What is the Modic Trial?

Recruitment of patients into the trial is now complete.

The Modic Trial is a clinical trial of an antibiotic to find out if a new medication can treat Chronic Low Back Pain.

The trial is also known as “Persica 002 (A phase 1b study investigating the safety, tolerability and efficacy of PP353 in the treatment of patients with chronic low back pain associated with vertebral body endplate bone oedema (Modic 1)).”

Chronic Low Back Pain is a common condition which can severely impact someone’s life. Many of the existing treatment options for Chronic Low Back Pain do not work well and the regular use of strong pain killers is common.

There is evidence that damage to vertebral discs in someone’s spine can allow an infection to get into the disc which can then cause Chronic Low Back Pain – much like tooth decay we now have “disc decay”.

It may seem strange to think that bacteria can get into a spinal disc and that antibiotics might be able to reduce that pain. However, in patients with a slipped disc (known as disc herniation) the outer tough rings of the disc split open, and some of the soft gel in the centre of the disc-the nucleus–breaks through the outer rings. Bacteria are then able to enter the disc via the bloodstream.

This infection is a slow process and causes inflammation, bone loss and swelling (oedema) in the bones either side of the infected disc. The swelling of these vertebral bones can be seen by Magnetic Resonance Imaging (MRI) and are called Modic changes.

Several clinical trials have shown that long term treatment of 100 days with high dose oral antibiotics can reduce pain and disability in patients with Chronic Low Back Pain. This long and high dose antibiotic treatment is thought to be necessary because discs do not normally have any blood vessels and it is difficult for the antibiotics to get into the infected area and kill the bacteria. Unfortunately, patients treated with long term oral antibiotics also frequently experience unpleasant side effects. There are also concerns with long term antibiotic use and bacteria becoming resistant to the antibiotics.  The Modic trial will use an antibiotic that is injected directly into the spinal disc.

This is the first research trial using this drug and it will find out if the drug reduces back pain and is safe to use.