Investigators for a multicenter study found that extracorporeal shock
wave therapy (ESWT) both safely and effectively reduced recalcitrant chronic
plantar heel pain, according to findings from their randomized placebo-
controlled trial.
“The focused extracorporeal shock wave therapy as applied in this
study shows statistically and clinically relevant results with a much better
outcome in the active group,” compared to the control group, Ludger
Gerdesmeyer, MD, of Kiel, Germany, explained at the 2010 Annual Meeting of the
American Academy of Orthopaedic Surgeons in New Orleans.
In the ESWT study group, “We have found no relevant side
effects,” Gerdesmeyer said.
The 250-patient study was conducted at European and U.S. centers.
Investigators enrolled patients from each center with chronic plantar heel pain
of greater than 5 on the Visual Analog Scale (VAS) that did not respond to
conservative care.
After a wash-out period, patients were randomized to either the active
or control group. The active group received ESWT with the device focused on the
site of heel pain without the aid of any radiography. Patients in the control
group underwent a sham treatment where the ESWT device was deactivated but used
identically.
Patients underwent three treatments each. Their results were assessed at
3 months and 12 months following their last treatment using the VAS pain scores
as the main outcome measure. Results of the Roles and Maudsley patient
self-assessment score and the SF-36 score served as secondary outcomes.
At 3 months, baseline composite VAS scores of 8.3 points decreased to
2.7 points after ESWT in the active group and decreased to 5.3 points in the
control group. In the ESWT group, VAS scores further decreased after 12 months
to 0.8 points.
“In the active group we have 69% of the patients [having] more than
60% pain reduction compared to baseline,” Gerdesmeyer said. By comparison,
sham treatment was associated with more than 60% pain reduction in 34% of
control patients, he said.
Differences between the baseline and follow-up secondary outcomes also
favored the active group.
No major adverse events occurred related to ESWT treatment. Some
patients treated with ESWT, however, reported device-related events including
slight pain or discomfort during and after treatment and minor local swelling
or redness.
“It was interesting to see that placebo patients getting just a
sham treatment also reported pain during treatment,” Gerdesmeyer added.
— by Susan M. Rapp
For more information:
- Gerdesmeyer L, Gollwitzer HW, Saxena A, et al. Focused shock wave
therapy in chronic plantar heel pain: A randomized placebo controlled trial.
Paper #706. Presented at the 2010 Annual Meeting of the American Academy of
Orthopaedic Surgeons. March 9-13, 2010. New Orleans.
Published studies report that more than 2 million patients are treated
for plantar fasciitis each year, accounting for approximately 11% to 15% of all
foot-related encounters with physicians annually. Plantar fasciitis is a
painful inflammatory process that when not treated can evolve into chronic
degenerative changes in the fascia. Traditional treatment options, including
conservative measures and medication, have shown success rates from 44% to 82%.
Surgical intervention with open or endoscopic release of the plantar fascia has
unpredictable results, substantial risks and recovery is usually very slow
— 1 year. Researchers have been building a strong body of published
clinical evidence for ESWT. ESWT has been shown to be safe and effective in
several prospective randomized studies including studies by Gerdesmeyer. In
cases of failed nonsurgical treatment, ESWT represents an excellent option to
surgery and radial ESWT may be a better option than focused ESWT, as anesthesia
is not required.
— Carol C. Frey, MD
Director, orthopedic
foot and ankle surgery, West Coast Center for Orthopedic Surgery and Sports
Medicine, and clinical assistant professor of orthopedic surgery, UCLA
