Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial

NCT06771492 | Recruiting Phase 3

• 2 other identifiers: 2024-515824-352024-515824-35-01
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• What is the efficacy (primary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?
• What is the cost-effectiveness (secondary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes? 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:
• Be invited for an MRI scan to determine if they have a Modic type I change; those who do will be included in the study.
• Take either amoxicillin or a placebo daily for 100 days.
• Take probiotics daily for 100 days to reduce the occurrence and impact of any side effects from the antibiotics.
• Attend clinic visits at baseline (the start), 4 weeks, 3 months, and 12 months for checkups and tests.
• Complete questionnaires at baseline, 3 months, 6 months, and 12 months.

Conditions

MSK Conditions; Chronic Low Back Pain (CLBP); Modic Changes

Keywords

Antibiotics; Amoxicillin; Low back pain (LBP); Modic changes; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (16)

• LBP-intensity (0-10 NRS-scale)

  Measured at baseline, 3 months, 6 months and 12 months

• Leg pain intensity (0-10 NRS-scale)

  Measured at baseline, 3 months, 6 months and 12 months

• Health-related quality of life (PROMIS-GH-10)

  Measured at baseline, 3 months, 6 months and 12 months

• Health-related quality of life (EQ-5D-5L)

  Measured at baseline, 3 months, 6 months and 12 months

• Self-reported number of days with sick leave

  Measured at baseline, 3 months, 6 months and 12 months

Study Arms (2)

Antibiotic treatment (amoxicillin)

EXPERIMENTAL

A dose of 1000 mg (3 times a day) for a period of 100 days

Drug: Amoxicillin

Placebo

PLACEBO COMPARATOR

A dose of 1000 mg (3 times a day) for a period of 100 days

Other: Placebo

Interventions

Amoxicillin DRUG

Antibiotic treatment (amoxicillin) with a dosage of 1000 mg (3 times a day) for a period of 100 days

Antibiotic treatment (amoxicillin)

Placebo OTHER

Placebo with a dose of 1000 mg (3 times a day) for a period of 100 days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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":
• Does training and/or exercise increase your pain?
• Is your sleep during the night disturbed due to your back pain?
• Is it painful to turn over in bed at night?
• Do you suffer from morning pain?
• 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.

You may not qualify if:

• Received antibiotic treatment in the past month.
• Current pregnancy, lactation or pregnancy-wish.
• Severe physical or psychiatric co-morbidities.
• LBP resulting from a specific cause such as a tumor or fracture.
• Surgery or epidural injection in the past 6 months.
• Previous antibiotic course of 100 days.
• Contra-indication for amoxicillin use: allergy to penicillins/amoxicillin, cephalosporin or carbapenem; mononucleosis; leukemia; phenylketonuria (PKU)
• Contra-indication for MRI.
• Current use of any of the following medications: allopurinol, methotrexate, phenylbutazone or probenecid.
• Hepatic or renal (eGFR≤30) impairment.
• Inability to swallow capsules.

Sponsors & Collaborators

• Bart Koes: lead
• Erasmus University Rotterdam: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Related Publications (7)

• 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.

  PMID: 30496104 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.

  PMID: 35507483 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.

  PMID: 23404353 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.

  PMID: 31619437 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.

  PMID: 29971708 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.

  PMID: 30078376 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.

  PMID: 27130655 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Tamana Meihandoest, MSc

CONTACT

+31627571742; t.meihandoest@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: January 13, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)