an NHMRC Career Development Fellowship (Clinical Level 2; 1142809), RACP Fellows Career Development Fellowship (Royal Australian College of Physicians) and NHMRC Senior Research Fellowship (1155005) respectively. These funders will have no role in designing the study, data collection and analysis, decision to publish or preparation of the manuscript. Publisher Copyright: {\textcopyright} 2021, The Author(s).",

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doi = "10.1186/s13063-021-05728-1",

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T1 - Is antibiotic treatment effective in the management of chronic low back pain with disc herniation?

T2 - Study protocol for a randomised controlled trial

AU - Urquhart, Donna M.

AU - Rosenfeld, Jeffrey V.

AU - van Tulder, Maurits

AU - Wluka, Anita E.

AU - Leder, Karin

AU - Cheng, Allen C.

AU - Forbes, Andrew B.

AU - Chan, Patrick

AU - O’Sullivan, Richard

AU - Liew, Susan

AU - Cicuttini, Flavia M.

N1 - Funding Information: This study is supported by the National Health and Medical Research Council of Australia (NHMRC; 1080774). DMU, AEW and KL are recipients of an NHMRC Career Development Fellowship (Clinical Level 2; 1142809), RACP Fellows Career Development Fellowship (Royal Australian College of Physicians) and NHMRC Senior Research Fellowship (1155005) respectively. These funders will have no role in designing the study, data collection and analysis, decision to publish or preparation of the manuscript. Publisher Copyright: © 2021, The Author(s).

PY - 2021/12

Y1 - 2021/12

N2 - BACKGROUND: There 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.METHODS: One 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.DISCUSSION: There 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 REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000958583 . Registered on 11 September 2015.

AB - BACKGROUND: There 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.METHODS: One 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.DISCUSSION: There 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 REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000958583 . Registered on 11 September 2015.

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KW - Low back pain

KW - Modic change

KW - Randomised controlled trial

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