(see also Plantar Fasciitis )
But, does it work? See the published study at the end of this article.
A new outpatient treatment is available for patients who have plantar fasciitis. In October 2000, the US Food and Drug Administration (FDA) approved an extracorporeal shock wave (ESW) device (OssaTron, HealthTronics Inc, Marietta, Georgia) for chronic proximal plantar fasciitis that has not responded to 6 months of conventional treatment.
The patient's heel is placed against a water-filled dome that houses a spark plug. A single ESW treatment delivers 1,000 to 1,500 shocks at 18,000 volts over 30 minutes. The treatment is painful and requires local anesthesia or a heel block and ear protection from the sound made by the device.
The FDA approval was based on a placebo-controlled clinical trial of 320 patients who had not responded to standard plantar fasciitis treatments. Treatment was considered successful in 47% of the study group and 30% of the placebo group; on average, pain was reduced by 89%.
The FDA is requiring further study to evaluate adverse effects. Misdirected ESW may result in damage to large blood vessels and major nerves. In a clinical study of the device, a small number of patients (0.6%) sustained plantar fascia tears. ESW treatment is contraindicated for children, pregnant women, and patients who have a history of bleeding problems or who are on medications that interfere with clotting.
After treatment, patients are asked to curtail stressful activity (such as running, jogging, heavy housework, or yard work) for 4 weeks and are advised that they may not experience pain relief for up to 6 weeks following treatment. At 12-month follow-up, some patients report a significant (up to 99%) reduction in pain and no limitation of activities.
Anthony Galea, MD, a sports medicine physician and director of sports medicine at Lifemark Health, based in Toronto, says ESW treatment (also known as orthotripsy) has been used in Canada and Europe over the past few years for plantar fasciitis, epicondylitis, calcific tendinitis, and stress fractures. Galea estimates that he's used ESW to treat about 160 patients with chronic plantar fasciitis and estimates that he's had about an 80% success rate. He says his center's success rate is higher than that of the FDA study because he prescreens patients: To qualify for treatment, the plantar fascia must be thicker than 4 mm as measured on ultrasound. Galea says it's thought that the therapeutic effect of ESW treatment occurs when tiny bubbles invade and explode into tissues, causing microtrauma followed by rehealing.
Lloyd Nesbitt, DPM, a podiatrist in private practice in Toronto, says ESW treatment appears to be useful in the treatment of chronic plantar fasciitis. "In about 95% of cases there are biomechanical imbalances that you can usually correct with conventional treatments such as taping, orthotics, ice, physical therapy and massage" he says. "But there is a place for it [ESW treatment] in the clinical setting."
The machines are currently in use in 16 states and Toronto. The device is also being evaluated as a treatment for nonunion fractures.
Lisa Schnirring; Patricia D. Mees
FROM: THE PHYSICIAN AND SPORTSMEDICINE - VOL 29 - NO. 3
Heel Pain Treatment Said Ineffective
The condition, known medically as plantar fasciitis, affects
more than 2 million Americans and is common in runners. It can include heel
spurs, or bony growths that form after repeated injuries or inflammation.
Standard treatments include anti-inflammatory drugs, over-the-counter heel cushions and sometimes surgery.
The new treatment employs noninvasive technology more commonly used to break up kidney stones and can cost $2,000 or more. The sound waves are believed to work by breaking up the heel spurs or easing tissue-thickening.
Australian researchers studied 160 patients given three weekly treatments or three doses of dummy therapy. Both groups improved significantly afterward, the researchers said, led by Dr. Rachelle Buchbinder of Cabrini Medical Center in Victoria, Australia.
The findings appear in Wednesday's Journal of the American Medical Association.
The researchers tested a device called EPOS Ultra, made by Munich-based Dornier MedTech. It involves applying bursts of sound-wave pressure to the heel and was approved in January by the Food and Drug Administration after company-led studies showed it to be effective.
Kirk Wilks, marketing director for Dornier MedTech America, the company's Western Hemisphere distributor, said the Australian study is flawed because placebo patients received similar treatment but at much lower doses. Both groups also were allowed to continue wearing splints or other already prescribed devices.
Wilks said 21 machines have been sold in the United States since January. The devices are used worldwide, most commonly in Europe.
As published in the InteliHealth Health News, September 18, 2002