Treatment of osteoporosis with unfocused extracorporeal shock wave therapy: pilot study

Osteoporotic fractures have a high morbidity and mortality. This is why
prevention of these fractures is important. Today's standard treatment is
lifestyle modifications in combination with bisphosphonates, which results in
prevention of further bone loss. We have shown in animal studies that one-time
treatment with unfocused extracorporeal shock wave therapy (UESWT) leads to
bone formation. This could be an interesting clinical implication for the
prevention of osteoporotic fractures.

A clinical pilot-study were we will look if one time shock wave therapy on the
distal radius leads to an increased bone mass. At the same time we would like
to study if shock wave therapy of the distal radius could result in
complications and we would like to generate new data which is essential for
large scale studies.

Female patients who are on the operation list waiting for a procedure on the
lower extremity or spine under general anaesthesia at the department of
orthopaedics of the UMC Utrecht in the age of 50 and 80 years, will be
contacted about the study by the researcher. We will inform the patient about
the study and invite them to participate. If they are interested the researcher
will screen on inclusion and exclusion criteria and schedule an appointment
before or after one of the patients other appointments in our hospital before
the operation (eg. anaesthesiologist or a nurse practisioner). The appointments
will be centred at study office hours. The patient will receive written
information and a questionnaire by mail. At the appointment the patient will be
further screened on in-and exclusion criteria, also with the questionnaire.
When the patient fulfils the inclusion criteria and gives written informed
consent, the baseline measurements will be carried out. Thereafter the patient
will be randomized in either left or right limb treatment and X-ray exams and
DXA-scans are made. The attending physician will be informed about the
treatment allocation. During the operation on the lower extremity patient is
treated with 3000 extracorporeal shock waves with an EFD of 0.3 mJ/mm2 at one
wrist. This will be done in a single blind manner, so that the subject does not
know which site has been treated. The effect of one-time unfocused
extracorporeal shock wave therapy will be measured in different ways. First, we
will make a dual energy X-ray absorptiometry (DXA)-scan of the treated and
control site at six and twelve weeks after unfocused extracorporeal shock waves
to examine bone mineral density of the distal forearm to follow the effect in
time. The pain at the wrist will be objectified before the operation and during
the first week with a diary (three times daily). We will perform clinical and
physical examination of the wrists at the clinical department of orthopaedics
the day after the operation or before they leave the hospital if they leave the
hospital the day of the operation. After UESWT an X-ray is only made on
indication. In total we will treat 12 patients.

Patients will recieve 3000 unfocused shock waves with an energy flux density of
0.30,3mJ/mm2 to one of both wrists.

Unfocused shock wave therapy (UESWT) is a non-invasive therapeutic modality
without surgery or surgical risks. It has only been used in other areas like
wound healing, without any complications described so far. There are positive
effects of UESWT in wound healing, where UESWT-treated ulcers showed
significant improvement in blood flow perfusion rate. UESWT also showed
increases in cell proliferation and decreases in cell apoptosis. Safe use of
ESWT has even expanded to cardiovascular medicine.
The use of ESWT steadily increases over the years. The only side effects of
ESWT are local reddening, ecchymosis, or mild hematoma, which have a low rate
and are easily conservativly managed with success.
With lithotripsy (kidney stone disintegration), which uses focused shock waves,
the rarely described side effects are hematomas, deep vein thrombosis, fat
embolism, and pulmonary embolism or neurovascular complication. Because this
treatment is of a complete different modality and at a different region of the
body, we do not expect to see any of these side effects.
As said, shock wave therapy has emerged as a good and safe choice in the
treatment of many orthopaedic disorders.

The burden for the patient is low, because the pain is controlled during the
treatment because of the general anesthesia and afterwards with pain medication
according to the standard post-operative protocols used in the UMC Utrecht, but
ofcourse depending on the type of lower extremity surgery that is performed.
The measurements (DXA-scan en X-rays) have very low radiation risks and the
appointments are scheduled together with the pre- and post-operative planned
appointments, so the patients do not have to come more times then necessary to
the hospital.

This pilot study is a kind of 'proof of principle', but it is definately
performed with clear vision of clinical implications for the prevention of all
osteoporotic bone fractures.