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Therapies - Extracorporeal Shock Wave

Using the Dornier Epos Ultra
Extra-corporeal Shock Wave Therapy (ESWT) is a non-surgical alternative for the treatment of foot pain associated with plantar fasciitis. Shock wave therapy has been used since the early 1980's for the treatment/break-up of kidney stones. The application of shock wave therapy to soft tissue body parts was pioneered in Europe in the 1990's and has recently begun receiving FDA approval in the USA.
In shock wave therapy, a shock wave device generates a single pulse acoustic (shock) wave. Current techniques for generating shock waves include electromagnetic, electrohydraulic, and piezoelectric.

The shock wave propagates rapidly in a 3-D space through a fluid medium. Ultrasound coupling gel is used to facilitate transmission to the tissue. The generation of the shock wave causes a sudden rise in pressure at the wave front. The energy within the shock wave is dissipated at the interface of substances with differing acoustic impedance. In ESWT, shock waves are rapidly generated and focused using a lens. Cavitation, the formation and movement of small bubbles in a fluid, is the result of the shock wave. ESWT causes mechanical tissue disruption and is theorized to result in neovascularization in the treatment area.
The frequency of plantar fasciitis is equal between males and females. Approximately 70-90% of heel pain can be managed with non-operative measures.

Current conservative treatments for plantar fasciitis include:
  • Rest
  • Physical Therapy
  • Heel Cushions
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Corticosteroid injections
  • Taping
  • Orthotics
  • Shoe Modifications
  • Nightsplinting
  • Casting

  • ESWT is an alternative to surgery. It is recommended that individuals meet the following criteria:
  • Greater that 18 years old.
  • Visual Analog Scale (VAS) score greater than five (5) for pain during the first few minutes of walking in the morning.
  • Six months of unsuccessful conservative therapy to include any NSAIDs and three other conservative therapies.
  • Single site tenderness with local pressure over the medial calcaneal tuberosity on passive dorsiflexion of the foot.

  • There are no known complications reported with the application of ESWT to plantar fasciitis. Adverse effects typically associated with treatment include:
  • Pain or swelling for a brief period following treatment
  • Localized numbness, tingling or decreased sensation in the foot at the site of shock wave delivery
  • Local subcutaneous hematoma, minor bruising, or petechial bleeding in the foot or at treatment site

    ESWT is NOT RECOMMENDED for individuals with documented:
  • Systemic inflammatory disease such as rheumatoid arthritis, ankylosing spondylitis, Reiter's syndrome, etc.
  • Bleeding disorder, platelet disorder or hemophilia
  • Pregnancy

    The Dornier Epos Ultra is an electromagnetic shock wave demise. Its total energy flux density can be varied to deliver from 0.03 - 0.98 mJ/mm2 per shock. The frequency of the shock waves can be varied from 60-240 shocks/minute. Configured for ESWT of the plantar fasciitis, the focal point is cylindrical in shape and is approximately 3mm in diameter x 27mm in length.

    Using the Dornier Epos Ultra, shock waves are applied to the medial aspect of the foot. The treatment protocol calls for local ankle block anesthesia. Treatment takes place in a single session. Approximately l300mJ/mm2 of energy is given over 3800 shocks. Of the 3800 shocks given, 3500 are given at "Level 7", which corresponds to a positive energy flux density of 0.36 mJ/mm2 per shock. An initial 300 shocks are given at lower energy levels to adjust the patient to the treatment. Shock wave frequency is increased from 60 to 240 shocks/minute during treatment. Total treatment time is approximately 20 minutes.

    Common causes of pain associated with ESWT treatment include:
  • Shock waves being applied too close to the calcaneous
  • Shock waves terminating on the skin of lateral aspect of the foot

    After receiving ESWT, patients can resume "near" normal activity. The foot should be iced regularly and if orthotics (or other heel cushions/shoe modifications) are currently used, continue their use as prescribed. Heavy exercise or high impact activities should be avoided for 2-3 weeks.

    In the clinical study submitted by Dornier for the FDA approval of the Epos Ultra for the treatment of plantar fasciitis, 61.6 percent of the patients receiving treatment showed good to excellent results (using the Roles & Maudsley pain score) after 3 months. In that same study, the VAS (Visual Analog Scale) pain score decreased from 7.7 to 3.4 (10-point scale). In a separate study by Weil et. al., 82% of the patients receiving treatment were satisfied or very satisfied with the ESWT treatment after an average 8.4 months.

    What Patients Should Know About ESWT

    Introduction
    Studies demonstrate that 15-20% of new patients seeking care by foot and ankle specialists complain of heel pain. Plantar fasciitis, heel spur syndrome, heel bursitis, nerve entrapment, stress fracture, gout, and systematic inflammatory conditions are just some of the possible causes. The vast majority (70-90%) if individuals diagnosed with heel spur syndrome / plantar fasciitis respond well to non-operative treatment. Until recently, the only remaining treatment option for those individuals that failed to improve was surgical intervention. Extracorporeal Shock Wave Therapy (ESWT) now offers heel pain suffers new treatment options.

    What is ESWT?
    Extra-corporeal Shock Wave Therapy is a new non-invasive alternative to surgery. Similar technology has been used to successfully treat kidney stones since the 1980's. In this new application, shock waves are applied to the foot, aimed at the inflamed plantar fascia. Shock waves cause a "microtrauma" in the treated tissue, which in turn triggers the body's own, healing mechanism. Over stimulation of the pain transmitting nerves causes the release of enzymes that reduce pain. The tissue irritation that occurs further results in the ingrowth of new blood vessels to repair and heal the chronically irritated fascia.

    What Happens During Treatment?
    The entire treatment takes approximately 30-45 minutes. Your doctor will examine your foot and you will be asked to identify the area that presents the most pain. Your doctor will then proceed to numb your foot in preparation for treatment.

    You will be asked to sit or lie on the examination table. Your doctor will apply a gel to both your foot and therapy equipment. With ultrasound imaging, your doctor will visualize and measure the inflamed plantar fascia. Your foot will then be positioned on the shock wave head for shock wave therapy. You will hear small "snaps" that pick up in frequency as treatment is given. After treatment, you will be able to walk out of the treatment room and resume normal activity. You should avoid strenuous activities for 2-3 weeks.

    Who Qualifies?
    Generally, an individual who has failed to improve after six months of conservative management would be considered a suitable candidate. This includes stretching, shoe inserts / orthotic devices, cortisone injections, non-steroidal anti-inflammatory drugs, physical therapy, night splints, CAM walkers, weight loss, and rest.

    What are the Expected Results?
    A clinical study by Well, Roukis and Well et. al., The Journal of Foot and Ankle Surgery (Volume 41, No. 2) found that at an average 8.2 months following treatment, 82% of the patients treated with ESWT were very satisfied or satisfied. This compares with 83% of patients that had undergone surgical release of the fascia.

    What about the Risks?
    Adverse effects that have been reported seem to parallel the risks associated with the infiltration of local anesthetics, such as nerve injury or irritation, hematoma, bruising, and skin rash.

    What is the Post Treatment Care?
    Patients that have undergone ESWT may return to their pre-treatment level of function immediately following the procedure. That is, providing they are wearing supportive footgear, preferably in combination with orthotic devices / shoe inserts. Application of ice for the first few days may prove helpful. One may expect an increased level of discomfort three to seven days post-treatment as the local inflammatory response ensues. Athletic and strenuous weight bearing activities should be avoided for two to three weeks.

    What are the Long Term Effects?
    Sufferers of heel pain must consider their symptoms as a condition which should be managed by continued compliance with stretching, supportive footgear and avoidance of barefoot activities as well as positions which place excessive load on the forefoot (i.e. standing on ladders, squatting, walking uphill, etc.)

    Fees/Insurance?
    Since ESWT is a new application for heel pain, some insurance companies have fee schedules which include coverage. Others have not yet developed payment guidelines. Your doctor will assist you in determining insurance coverage and your share of the financial obligation.

    Summary
    As with any treatment option there are no guarantees or assurances. No single treatment should be considered a panacea. Clinical studies have shown ESWT to be safe and effective in treating heel pain in individuals who have not responded to traditional conservative therapies such as stretching, shoe inserts / orthotic devices, cortisone injections, non-steroidal anti-inflammatory drugs, physical therapy, night splints, CAM walkers, weight loss, and rest. However, it appears that ESWT offers a clinical response similar to percutaneous plantar fascial release without the risks and loss of wages associated with surgery.

    In the study by Weil et. al., patients reported improvement on the Visual Analogue Scale from 7.9 down to 3.1 at the 3 month follow-up.

     






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