Shockwave Therapy Effective for Treating Heel Pain

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.
Focused ESWT

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.
Less pain

“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

Reference:

* 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: gerdesmeyer@aol.com.

Perspective

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
Orthopedics Today

Foot Woes Keeping Him on His Toes

Podiatrist Lowell Weil Sr. had to travel to Papua New Guinea to find people without any foot problems.

"I went there to look at their feet because there'd been a paper written that showed that none of them had bunions. In fact, they have big toes that go out in the other direction," he said, noting the natives never wore shoes. "I had to see it for myself and I did. I took hundreds of pictures of the natives sticking their feet out."

Dr. Lowell Weil Sr. in an office at the Weil Foot and Ankle Institute in Des Plaines. Weil is a long-time Glenview resident and is known as the pioneer of shockwave treatment for heel pain.
(Allison Williams/Staff Photographer)

That solidified for Weil that shoes are a big culprit in aggravating bunions, although not necessarily causing them.

Weil, medical director of the Weil Foot and Ankle Institute in Des Plaines, has seen a lot of bunions, flat feet and other painful conditions below the ankle in 45 years of practice.

His specialty is the front part of the foot, where he designed an operation to shorten a bone causing pain under the ball of the foot that a French orthopedic surgeon named for him.

"I was in France lecturing. Somebody asked me from the audience, 'What do you do for this condition?' and there was a blackboard back in those days and I drew a picture. The next thing I knew, I came back to America and a friend of mine, an orthopedic surgeon, said to me, 'What the hell is this Weil osteotomy?'"

Most recently, he and his son, Lowell Weil Jr. of Lake Forest, who's part of the practice, lectured to a Chicago audience about the results of a nine-year study that showed sonic shockwave therapy has been effective in treating plantar fasciitis, a common form of heel pain.

Weil Sr. is also an expert in the "Refrigerator stepped on me" condition -- a reference to the jokes he heard from teammates of former Chicago Bear William "Refrigerator" Perry during the 25 years he spent as the football team's podiatrist.

Weil grew up in Skokie, where his parents long ran Weil Women's Clothing in downtown Skokie.

He settled with his wife, Nancy, in Glenview 37 years ago, in a house once owned by former Illinois Governor Otto Kerner.

Weil served on the Glenview Village Board from 1986 to 1990. His wife was on the Glenview School District 34 Board from 1980 to 1987.

Now a grandparent of six, Weil balances work with time at their second home in Mexico and travel.

"It's fun to be able to help people and meet the kind of people we meet," he said. "I never thought I'd be able to lecture in 29 countries and travel everywhere. I thought I'd have a nice little practice in Des Plaines, Ill. but it turned into something more than that."

-- Lynne Stiefel

Originally published August 10, 2010 in Glenview Announcements