By Coriene E. Hannapel
Special to DG News

DALLAS, TX -- February 18, 2002 -- High-energy extra-corporeal shockwave therapy (ESWT) is a safe and effective modality for alleviating pain and improving the function and activity level of patients with chronic refractory proximal plantar fasciitis, according to a poster presentation at the 69^th Annual Meeting of the American Academy of Orthopedic Surgeons.

Researchers in the Division of Sports Medicine, Montefiore Medical Center at the Albert Einstein College of Medicine, Bronx, New York conducted this randomized, prospective, double-blind placebo-controlled study to evaluate the safety of ESWT for treatment of proximal plantar fasciitis unresponsive to other non-operative treatment modalities, as part of a phase I FDA clinical trial. In addition, the study evaluated the efficacy of ESWT in treating the disorder.

The study group included 47 patients who ranged in age from 26 to 60 years. Patients had to meet the inclusion criteria of evidence of proximal plantar fasciitis by history and physical exam, pain with the first step in the morning, tenderness localized to the origin of the plantar fascia of the medial tubercle of the calcaneus, and unsuccessful non-operative treatment for a period of six months.

Exclusion criteria included dysfunction of the knee or ankle, general polyarthritis, rheumatoid arthritis, ankylosing spondylitis, neurological abnormalities, nerve entrapment syndrome, and age under 18 years.

Pre- and post-treatment physical exams and questionnaires were given to all participants. Treatments were administered with the Orthowave device, which is FDA approved for investigational applications only, after injection of a local analgesic at the medial calcaneal tubercle.

Patients were randomized to two treatment groups for actual or placebo treatment and treated with two sessions at two-week intervals. Each treatment consisted of 800 impulses of high-energy acoustic shock waves. Follow-ups were done at 6, 12, and 24 weeks after the last treatment, and all patients were placed on the standardized home therapy program and nonsteroidal anti-inflammatory medication.

Patient logs were maintained for daily assessment of pain and medication use.

Results demonstrated that there was a significant alleviation of pain to palpation, improvement of function and activity and patient assessment of pain in all treated patients at all follow-up visits.

Improvement of pain over baseline was 53 percent at 6 weeks, 74 percent at 12 weeks, and 74 percent at 24 weeks. Researchers indicated that the placebo effect accounted for an average of 3 percent improvement of symptoms over baseline at 6 weeks, 14 percent at 12 weeks, and 11 percent at 24 weeks.