Radiotherapy of painful heel spur with two fractionation regimens : Results of arandomized multicenter trial after 48weeks' follow-up.

Abstract

In this randomized multicenter trial, we compared the effect of alower single dose of 0.5 Gy vs. astandard single dose of 1 Gy concerning pain relief and quality of life, while maintaining auniform total dose of 6 Gy. On the basis of laboratory observations, the lower single dose would be expected to be more effective. Atotal of 127 patients suffering from painful heel spur were randomized: Patients in the standard group were treated with single fractions of 6× 1 Gy twice aweek, while the experimental group was treated with single fractions of 12× 0.5 Gy three times aweek. Patients who did not show satisfactory pain relief after 12weeks were offered re-irradiation with the standard dose. The study's primary endpoints were pain relief and quality of life. Therapy results were evaluated and compared based on follow-up examinations after 12 and 48weeks. The data of 117 patients could be evaluated. There was no significant difference between the groups concerning the results of a visual analogue scale (VAS), Calcaneodynia Score (CS), and the somatic scale of the 12-Item Short-Form Health Survey(SF-12). Patients undergoing re-irradiation showed asignificant benefit concerning pain relief. Their total outcome was comparable to patients showing agood response from the beginning. No relevant acute or chronic side effects were recorded. Both patient groups showed good results concerning pain relief. Afractionation schedule of 12× 0.5 Gy was not superior to the current standard dose of 6× 1 Gy. Further trials are necessary to explore the best fractionation schedule.