title: Radiotherapy of painful heel spur with two fractionation regimens : Results of a randomized multicenter trial after 48 weeks' follow-up.
abstract: BACKGROUND
  In this randomized multicenter trial, we compared the effect of a lower single dose of 0.5 Gy vs. a standard single dose of 1 Gy concerning pain relief and quality of life, while maintaining a uniform total dose of 6 Gy. On the basis of laboratory observations, the lower single dose would be expected to be more effective.
  
  
  METHODS
  A total 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 a week, while the experimental group was treated with single fractions of 12 × 0.5 Gy three times a week. Patients who did not show satisfactory pain relief after 12 weeks 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 48 weeks.
  
  
  RESULTS
  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 a significant benefit concerning pain relief. Their total outcome was comparable to patients showing a good response from the beginning. No relevant acute or chronic side effects were recorded.
  
  
  CONCLUSIONS
  Both patient groups showed good results concerning pain relief. A fractionation 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.
authors.affiliation: Department of Radiotherapy and Radiooncology, Saarland University Hospital, Kirrberger Str. 1, 66421, Homburg, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Prokein
authors.affiliation: Department of Radiotherapy and Radiooncology, Saarland University Hospital, Kirrberger Str. 1, 66421, Homburg, Germany.|Department of Oral and Maxillofacial Surgery, University Hospital of Düsseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
authors.forename: Henrik
authors.initials: H
authors.lastname: Holtmann
authors.affiliation: Department of Radiotherapy, University Hospital of Regensburg, Franz-Josef-Strauß-Allee 1, 93053, Regensburg, Germany.
authors.forename: Matthias G
authors.initials: MG
authors.lastname: Hautmann
authors.affiliation: Department of Radiooncology and Radiotherapy, University Hospital of Mainz, Langenbeckstr. 1, 55131, Mainz, Germany.
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Rösler
authors.affiliation: Institute of Medical Biometrics, Epidemiology and Medical Informatics, Saarland University Hospital, Kirrberger Str.1, 66421, Homburg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Graeber
authors.affiliation: Department of Radiotherapy and Radiooncology, Saarland University Hospital, Kirrberger Str. 1, 66421, Homburg, Germany.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Dzierma
authors.affiliation: Department of Radiotherapy and Radiooncology, Saarland University Hospital, Kirrberger Str. 1, 66421, Homburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Ruebe
authors.affiliation: Department of Radiotherapy and Radiooncology, Saarland University Hospital, Kirrberger Str. 1, 66421, Homburg, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Fleckenstein
authors.affiliation: Department of Radiotherapy and Radiooncology, Saarland University Hospital, Kirrberger Str. 1, 66421, Homburg, Germany. marcus.niewald@uks.eu.
authors.forename: Marcus
authors.identifier: http://orcid.org/0000-0001-6266-0993
authors.initials: M
authors.lastname: Niewald
mesh_terms: D000328:Adult; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D036982:Heel Spur / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000523:psychology / Q000532:radiotherapy*; D010147:Pain Measurement / Q000528:radiation effects; D010315:Particle Accelerators; D011788:Quality of Life / Q000523:psychology; D011879:Radiotherapy Dosage
keywords: Analgesia; Calcaneal spur; Pain; Quality of life; Radiotherapy