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 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 closed against the heel so that the shock waves pass through the dome to the heel. ESW
treatment has recently 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 called "heel spurs".
Who Should not have ESW treatment for proximal plantar fasciitis?
- 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 people who have the
following conditions, its effect, safety, and effectiveness on someone who has one of the following
conditions 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 then 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 information about these
and other conditions and how they might affect 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 might 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 hospital or surgery
center a few hours before your ESW treatment is scheduled. You should wear shorts or loose fitting
clothing that can easily be rolled up to the knee of your affected leg. Otherwise, you may be asked
to change from your own clothing into a hospital gown. The staff may take your temperature, pulse
and blood pressure and ask you some questions about your general health. They also will make sure
you have 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 call a heel block. During the ESW treatment, you will be asked to rest comfortably on
your back while the doctor holds your foot up to the OssaTron shock head as shown on the front of
this pamphlet.
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.
EXTRACOORPOREAL SHOCK WAVE
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 wit pressure on the heel; 2) The patient graded the amount of pain during
walking first thing in the morning; 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
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RESULTS AT 12 WEEKS
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Measurement
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OssaTron Treatment (n=119)
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Placebo Treatment(n=116)
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Investigator Assessment
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62.2%
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44%
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Self Assessment (pain in a.m.)
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60%
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48%
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Activity Level
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71%
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67%
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Medication Use
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70%
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65%
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Composite (all four components)
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47%
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30%
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Your doctor will ask you to return to the office for a follow up
visit, six or eight weeks after your OssaTron treatment. Please check with you doctor about this
follow up visit.
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 to treat chronic
proximal plantar fasciitis, your doctor had to complete a specialized training program. The
training program not only allowed your doctor to learn how to perform the ESW treatment, but it
also included information about shock wave energy in general, and information from the OssaTron
clinical study. Therefore, your doctor is the best person to talk with if you have any questions or
concerns about ESW treatment for chronic proximal 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 on e of several
conservative treatments. Which include:
- Rest from excessive or abusive activity ant 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)
- Non0sterodial 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.
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Text Source:
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HealthTronics, Inc.
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1841 W. Oak Parkway, Suite A.
Marietta, GA 30062
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