PROJECT

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Anti-inflammatory drugs for long-term low back pain and Modic changes

project manager

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postdok

phd fellow

About the project

Modic changes are changes in the vertebrae that are visible on MRI. There are various theories as to why these changes occur. One of several possible explanations for Modic changes is that they occur as a result of an inflammatory reaction (inflammation). This study investigates this theory. In the study, we treat patients with an anti-inflammatory drug (infliximab). To better understand the underlying factors for low back pain, and to explain any treatment effect of infliximab, we take blood samples and study various biological markers.

Who can participate?

Recruitment in the study has been completed.

The main criteria for participating in the study are:

  1. age between 18 and 65 years
  2. low back pain that has persisted for at least 6 months
  3. Modic type 1 visible on MRI image

Project arrangement

If you are offered the opportunity to participate in the study and accept, you will receive treatment with either active drug (infliximab) or placebo. What you receive will be decided by drawing lots via a computer. Neither you nor the study personnel accompanying you will know whether you receive active drug or placebo.

The treatment is given as an infusion (i.e. the medicine is given intravenously). You will receive 4 treatments over a period of 14 weeks. Treatment takes place at the hospital that includes you, and you should allow approximately 4-5 hours per treatment.

In addition to 4 treatments, you must attend a medical check-up at the hospital 22 weeks after the first treatment was given.

There will also be a follow-up check-up by phone 9 months after the first treatment.

During the course of the study, you will have blood samples taken 6 times, 2 MRI scans and answer regular electronic questionnaires.

Everything will happen over a period of 10-11 months.

Partners

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