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Study: Custom Orthotics Not Necessarily Better Than Prefab

By Brian McCurdy, Associate Editor
February 2005

   Many podiatrists report positive benefits anecdotally of using custom orthotics to treat plantar fasciitis. However, a recent study published in the Journal of the American Podiatric Association (JAPMA) points out flaws in the current literature on the subject and suggests there is no current evidence basis to support the notion of custom orthotics being more effective than prefabricated orthotics for plantar fasciitis.    While authors of the study concede that the “vast majority” of articles in the last 30 years say orthoses are “highly effective” in reducing plantar fasciitis symptoms, they cite a “lack of scientific evidence … to fully inform clinical practice” on using orthotics for plantar fasciitis.    While patients in previous studies reported symptom relief, authors of the JAPMA study say earlier studies are flawed due to:    • a lack of using other treatments as controls for comparison;    • patient satisfaction measures that may have been more reflective of quality service than treatment outcomes; and    • the possibility of symptom resolution being due to limiting certain activities.    While they believe foot orthoses do have a role in managing plantar fasciitis, the authors of the study say the lack of sufficient evidence prevents any kind of determination on whether customized orthoses are more effective than prefabricated devices. They emphasize the need for more randomized controlled trials on this subject.

Assessing The Value Of The Study

   Paul Scherer, DPM, disagrees with the authors’ assertion that only randomized controlled trials, and not outcome studies, can demonstrate effectiveness. He is not aware of an outcome study only for prefab orthotics. However, Dr. Scherer does agree with the study’s lead author Karl B. Landorf, DipAppSc (Pod), that several of the studies mentioned on this subject are “flawed in either the methods or statistical methods.”    He cites an article by Pfeffer, et. al., which attempts to compare functional orthoses with stretching and pads. According to Dr. Scherer, the study used several inexperienced technicians who viewed a instructional videotape on casting prior to casting for the custom orthoses.     “This is comparable to several different chemists making COX-2 inhibitors for the first time to evaluate the effectiveness of the drug,” argues Dr. Scherer, Chairman of the Department of Applied Biomechanics at the California School of Podiatric Medicine at Samuel Merritt College.    Douglas Richie Jr., DPM, agrees that the profession needs more randomized, controlled trials to determine the efficacy of custom versus prefabricated orthoses in treating plantar fasciitis. He says the JAPMA article “does an excellent job” critiquing the existing research and enumerating the “many shortcomings” of published studies.     “The current article points out there is simply not enough published evidence demonstrating the superiority of custom orthoses over prefabs,” asserts Dr. Richie, the President of the American Academy of Podiatric Sports Medicine. “This is not to say that custom orthoses are not superior, only that they have not been tested adequately according to acceptable scientific methodology.”

Emphasizing The Strengths And Appropriate Use Of Custom Orthoses

   Several leading DPMs cite the advantages of custom orthotics.     “The authors’ assertion that a custom device is not more effective than a prefab device is difficult to understand,” says Eric Feit, DPM, a Fellow of the American College of Foot and Ankle Surgeons. “Custom orthotics are often the primary reason a patient is able to avoid surgery for plantar fasciitis.”    Dr. Scherer says custom orthotics are the most effective treatment for proximal plantar fasciitis. Citing an outcome study he published in JAPMA in 1991, Dr. Scherer says a functional device, when properly cast and fabricated, is 89 percent effective in producing more than 80 percent relief from the condition.    Dr. Feit notes a custom device is always superior to a prefab device in its fit, comfort and degree of clinical correction. Custom orthotics are advantageous in treating plantar fasciitis as they relax or support the fascia with weightbearing, which minimizes tension on the calcaneal insertion and allows micro-tears to heal, according to Dr. Feit.    He adds that an orthotic helps lock up the midtarsal joint and minimizes abnormal pronation, which would also stretch the fascia. With a custom device, one can prescribe specific modifications to achieve a different balance for the foot. Dr. Feit says this is a “primary advantage.” Dr. Feit notes a medial skive technique will apply pressure on the subtalar joint axis to help correct calcaneal eversion and an inverted orthotic helps apply more pressure on the talonavicular joint, which alleviates tension on the fascia.    However, as Dr. Richie warns, while DPMs have intuitively attempted to “support the medial arch,” popular orthotic strategies may actually increase strain in the plantar fascia. For example, he points out that applying a varus forefoot post actually increases strain in the plantar fascia in most foot types. According to Dr. Richie, current positive cast correction techniques, which many high-volume orthotic laboratories practice, may cause and increase strain in the plantar fascia, particularly when the orthotic foot plate is trimmed too wide.    In regard to the treatment of plantar fasciitis, Dr. Feit also cautions that a custom device may be better but is not always necessary. Many patients can alleviate pain using OTC prefab orthotics, stretching exercises and good supportive shoes, according to Dr. Feit.    That said, Dr. Feit notes that prefabricated orthotics have disadvantages in that they do not fit well for everyone and are usually designed for those with flat and flexible feet. As a result, he says an OTC device does not provide enough support for a patient with a high arched foot or a rigid foot type, and overweight patients will flatten out a prefab device and limit its effectiveness. Dr. Feit says patients with severe inflammation of the fascia in the mid-arch will not tolerate orthotics whether they are prefab or custom.    As Dr. Feit notes, custom orthotics typically last three to four years, aid in preventing recurrence of the injury and also help resolve the symptoms. In contrast, he says prefab orthotics last three to six months for an active patient and do not provide adequate support in more than half of patients with heel and arch pain.

Does Anecdotal Evidence Make The Case For Custom Orthotics?

   In his 23 years of experience, Dr. Richie has found custom functional foot orthoses are “far superior in effectiveness” than prefabricated devices in treating plantar heel pain. Dr. Scherer also believes anecdotal evidence is obvious in demonstrating effectiveness of the treatment. “I believe that custom orthoses are more effective than prefabricated (devices) but I also agree that there is no hard evidence to this effect,” he asserts.    Should a scarcity of scientific evidence deter DPMs from using customized orthoses? “Just because the literature has not yet validated this anecdotal evidence, we need not abandon current treatment protocols which are working well in clinical practice,” says Dr. Richie, an Adjunct Clinical Professor of Biomechanics at the California School of Podiatric Medicine at Samuel Merritt College.    Despite the successes of those using custom orthotics, Dr. Scherer believes there are still other questions to be considered regarding treating plantar fasciitis. He notes it is not known how either custom or prefab orthotics affect the pathomechanics of plantar fasciitis. Dr. Scherer believes the profession should question which mechanical change in the foot produces plantar fasciitis before trying to determine which of the 10 mechanical therapies in the literature is more effective.     “It seems to me that the financial motivation to focus on the devices is overshadowing the academic pursuit of the cause of the pathology,” says Dr. Scherer.

Conference Emphasizes Multidisciplinary Care To Prevent Amputations

By Brian McCurdy, Associate Editor    When facing possible amputation, patients with diabetes require the expertise of podiatrists as well as physicians in a variety of fields. With this in mind, specialists from eight disciplines will gather for a unique session next month on amputation prevention in this high-risk population.    As part of the Diabetic Foot Global Conference (DFCON 05) meeting, which takes place March 3 to 5 in Los Angeles, eight specialists will take part in “Interdisciplinary Approach to Amputation: Toes, Team and Turf,” which will be moderated by George Andros, MD, and David G. Armstrong, DPM, MSc, PhD. The panelists are endocrinologist Peter Sheehan, MD, podiatrist Lawrence Harkless, DPM, vascular surgeon Gary Gibbons, MD, orthopedist Charles Saltzman, MD, nurse Susie Seaman, MSN, NP, infectious disease specialist Benjamin Lipsky, MD, physical therapist Michael Mueller, PT, and plastic surgeon Christopher E. Attinger, MD.     “This meeting will be like no other meeting because it brings together unquestionably the most international gathering of top experts in the world in this field,” says Dr. Armstrong, a National Board Member of the American Diabetes Association. “It will be the most significant meeting on the subject in 2005.”    What lessons can the podiatric profession provide to other specialists dealing with foot amputation? Dr. Armstrong asserts that the podiatrist is the “point guard” on the diabetic foot team. Dr. Armstrong notes the DFCON 05 meeting will demonstrate that podiatrists who treat diabetic foot interact well with those in other professions given the crossover between disciplines.    When it comes to treating the diabetic foot, “no clinician is an island unto himself,” says Dr. Armstrong, a Professor of Surgery, Chair of Research and Assistant Dean at the Dr. William A. Scholl College of Podiatric Medicine at the Rosalind Franklin University of Medicine. Whether the leader of the diabetic foot team is a podiatrist, a vascular surgeon, an endocrinologist or another physician, Dr. Armstrong says he or she must be passionate about prevention. For more information on DFCON 05, go to www.dfcon.com.

Temple Focuses On ‘Dying Art’ Of Biomechanics And Gait Analysis

By Brian McCurdy, Associate Editor    While students at the Temple University School of Podiatric Medicine in Philadelphia receive an education in a broad range of areas, the study of biomechanical and gait-related pathologies is a particular point of emphasis in the school’s Department of Podiatric Orthopedics and Biomechanics.    John H. Walter, DPM, MS, the Chairman of the aforementioned department, says the study of biomechanics and gait is a “dying art” as it is not emphasized enough in podiatric residencies.     “They now go anywhere from a two to four-year residency without completing a biomechanical exam or gait analysis after graduation,” states Dr. Walter. “This can cause them to lose many of the valuable skills they learned in school.”    The school continues to have the one of the most sophisticated and advanced centers for the study of biomechanics and locomotion, according to Dr. Walter. To that end, Temple utilizes the F-Scan System and the Footmaxx System, which help students analyze gait and enhance their problem-solving skills in gait analysis situations.    The school also offers instruction in physical therapy, casting and orthotics. Other courses range from clinical orthopedics and traumatology to pediatrics and sports medicine. Dr. Walter says the school also offers a general orthopedics rotation at hospitals.    The school also offers hands-on instruction with pedorthists. One pedorthist at Temple teaches students about prescribing shoe gear, measuring feet and making custom-molded shoes. Another pedorthist at the school casts patients for various types of bracing and prosthetics.     “This is extremely instrumental and beneficial to students as this gives them some background and hands-on experience with the fabrication and construction of various types of shoes and bracing,” says Dr. Walter, a Diplomate of the American Board of Podiatric Surgery and a Fellow of the American College of Foot and Ankle Orthopedics and Medicine.    Dr. Walter says students also receive hands-on experience in Temple’s orthotic lab, where they can learn to fabricate orthotics. Students make one pair of orthotics for themselves and an instructor makes another pair in his own lab through a laser scanning technique. Dr. Walter says this gives students a background in the making and wearing of orthotics as well as prescribing orthotics to patients.

What Will The Future Bring?

   The podiatric orthopedic program also makes efficient use of technology, which will figure in several of the school’s future endeavors. Dr. Walter says several faculty members have produced online lectures that are available for outside practitioners. Later this year, Dr. Walter and Larry Goss, DPM, will produce a traumatology CD and a Palm Pilot edition that will cover in-depth traumatology to soft tissue and bone of the lower extremity.    In the future, Dr. Walter says the Temple program hopes to develop additional outside externship rotations in pediatrics and traumatology. He adds that negotiations are currently underway with a physical therapy company to combine resources at the school to expand the patient base and enhance the experience of students in caring for patients with all forms and types of therapy needs.

In Brief

   Podiatric experts will converge on Chicago in April for the Midwest Podiatry Conference. The meeting offers an array of tracks ranging from pediatrics, and peripheral vascular disease to rearfoot deformities and Charcot reconstruction.    The Midwest Podiatry Conference also offers a Surgical Board Review and emerging research from the National Post-Graduate Research Symposium.    The conference also will include a wound care track. Among the issues discussed will be enzymatic agents in wound care and an intriguing look at a study that compares Apligraf (Organogenesis) and the Graftjacket (Wright Medical) after 12 weeks of treatment. The Midwest Podiatry Conference will be April 7 to 10 at the Chicago Hilton in Chicago, Ill. For more information, go to www.midwestpodconf.org.

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