A shock wave is the resultant acoustic energy wave of an explosion. For kidney stones, the shock wave must be focused to specifically apply the energy wave to the desired area as well as in the foot.
ESWT offers improvement in pain relief of Plantar Fasciitis (inflammation of the plantar fascia) and functional restoration with negligible (few) complications. It is a safe procedure and has lack of risks and complications. The cost is very expensive and the cost of ESWT is not covered by all insurances and the patient is forced to pay out of pocket. The procedure can cause micro-fractures of the calcaneus (heel bone). Also, some patients require several treatments.
Indications for ESWT include plantar fasciitis, chronic heel pain, avascular degeneration, and where conservative treatment has not prevailed and the condition still persists.
The OSSATRON is indicated for use in patients with chronic proximal plantar fasciitis who have failed to respond to conservative treatment such as physical therapy and stretching exercises, orthotics, night splints, NSAIDS, (non-steroidal anti-inflammatory drugs), cortisone injections, or previous surgery.
Because the OSSATRON has not been tested on subjects with the following conditions, it's safety and effectiveness is unknown: diabetic neuropathy, ankle or foot fracture, Peripheral Vascular Disease (poor circulation), skeletally immature patients, pregnancy, severe osteoarthritis, rheumatoid arthritis, osteoporosis, metabolic disorders, osteomyelitis (bone infection), and systemic infection.
There are no known contraindications to ESWT with the OSSATRON for treatment of chronic proximal plantar fasciitis.
Patients with bleeding disorders that may prolong clotting time may be at risk for bleeding following OSSATRON. Anesthesia should be administered prior to the procedure.
Between April 1998 and November 1999, 302 patients were treated for chronic proximal plantar fasciitis using OSSATRON ESWT. 260 received active or placebo. 42 were not randomized. Pain scale was 5-10 with10 being severe. Evaluations were obtained at 4, 8, 12 weeks post-treatment.
234 randomized patients showed a statistically significant difference in treatment versus placebo groups. Following one OSSATRON ESWT, 62% of patients met with success. 76% of all patients who received treatment, had acceptable results after 1 treatment and no longer required long term treatment or surgery. 38 complications were reported of 302 subjects.
The patient should be instructed to discontinue any medication containing aspirin or an NSAID for 3 days prior to ESWT to minimize bleeding. Patient should bring running shoes to wear home as weight bearing is allowed after the procedure. ESWT should be performed with anesthesia local or regional since the procedure is painful. Position the OSSATRON perpendicular to the patient table with the therapy arm in the horizontal position, and the coupling membrane near the plantar surface of the affected foot. The head may be placed in the vertical position, coupling membrane up, for the affected side aligned with the membrane. A total of 1500 shocks are delivered for effective treatment of chronic heel pain syndrome. Total OSSATRON treatment time is 13-15 minutes for delivery of 1500 shocks at 2.0 Hz. Upon discharge, patients are advised not to participate in stressful activity for the affected heel for 4 weeks. Orthotics are encouraged.
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 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 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 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 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 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 the hospital or surgery center a few hours before your ESW treatment is scheduled. You should wear shorts or lose 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 also will make sure you have signed a consent form for the ESW treatment.
The ESW treatment my 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.
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 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 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 the heel pain.
Percentage of Patients with Successful Outcome at 12 Weeks
| RESULTS AT 12 WEEKS | ||
|---|---|---|
| Measurement | OssaTron Treatment (n=119) |
Placebo Treatment (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 four components) | 47% | 30% |
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 your 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 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)
Apply Biofreeze during the day to cool those hot, inflamed and swollen bones & joints.
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.
If you are experiencing any of the symptoms addressed, we strongly recommend that you seek the advice of your podiatrist for proper diagnosis.