The effectiveness of adding 18F-FDG PET/MRI to standard clinical care in patients with chronic low back or hip pain

Chronic pain is an immense burden for patients and the healthcare system
globally, mainly due to a delay in treatment, sub-optimal treatment or no
treatment at all.

Part of these inadequate treatment strategies are due to the fact that pain
generators can be identified poorly by conventional imaging methods. Recently,
it has been shown that advanced molecular imaging methods, like
18F-fluorodeoxyglucose (18F-FDG) PET/MRI are able to identify and precisely
locate pain generators by visualizing metabolic changes induced by pain.
Further assessment of the added value of 18F-FDG PET/MRI to standard clinical
care is needed.

Specific pain entities in which an advantage of 18F-FDG PET/MRI is expected are
chronic low back and hip pain. Both are common pain entities, frequently with a
pain generator that could be located in a large variety of affected structures
and, moreover, in a large region of the body.

This project aims to study the effectiveness of adding 18F-FDG PET/MRI
to standard clinical care in patients with chronic low back or hip pain.
Secondary objectives encompass exploration of the change in metabolic activity
on 18F-FDG PET/MRI after treatment and the association of those changes with
established measurements for pain and inflammation.

Open pragmatic diagnostic randomized clinical trial

Injectiin MRI-contrast; Injection 18F-FDG forPET ; Bloodsample collection.

The 18F-FDG PET/MRI group will visit the hospital twice for a questionnaire,
pain perception testing, venous blood sample and 18F-FDG PET/MRI examination at
baseline. In a subgroup of patients, 18F-FDG PET/MRI will be repeated 6 months
after treatment, if the treatment was specifically targeted at the pain
generator identified by PET/MRI.

During the other follow-up moments at 1, 3 and 12 months after treatment they
will only complete an online questionnaire. The burden for 18F FDG PET/MRI is
administration of radioactive tracer 18F-FDG.

The burden for the concomitant MRI is gadolinium-based contrast agent Gadovist.
Both are administered to patients in daily clinical care in our hospital and
are associated with only a very small risk of side effects.

Thus, we believe that the burden and the concomitant risks are outweighed by
the expected benefit of identification of the exact pain generator which can
subsequently be treated specifically. The control group will receive standard
clinical care supplemented with a questionnaire at baseline and 1, 3, 6 and 12
months after treatment