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...
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| Format: | Article |
| Language: | English |
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BMC
2021-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05728-1 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Donna M. Urquhart |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-22T05:28:59Z |
| format | Article |
| id | doaj.art-4505aca2b1a44864ba5d1d01d47cf31d |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-22T05:28:59Z |
| publishDate | 2021-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4505aca2b1a44864ba5d1d01d47cf31d2022-12-21T18:37:30ZengBMCTrials1745-62152021-10-0122111010.1186/s13063-021-05728-1Is antibiotic treatment effective in the management of chronic low back pain with disc herniation? Study protocol for a randomised controlled trialDonna M. Urquhart0Jeffrey V. Rosenfeld1Maurits van Tulder2Anita E. Wluka3Karin Leder4Allen C. Cheng5Andrew B. Forbes6Patrick Chan7Richard O’Sullivan8Susan Liew9Flavia M. Cicuttini10Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred HospitalDepartment of Neurosurgery, Alfred HospitalDepartment of Human Movement Sciences, Faculty Behavioural and Movement Sciences, Vrije Universiteit AmsterdamDepartment of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred HospitalDepartment of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred HospitalDepartment of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred HospitalDepartment of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred HospitalDepartment of Neurosurgery, Alfred HospitalMRI Department, Healthcare Imaging Services, Epworth HospitalDepartment of Orthopaedic Surgery, Alfred HospitalDepartment of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred HospitalAbstract 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 2015https://doi.org/10.1186/s13063-021-05728-1AntibioticsLow back painDisc herniationModic changeRandomised controlled trial |
| spellingShingle | 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 Is antibiotic treatment effective in the management of chronic low back pain with disc herniation? Study protocol for a randomised controlled trial Trials Antibiotics Low back pain Disc herniation Modic change Randomised controlled trial |
| title | Is antibiotic treatment effective in the management of chronic low back pain with disc herniation? Study protocol for a randomised controlled trial |
| title_full | Is antibiotic treatment effective in the management of chronic low back pain with disc herniation? Study protocol for a randomised controlled trial |
| title_fullStr | Is antibiotic treatment effective in the management of chronic low back pain with disc herniation? Study protocol for a randomised controlled trial |
| title_full_unstemmed | Is antibiotic treatment effective in the management of chronic low back pain with disc herniation? Study protocol for a randomised controlled trial |
| title_short | Is antibiotic treatment effective in the management of chronic low back pain with disc herniation? Study protocol for a randomised controlled trial |
| title_sort | is antibiotic treatment effective in the management of chronic low back pain with disc herniation study protocol for a randomised controlled trial |
| topic | Antibiotics Low back pain Disc herniation Modic change Randomised controlled trial |
| url | https://doi.org/10.1186/s13063-021-05728-1 |
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