Cath Lab Digest

   ESWT has emerged as a noninvasive, minimal risk procedure for chronic conditions such as plantar fasciitis. ESWT allows patients to return to activities of daily life within one or two days with immediate return to most jobs and normal daily shoegear. Complications of ESWT for plantar fasciitis have been virtually non-existent.

   In 2002, we published a paper in JFAS showing 82 percent success with ESWT. This success rate was comparable to our success rate with the minimally invasive plantar fasciotomy (83 percent), which we published in JFAS in 1994. This pilot study was a retrospective study and we are certainly aware that only a randomized, prospective, placebo-controlled study can provide evidenced based medicine.

   However, this is true of all the studies on surgical outcomes for plantar fasciitis as these studies are similarly designed as retrospective without the control of a placebo group. Therefore, our study shows that outcomes with ESWT are comparable to surgical outcomes without the risks, complications and disability inherent to surgery.

   Without a doubt, the literature is controversial when it comes to the relative benefit of ESWT. Opponents of ESWT point to literature that shows its ineffectiveness when it is compared to placebo. One can selectively quote literature to support a stance on ESWT either way.

   However, some of the oft-discussed papers against ESWT have been scientifically flawed. The paper most often cited by the opponents of ESWT is by Buchbinder out of Australia. This study included patients who had heel pain for as little as six weeks and ESWT energy levels were given to each patient’s tolerance rather than having a uniform standard application throughout the study. Furthermore, the energy levels used were far less than those recommended in the U.S.

   Additionally, the placebo group was administered a small dose of ESWT that could have theoretically been therapeutic. Lastly, the study was performed by a non-clinician who worked for the government of a national health care system. The motives of the study were skewed from the beginning.

   Critics will also point out that ESWT is extremely expensive. However, the cost of new technologies is often high as it is with new pharmaceuticals. The benefits of ESWT in terms of social costs are immeasurable. Patients are able to return to activities of daily life and work immediately. There are no costs of lost work to either the patient or employer. There are virtually no risks or complications with ESWT whereas postoperative nerve injuries and infections can require intense medical care that can run into tens of thousands of dollars. These are just some of the examples of the overall cost benefit of ESWT over surgical options.

What Studies Say About Electrohydraulic, Piezoelectric And Radial Devices

   Over the past two years, the Weil Foot and Ankle Institute has been fortunate to be involved with five different randomized, double-blind, placebo-controlled studies on the effectiveness of shockwave. Three of the studies were multicenter, pivotal studies for the purpose of securing a PMA from the FDA. The other two were single site studies.

   Two of the multicenter FDA studies utilized sedation. One study involved the electrohydraulic device whereas the other study involved the piezoelectric device. Both studies had a rigorous exclusion criteria with qualified patients having pain for greater than six months and medical treatment for at least four months that included at least four of the following: arch support (custom or OTC), antiinflammatory medication for at least four weeks, cortisone injection, physical therapy, night splints, stretching exercises and/or shoe modifications.

   Patients were given sedation and the appropriate heel was anesthetized with 6 to 10 cc of 0.5% Marcaine plain. Computer randomization then determined whether the patient would receive active treatment or a sham treatment (no treatment). These patients were then followed for three months by a podiatric physician, who was not aware of the treatment that was provided to these patients.