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 closely against the heel so that the
shock waves pass through the dome to the heel. ESW treatment has
recently been found to be effective to treat chronic proximal plantar
fasciitis, a condition that causes pain in the heel of the affected
foot and is sometimes called "heel spurs".
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 (NSAID’s), 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 6 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 causes some pain or discomfort.
Due to the sound of the OssaTron
machinery, patients having ESW treatment with the OssaTron must be
able to use hearing protection devices in order to reduce the risk of
hearing impairment.
Who should NOT
have ESW treatment for proximal plantar fasciitis?
- Anyone taking medications that may prolong or interfere with blood
clotting
- Anyone with a history of bleeding problems
- Children
- Pregnant women
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 the
circulation in the blood vessels in the legs)
- Severe osteoarthritis
- Rheumatoid arthritis
- Osteoporosis
- Metabolic disorders
- Malignancies
- Paget's disease
- Osteomyelitis
- Systemic infection
Dr. Reid and Dr. Kosova can provide you with
additional information about these and other conditions, and how they
might affect the decision to perform ESW treatment.
What are the
side effects and complications that could happen?
- The ESW treatment may cause skin reddening or bruising of the
treated foot, which 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 to large blood vessels or to 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?
Dr. Reid or Dr. Kosova will probably ask you to come to the hospital or surgery
center a few hours before the 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 clothes into a hospital gown. The staff may take your
temperature, pulse and blood pressure and ask you some questions about
your general health. They will also 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 will be a local anesthetic or a regional
anesthetic called a heel block. You will be asked to rest comfortably
on your back while one of our physicians holds your foot up to the OssaTron
shock head.
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 so it is safe for you to
walk. We will probably ask you to restrict stressful activity
involving the treated foot for 4 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 6 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 4
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 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 |
|
Results
at 12 Weeks |
| Method
of Measurement |
OssaTron
Treatment |
Placebo
Treatment |
|
(n=119)
|
(n=116)
|
| Investigator
Assessment |
62.2%
|
44% |
| Self
Assessment, Pain in a.m. |
60% |
48% |
| Activity
Level |
71% |
67% |
| Medication
Use |
70% |
65% |
| Composite
(all 4 components) |
47% |
30% |
Family Podiatry Center will ask you to return to
the office for a follow up visit, probably at about 6 or 8 weeks after
your OssaTron treatment. Please check with Dr. Reid or Dr. Kosova 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, if you have any questions.
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 to if you have any questions or concerns
about ESW treatment for chronic proximal plantar fasciitis with the
OssaTron.
Sound
Therapy for Healing