Saturday, March 18, 2000
Following positive results from the application of extracorporeal shock wave therapy in Europe for the treatment of chronic heel pain and plantar fasciitis, an FDA-approved study of electrohydraulically generated shock waves has been instituted, said John A. Ogden, MD, director of orthopaedics, Atlanta Medical Center, Atlanta, Ga. "This method is directed at the application of shock waves to the region of chronic pain adjacent and distal to the insertion of the plantar fascia onto the inferior calcaneus," Dr. Ogden said.
Treatment was given to 147 patients enrolled on the basis of specific exclusion/inclusion criteria. Symptoms had been present for an average of 142 weeks, with a max-imum of nine years. Thirty-one patients were non-randomized during the training period for the investigatory centers, following which 116 patients have been randomized to actual or placebo treatment. Patients were given 1,500 shocks at 18 kV following an ankle block. Patients have been evaluated at four-, eight- and 12-week intervals, and also are being followed six and 12 months post-treatment. Patients were graded according to four criteria, all of which had to be "passed" to be graded a success.
Patients known to have received treatment scored 74 percent for all four success-criteria. In contrast, 45.8 percent of the randomized patients met similar success criteria. However, the double-blind was not broken at this stage unless the patient chose to quit the study and reenroll. One known placebo patient showed improvement, while all other known placebo patients have chosen to receive the actual treatment and are under current evaluation.
It is anticipated that 250 patients will be enrolled and that double-blind data will have been completely analyzed at the time of presentation.
Other investigators participating in the study are Richard G. Alvarez, MD, Memorial Hospital, Chattanooga, Tenn.; G. Lee Cross, MD, Atlanta Medical Center, Atlanta, Ga.; and Richard L. Levitt, MD, HealthSouth Doctors Hospital, Coral Gables, Fla.
|2000 Academy News March 18 Index B|
Last modified 18/March/2000 by IS