Study supports custom device use
By Barbara Boughton
In patients with plantar fasciitis, the pain relief associated with custom foot orthoses (CFOs) appears to result in increased walking activity, as well, according to a recently published clinical trial.
In the double-blinded randomized placebo-controlled trial, epublished in May by the Journal of the American Podiatric Medical Association, episodes of walking lasted significantly longer in patients who wore CFOs for three months than those who wore prefabricated foot orthoses (PFOs) or sham orthoses.
Study investigators randomized 77 patients who had plantar heel pain for less than a year into three treatment groups and assessed pain and function at baseline, one month, and three months. In a subset of 30 patients—10 per group—the assessed activity, balance, and gait.
At three months, patients who wore CFOs increased the duration of their walking episodes by 125% compared with baseline, while PFOs were associated with an increase of 22% and sham orthoses with an increase of just .2%. Patients who wore CFOs also outperformed the other two groups for duration of postural transitions at three months.
“The findings were an eye opener for us,” said lead researcher James Wrobel, DPM, associate professor of internal medicine at the University of Michigan in Ann Arbor. “People who wore the custom foot orthoses were getting up and out of their chairs without the presence or prompting of a physical therapist.”
Yet, improvement in self-reported morning pain and quality of life did not differ significantly between groups, suggesting that walking activity may be a more sensitive measure of the benefits of CFOs, Wrobel noted. The CFO and PFO groups also reported improvements in evening pain.
“They were obviously feeling better—but these improvements in symptoms may have been too subtle to be picked up by the scales used in the study,” Wrobel said.
All patients were given the same athletic shoes and instructed to wear them throughout the day. Every patient received longitudinal and metatarsal padding to wear for one to two weeks before the orthoses arrived, and were told to ice and stretch regularly for three months. The fact that even the sham group experienced symptom improvement at three months suggests a potential benefit of athletic shoe use, stretching, ice, and the short-term use of padding—another unique finding of the study, Wrobel noted.
At three months, those in the CFO group were stretching significantly less than at baseline and compared with the other two groups, which could be an indication of symptom relief, Wrobel noted.
The study was specifically designed to address the limitations of previous randomized trials comparing CFOs and PFOs—including the lack of a sham or placebo group and a failure to use validated health measures, Wrobel noted. The researchers also strove to make the orthoses look as similar as possible.
The CFO was a full-length cast-based polypropylene orthosis modified to address deformity, patient weight, foot and ankle function, and foot type. The PFO was a full-length ethylene vinyl acetate (EVA) orthosis with a triplanar orthotic foot bed and a 15-mm heel cup. The sham device was a full-length 3-mm thick layer of EVA that was heated and then vacuum pressed onto a positive mold of the patient’s foot. All devices had similar 3-mm neoprene top covers.
“The study is a milestone in assessing the benefits of custom and prefabricated foot orthoses for plantar fasciitis heel pain,” said Russell Volpe, DPM, professor in the department of pediatrics and orthopedics at the New York College of Podiatric Medicine/Foot Center of New York in New York City.
Volpe commended the study authors for their use of validated measures for pain and foot-related symptoms (primarily the Revised Foot Function Index and the 36-item Short Form Health Survey), and for including details of patients’ biomechanical examinations and the orthotic prescription process. Perhaps most important was the considerable effort made to measure changes in patient function, he said.
“That’s the real breakthrough in this study. The researchers showed custom foot orthoses can help patients be more active and participate more fully in activities of daily living,” Volpe said.
He also pointed out the value of the study’s finding regarding the benefit of using icing, stretching, and foot pads together.
“It reminds us that it’s important to treat plantar fasciitis with a multidisciplinary approach,” Volpe added.
Barbara Boughton is a freelance writer based in the San Francisco Bay Area.
Wrobel JS, Fleischer A, Crews RT, et al. A randomized controlled trial of custom foot orthoses for the treatment of plantar heel pain: A return to spontaneous physical activity. J Am Podiatr Med Assoc 2015 May 5. [Epub ahead of print]