MSK ConditionsPhase 3ABBANCT06771492
Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
A Phase 3 study testing Amoxicillin in people with MSK Conditions and Chronic Low Back Pain (CLBP), run by Bart Koes at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- MSK Conditions, Chronic Low Back Pain (CLBP), Modic Changes
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Apr 2025to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
About this study
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:
Read more
- 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
- Being tested
- Amoxicillin, Placebo
- Keywords
- Antibiotics, Amoxicillin, Low back pain (LBP), Modic changes, Randomized controlled trial
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Antibiotic treatment (amoxicillin) with a dosage of 1000 mg (3 times a day) for a period of 100 days
PlaceboOther
Placebo with a dose of 1000 mg (3 times a day) for a period of 100 days
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic treatment (amoxicillin) | Experimental | A dose of 1000 mg (3 times a day) for a period of 100 days Receives: Drug: Amoxicillin |
| Placebo | Placebo comparator | A dose of 1000 mg (3 times a day) for a period of 100 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The measurements are scheduled at baseline and at 3, 6 and 12 months follow-up.
Secondary outcomes (16)
LBP-intensity (0-10 NRS-scale)
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Leg pain intensity (0-10 NRS-scale)
In the form of a questionnaire
Measured: 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: 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: 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: Measured at baseline, 3 months, 6 months and 12 months
Co-interventions (pharmacological and non-pharmacological)
In the form of a questionnaire
Measured: Measured at baseline, 3 months and 12 months
Global perceived effect (7-point Likert scale)
In the form of a questionnaire
Measured: Measured at 3 months, 6 months and 12 months
Patients' satisfaction with treatment (7-point Likert scale)
In the form of a questionnaire
Measured: Measured at baseline, 3 months and 12 months
Success of blinding
In the form of a questionnaire
Measured: Measured at 3 months and 12 months
Compliance
A pill count will be conducted
Measured: Measured at 3 months
Pain self-efficacy (Pain Self-Efficacy Questionnaire)
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Sleep questionnaire (Pittsburgh Sleep Quality Index)
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Neuropathic pain (PainDETECT)
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Cost questionnaires (Medical Consumption Questionnaire)
In the form of a questionnaire
Measured: Measured at 3 months, 6 months and 12 months
Cost questionnaires (Productivity Cost Questionnaire)
In the form of a questionnaire
Measured: 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: Measured at baseline, 3 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start2 Apr 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MSK ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bart Koes
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus University Rotterdam
- Responsible party
- Sponsor-investigator, Bart Koes, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771492
- Sponsor's protocol ID
- 2024-515824-35
- Other IDs
- 2024-515824-35-01
- Acronym
- ABBA
- Status last verified
- Sep 2026
- First submitted
- 21 Nov 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 30496104Chiarotto 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.
PubMed 35507483Albert 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.
PubMed 23404353Braten 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.
PubMed 31619437Oliveira 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.
PubMed 29971708Agamennone 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.
PubMed 30078376Jafarnejad 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.
PubMed 27130655
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06771492
- Acronym / sponsor ID
- ABBA / 2024-515824-35
- Conditions
- MSK Conditions, Chronic Low Back Pain (CLBP), Modic Changes
- Keywords
- Antibiotics, Amoxicillin, Low back pain (LBP), Modic changes, Randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Bart KoesUniversity, hospital or other
- Collaborators
- Erasmus University Rotterdam
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic treatment (amoxicillin) | Experimental | Drug: AmoxicillinA dose of 1000 mg (3 times a day) for a period of 100 days |
| Placebo | Placebo comparator | Other: PlaceboA dose of 1000 mg (3 times a day) for a period of 100 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmoxicillinAntibiotic treatment (amoxicillin) with a dosage of 1000 mg (3 times a day) for a period of 100 days | Drug | Antibiotic treatment (amoxicillin) |
| PlaceboPlacebo with a dose of 1000 mg (3 times a day) for a period of 100 days | Other | Placebo |
Primary outcome
Roland Morris Disability Questionnaire (RMDQ)
Time frame: The measurements are scheduled at baseline and at 3, 6 and 12 months follow-up.
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.
16 secondary outcomes
LBP-intensity (0-10 NRS-scale)
Time frame: Measured at baseline, 3 months, 6 months and 12 months
Leg pain intensity (0-10 NRS-scale)
Time frame: Measured at baseline, 3 months, 6 months and 12 months
Health-related quality of life (PROMIS-GH-10)
Time frame: Measured at baseline, 3 months, 6 months and 12 months
Health-related quality of life (EQ-5D-5L)
Time frame: Measured at baseline, 3 months, 6 months and 12 months
Self-reported number of days with sick leave
Time frame: Measured at baseline, 3 months, 6 months and 12 months
Co-interventions (pharmacological and non-pharmacological)
Time frame: Measured at baseline, 3 months and 12 months
Global perceived effect (7-point Likert scale)
Time frame: Measured at 3 months, 6 months and 12 months
Patients' satisfaction with treatment (7-point Likert scale)
Time frame: Measured at baseline, 3 months and 12 months
Success of blinding
Time frame: Measured at 3 months and 12 months
Compliance
Time frame: Measured at 3 months
Pain self-efficacy (Pain Self-Efficacy Questionnaire)
Time frame: Measured at baseline, 3 months, 6 months and 12 months
Sleep questionnaire (Pittsburgh Sleep Quality Index)
Time frame: Measured at baseline, 3 months, 6 months and 12 months
Neuropathic pain (PainDETECT)
Time frame: Measured at baseline, 3 months, 6 months and 12 months
Cost questionnaires (Medical Consumption Questionnaire)
Time frame: Measured at 3 months, 6 months and 12 months
Cost questionnaires (Productivity Cost Questionnaire)
Time frame: Measured at 3 months, 6 months and 12 months
Gut microbiome composition
Time frame: Measured at baseline, 3 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 30496104GBD 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.
- Background: PubMed 35507483Chiarotto 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.
- Background: PubMed 23404353Albert 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.
- Background: PubMed 31619437Braten 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.
- Background: PubMed 29971708Oliveira 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.
- Background: PubMed 30078376Agamennone 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.
- Background: PubMed 27130655Jafarnejad 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amoxicillin in people with MSK Conditions and Chronic Low Back Pain (CLBP), run by Bart Koes at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland Morris Disability Questionnaire (RMDQ) (time frame: The measurements are scheduled at baseline and at 3, 6 and 12 months follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06771492, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.