Study on Amoxicillin for Patients with Chronic Low Back Pain and Modic Type I Changes

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What is this study about?

This clinical trial is focused on studying the effectiveness of antibiotic treatment for patients suffering from chronic low back pain with specific changes in their spine known as Modic type I changes. These changes are visible on an MRI scan, which is a type of imaging that helps doctors see inside the body. The treatment being tested is amoxicillin, a commonly used antibiotic, in the form of 500 mg film-coated tablets. The study will compare the effects of taking amoxicillin to taking a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of the study is to determine if taking amoxicillin for three months can help reduce pain and improve the quality of life for people with chronic low back pain and Modic type I changes. Participants in the study will be randomly assigned to receive either the amoxicillin tablets or the placebo. They will take the tablets daily for a period of three months. Throughout the study, participants will be asked to report on their pain levels, any changes in their ability to perform daily activities, and their overall satisfaction with the treatment.

Participants will also undergo follow-up assessments, including another MRI scan after 12 months, to see if there are any changes in the Modic type I changes in their spine. The study aims to provide valuable information on whether antibiotics like amoxicillin can be an effective treatment option for this type of chronic back pain. The results could potentially lead to new treatment guidelines for patients experiencing similar symptoms.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose, which is to assess the effectiveness of a three-month antibiotic treatment with amoxicillin compared to a placebo for chronic low back pain with specific changes visible on an MRI scan.

You will be asked to provide consent to participate in the study after understanding the potential risks and benefits.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are between 18-65 years old, have had chronic low back pain for more than six months, and meet other specific criteria related to your pain and MRI results.

You will be asked questions about your pain levels, sleep disturbances, and other symptoms to ensure you meet the study’s requirements.

3 randomization

You will be randomly assigned to one of two groups: one receiving amoxicillin 500 mg film-coated tablets and the other receiving placebo amoxicillin capsules 500mg. This process is called randomization and ensures that the study results are unbiased.

Neither you nor the study team will know which group you are in, which is known as a double-blind study.

4 treatment phase

During the treatment phase, you will take the assigned medication orally three times a day for a duration of three months.

You will be required to keep a record of your medication intake and any side effects you experience.

5 regular check-ins

Throughout the trial, you will have regular check-ins with the study team to monitor your progress and any changes in your condition.

You will be asked to complete questionnaires about your pain levels, disability, quality of life, and other health-related factors.

6 final assessment

At the end of the three-month treatment period, a final assessment will be conducted to evaluate the effectiveness of the treatment.

This will include completing the same questionnaires as before and possibly undergoing another MRI scan to assess any changes in your condition.

7 follow-up

A follow-up will be conducted 12 months after the treatment to assess the long-term effects of the treatment on your condition.

You may be asked to complete additional questionnaires and undergo another MRI scan.

Who Can Join the Study?

Aged between 18 and 65 years.
Have chronic low back pain, which means having back pain for more than 6 months.
Previously had a disc herniation (a condition where a disc in the spine is damaged) confirmed by an MRI scan, within the past 6 months to 2 years.
Answer “Yes” to at least 2 of these questions:
- 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?
Have a mean pain intensity of at least 5 points on a 0-10 scale, based on current pain, worst pain in the last two weeks, and usual mean pain in the last two weeks.
Have Modic Type I changes visible on an MRI scan in the vertebrae next to the previously herniated disc. (Modic Type I changes are specific changes in the spine seen on an MRI scan.)

Who Cannot Join the Study?

Patients who do not have chronic low back pain cannot participate.
Patients without Modic type I changes on their MRI cannot participate. Modic type I changes are specific changes in the spine that can be seen on an MRI scan.
Patients who are under 18 years old cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Dxpgiyxucohx	Rotterdam	The Netherlands
Mynwhruzeii	Rotterdam	The Netherlands
Enswrzb Uzbdxckbrdxj Myifzyn Cnbwigu Rucwclyvx (nhpympt Mtt	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	02.09.2024

Trial locations

Investigated drugs:

Amoxicillin

Amoxicillin is an antibiotic that is commonly used to treat various infections caused by bacteria. In this clinical trial, it is being tested to see if it can help people who have chronic low back pain along with specific changes in their spine, known as Modic type I changes, which are visible on an MRI scan. The goal is to determine if taking amoxicillin for three months can reduce pain and improve the condition of these patients.

Investigated diseases:

Back pain

Non-specific low back pain – Non-specific low back pain is a condition characterized by pain in the lower back area that cannot be attributed to a specific underlying disease or anatomical cause. It often results from a combination of factors such as muscle strain, ligament sprain, or poor posture. The pain can vary in intensity and may be accompanied by stiffness or limited range of motion. It typically progresses with episodes of acute pain that may become chronic if not managed properly. The condition can affect daily activities and may lead to periods of discomfort or disability. Over time, it may also influence sleep quality and overall well-being.

Trial ID:

2024-515824-35-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Amoxicillin for Patients with Chronic Low Back Pain and Modic Type I Changes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?