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Extracorporeal Shock Wave
Treatment for Chronic Proximal Plantar Fasciitis
What is extracorporeal shock wave (ESW) treatment?

Extracorporeal" means "outside the body." Shock waves are created by very strong acoustic (sound) energy. Your ESW treatment will be performed with a device called the OssaTron.

The OssaTron is a shock wave generator very similar to the shock wave devices used to treat kidney stones without surgery. The shock waves are created by a spark plug that is enclosed in a soft plastic dome filled with water. During ESW treatment, this dome is placed close against the heel so that the shock waves pass through the dome to the heel. ESW treatment has been found to be effective for treating chronic proximal plantar fasciitis, a condition that causes pain in the heel of the affected foot and is sometimes calle "heel spurs."
Who should not have ESW treatment for proximal plantar faciitis?

• Anyone taking medications that may prolong or interfere
with blood clotting should not have ESW treatment.
• Anyone with a history of bleeding problems should
not have ESW treatment.
• Children should not have ESW treatment.
• Pregnant women should not have ESW treatment.
Because the OssaTron has not been tested on peoplewho have the following conditions, its effect, safety, andeffectiveness on someone who has one of the followingconditions is unknown:
• Tarsal tunnel syndrome or other nerve entrapment
disorders (damage or pressure on the nerves to the foot)
• Diabetic neuropathy (nerve damage due to diabetes)
• Fracture of the foot or ankle
• Significant peripheral vascular disease (problems with
the circulation in the blood vessels in the legs)
• Severe osteoarthritis
• Rheumatoid arthritis
• Osteoporosis
• Metabolic disorders
• Malignancies
• Paget’s disease
• Osteomyelitis
• Systemic infection
Your doctor can provide you with additional informationabout these and other conditions and how they mightaffect the decision to perform ESW treatment.

What side effects and complications could happen?
• The ESW treatment may cause skin reddening or bruising of the treated foot.This usually clears within a few days.
• The ESW treatment may cause numbness or tingling in the treated foot.
• The ESW procedure may cause the plantar fascia to tear.
• The ESW treatment may not help heel pain in your case.
You may have episodes of pain similar to the pain you had before treatment. The pain may continue for a few days to several weeks after treatment.
• Shock waves directed at large blood vessels or major nerves may cause damage to these structures. Misdirected ESW may result in nerve or blood vessel injury.
What will happen on the day of the ESW treatment?

Your doctor will probably ask you to come to the hospitalor surgery center a few hours before your ESW treatment isscheduled. You should wear shorts or loose fitting clothingthat can easily be rolled up to the knee of your affected leg.Otherwise, you may be asked to change from your ownclothes into a hospital gown. The staff may take your tem-perature,pulse and blood pressure and ask you some ques-tionsabout your general health. They also will make sure youhave signed a consent form for the ESW treatment.

The ESW treatment may cause some pain or discomfort, so an anesthetic is commonly given before the procedure. Usually, this is a local anesthetic or a regional anesthetic called a heel block. During the ESW treatment, you will be asked to rest comfortably on your back while your doctor holds your foot up to the OssaTron shock head as shown on the Treatment Page.

An ESW treatment for chronic proximal plantar fasciitis usually takes about 30 minutes. The ESW treatment is performed as an outpatient procedure. No overnight hospital stay is necessary.
What will happen after the ESW treatment?
Immediately after treatment, you will stay at the hospital or surgery center until the anesthetic wears off enough that it is safe for you to walk. Your doctor will probably ask you to restrict “stressful activity” involving the treated foot for four weeks after treatment. “Stressful activity” may include running or jogging, doing heavy housework or yard work, and participating in sports. Some patients need a mild pain medication following ESW treatment. Although some patients in the clinical study felt immediate relief from pain after the ESW treatment, it is more common for it to take up to six weeks for pain relief to begin.
What are the expected results from ESW treatment?

In the OssaTron clinical study, patients with chronic proximal plantar fasciitis were graded “Success” or “Fail” according to four measurements:
1) The doctor graded the amount of pain with pressure on the heel;
2) the patient graded the amount of pain during walking first thing in the morn-ing;
3) the patient graded the time and distance he or she could walk without pain and
4) the patient reported the amount of pain medication he or she needed for heel pain.
Percentage of Patients with Successful Outcome at 12 Weeks
RESULTS AT 12 WEEKS
Measurment
OssaTron
Treatment
(n=119)
Placebo
Treatment
(n=116}
Investigator Assesment
62.2%
Self Assesment (pain in a.m.)
60%
48%
Activity Level
71%
67%
Medication Use
70%
65%
Composite (all four components)
47%
30%

Your doctor will ask you to return to the office for aup visit, six or eight weeks after your OssaTron treatment. Please check with your doctor about this follow up
I have more questions about ESW treatment for heel pain. How can I get more information?

Talk to your doctor. In order to use the OssaTron tochronic proximal plantar fasciitis, your doctor had t complete a specialized training program. The traini program not only allowed your doctor to learn how perform the ESW treatment, but it also included infor about shock wave energy in general, and informatio the OssaTron clinical study. Therefore, your doctor is best person to talk with if you have any questions o concerns about ESW treatment for chronic proxima plantar fasciitis with the OssaTron.
What other treatments are available for treating chronic proximal plantar fasciitis?

Doctors know that many people who have heel pain get better with time, even with no treatment. Many other people get better after trying one or several conservative treatments, which include:
• Rest from excessive or abusive activity and the application of heat or cold
• Physical conditioning exercises
• Use of a shoe insert or heel cup
• Physical therapy, including ultrasound therapy
• Over-the-counter pain relievers, such as aspirin or
Tylenol (acetaminophen)
• Prescription pain relievers
• Non-steroidal anti-inflammatory medications (NSAIDs),
such as Advil (ibuprofen) or Aleve (naproxen)
• Steroid injections (cortisone)
In difficult cases of chronic proximal plantar fasciitis, open or arthroscopic surgery may be performed.
Who should consider having ESW treatment for proximal plantar fasciitis?

ESW treatment with the OssaTron is for patients who have had heel pain for at least six months and who have tried other methods for treating their heel pain. In the OssaTron clinical study, the treated patients had failed to respond to at least three attempts at conservative treatment: two prior courses of non-invasive treatment, including physical therapy and the use of an orthotic device; and one prior course of pharmacological treatment. ESW treatment with the OssaTron is for patients who can tolerate anesthesia prior to the ESW procedure. ESW treatment with the OssaTron is painful. ESW treatment with the OssaTron is for patients who can tolerate hearing protection to reduce the risk of hearing impairment due to the sound of the OssaTron.