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

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 examines this theory. In the study, we treat the patients with an anti-inflammatory drug (infliximab). To better understand underlying factors for low back pain, and to explain a possible treatment effect of infliximab, we take blood samples and study various biological markers.

WHO CAN JOIN?

Recruitment in the study has ended.

The most important 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 MR image

WHAT DOES THE STUDY INCLUDE?

If you are offered to participate in the study, and accept, you will receive treatment with either the active drug (infliximab) or a placebo. What you get is decided by a lottery via a computer. Neither you nor the study staff accompanying you will know whether you are receiving an active drug or a placebo.

The treatment is given as an infusion (ie the medicine is given intravenously). You get 4 treatments over a period of 14 weeks. Treatment takes place at the hospital that includes you, and you must calculate approx. 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 by telephone 9 months after the first treatment.

During the course of the study, blood samples will be taken from you 6 times, you will take 2 MRI images, as well as answer regular electronic questionnaires.

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