FOOT AND ANKLE
ORTHOPEDICS TODAY July 1, 2010
Shock wave therapy effective for chronic heel pain in randomized, prospective trial
Visual Analog Scale pain scores at 12 months post-treatment dropped 7.5 points from baseline and those patients reported no major adverse events.
Investigators for a multicenter study found that extracorporeal shock wave therapy safely and effectively reduced recalcitrant chronic plantar heel pain, according to findings from their randomized placebo-controlled trial.
“The focused extracorporeal shock wave therapy (ESWT) 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, said 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 data he presented have been submitted to the U.S. Food and Drug Administration for possible clearance of the Duolith SD1 (Storz Medical) used in the study for this indication.
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 0.25 mJ/mm2 ESWT, 4 Hz frequency, 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 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
* Gerdesmeyer L, Gollwitzer HW, Saxena A, et al. Focused shock wave therapy in chronic plantar heel pain: A randomized placebo controlled trial. #706. Presented at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons. March 9-13, 2010. New Orleans.
Ludger Gerdesmeyer, MD, can be reached in the Department of Orthopedics and Traumatology, Klinikum Recht der Isar, Technical University Munich, Insmaniger Str. 22, Munich, Germany; 49-89-41402271; e-mail: email@example.com.
Carol C. Frey, MD
Carol C. Frey
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
Foot & Ankle Section Editor