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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515824-35-01 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Erasmus University Rotterdam | OTHER |
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The goal of this clinical trial is to learn if antibiotics (amoxicillin) work to treat chronic low back pain in adults. In some patients, this type of back pain may be caused by bacteria in the vertebrae, resulting in a condition known as "Modic type I change."
The main questions the trial aims to answer are:
Researchers will compare amoxicillin to a placebo (a look-alike substance that contains no active drug) to see if amoxicillin works to treat chronic low back pain.
Participants in the trial will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic treatment (amoxicillin) | Experimental | A dose of 1000 mg (3 times a day) for a period of 100 days |
|
| Placebo | Placebo Comparator | A dose of 1000 mg (3 times a day) for a period of 100 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | Antibiotic treatment (amoxicillin) with a dosage of 1000 mg (3 times a day) for a period of 100 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Roland Morris Disability Questionnaire (RMDQ) | The primary outcome is pain and disability measured with the Roland Morris Disability Questionnaire (RMDQ). The scale ranges from 0-24 in which a higher score indicates higher disability. The RMDQ was also the primary outcome in the previous trials, and it is a recommended core outcome measure for trials in LBP. | The measurements are scheduled at baseline and at 3, 6 and 12 months follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| LBP-intensity (0-10 NRS-scale) | In the form of a questionnaire | Measured at baseline, 3 months, 6 months and 12 months |
| Leg pain intensity (0-10 NRS-scale) | In the form of a questionnaire |
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Inclusion Criteria:
Aged 18-65 years.
Chronic low back pain (i.e. duration >6 months) after a previous (MRI confirmed) disc herniation within the past 6 months to 2 years.
At least 2 of the following questions should be answered with "Yes":
The mean pain intensity should be at least 5 points on a 0-10 NRS-scale, calculated as the mean pain intensity of 3 indices: current pain, worst pain within the preceding two weeks, and the usual mean pain within the preceding two weeks.
Modic Type I changes visible on the MRI-scan in the vertebrae adjacent to the previous herniated disc.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tamana Meihandoest, MSc | Contact | +31627571742 | t.meihandoest@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30496104 | Background | GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. | |
| 35507483 |
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| Placebo | Other | Placebo with a dose of 1000 mg (3 times a day) for a period of 100 days |
|
| Measured at baseline, 3 months, 6 months and 12 months |
| Health-related quality of life (PROMIS-GH-10) | In the form of a questionnaire | Measured at baseline, 3 months, 6 months and 12 months |
| Health-related quality of life (EQ-5D-5L) | In the form of a questionnaire | Measured at baseline, 3 months, 6 months and 12 months |
| Self-reported number of days with sick leave | In the form of a questionnaire | Measured at baseline, 3 months, 6 months and 12 months |
| Co-interventions (pharmacological and non-pharmacological) | In the form of a questionnaire | Measured at baseline, 3 months and 12 months |
| Global perceived effect (7-point Likert scale) | In the form of a questionnaire | Measured at 3 months, 6 months and 12 months |
| Patients' satisfaction with treatment (7-point Likert scale) | In the form of a questionnaire | Measured at baseline, 3 months and 12 months |
| Success of blinding | In the form of a questionnaire | Measured at 3 months and 12 months |
| Compliance | A pill count will be conducted | Measured at 3 months |
| Pain self-efficacy (Pain Self-Efficacy Questionnaire) | In the form of a questionnaire | Measured at baseline, 3 months, 6 months and 12 months |
| Sleep questionnaire (Pittsburgh Sleep Quality Index) | In the form of a questionnaire | Measured at baseline, 3 months, 6 months and 12 months |
| Neuropathic pain (PainDETECT) | In the form of a questionnaire | Measured at baseline, 3 months, 6 months and 12 months |
| Cost questionnaires (Medical Consumption Questionnaire) | In the form of a questionnaire | Measured at 3 months, 6 months and 12 months |
| Cost questionnaires (Productivity Cost Questionnaire) | In the form of a questionnaire | Measured at 3 months, 6 months and 12 months |
| Gut microbiome composition | The possible collateral impact of antibiotics on the microbiome would be investigated by comparing the abundance and diversity of microbial and resistome composition between patients in amoxicillin and placebo groups. They would be characterized using whole shotgun and functional metagenomic sequencing data (Dhariwal et al. Gut Microbes, 2023). In short, stools of the patients will be collected at baseline, 3 months, and 12 months. From these samples, the microbial DNA will be extracted using a commercial kit. Libraries for shotgun metagenomic sequencing would be prepared using Ilumina sequencing platform. Low quality and adapter sequences from paired-end reads will be filtered, and human DNA contaminant sequences will be discarded. The high-quality reads will be subjected to taxonomic classification. CARD antimicrobial resistance database will be used to annotate metagenomic reads. | Measured at baseline, 3 months, and 12 months |
| Background |
| Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available. |
| 23404353 | Background | Albert HB, Sorensen JS, Christensen BS, Manniche C. Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. Eur Spine J. 2013 Apr;22(4):697-707. doi: 10.1007/s00586-013-2675-y. Epub 2013 Feb 13. |
| 31619437 | Background | Braten LCH, Rolfsen MP, Espeland A, Wigemyr M, Assmus J, Froholdt A, Haugen AJ, Marchand GH, Kristoffersen PM, Lutro O, Randen S, Wilhelmsen M, Winsvold BS, Kadar TI, Holmgard TE, Vigeland MD, Vetti N, Nygaard OP, Lie BA, Hellum C, Anke A, Grotle M, Schistad EI, Skouen JS, Grovle L, Brox JI, Zwart JA, Storheim K; AIM study group. Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial. BMJ. 2019 Oct 16;367:l5654. doi: 10.1136/bmj.l5654. |
| 29971708 | Background | Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3. |
| 30078376 | Background | Agamennone V, Krul CAM, Rijkers G, Kort R. A practical guide for probiotics applied to the case of antibiotic-associated diarrhea in The Netherlands. BMC Gastroenterol. 2018 Aug 6;18(1):103. doi: 10.1186/s12876-018-0831-x. |
| 27130655 | Background | Jafarnejad S, Shab-Bidar S, Speakman JR, Parastui K, Daneshi-Maskooni M, Djafarian K. Probiotics Reduce the Risk of Antibiotic-Associated Diarrhea in Adults (18-64 Years) but Not the Elderly (>65 Years): A Meta-Analysis. Nutr Clin Pract. 2016 Aug;31(4):502-13. doi: 10.1177/0884533616639399. Epub 2016 Apr 29. |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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