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Radiotherapy of painful heel spur with two fractionation regimens

Results of a randomized multicenter trial after 48 weeks’ follow-up

Strahlentherapie des Fersensporns mit 2 Fraktionierungsschemata

Ergebnisse einer randomisierten Multizenterstudie nach 48 Wochen Follow-up

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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.

Patients and 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.

Conclusion

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.

Zusammenfassung

Hintergrund

In dieser randomisierten Multizenterstudie wurde der Effekt einer niedrigen Einzeldosis von 0,5 Gy hinsichtlich Schmerzen und Lebensqualität mit demjenigen einer Standarddosis von 1,0 Gy verglichen, dies bei konstanter Gesamtdosis von 6 Gy. Nach Laborergebnissen war eine Überlegenheit der niedrigen Einzeldosis zu erwarten.

Patienten und Methodik

Es wurden 127 Patienten randomisiert – einerseits in die Standardgruppe mit 6 Fraktionen à 1,0 Gy 2‑mal pro Woche, andererseits in die experimentelle Gruppe mit 12 Fraktionen von 0,5 Gy 3‑mal pro Woche. Patienten mit ungenügendem Ansprechen nach 12 Wochen wurde eine zweite Strahlentherapieserie mit der Standarddosis angeboten. Die Endpunkte waren die Schmerzlinderung sowie die Besserung der Lebensqualität. Diese Parameter wurden 12 und 48 Wochen nach Strahlentherapie ausgewertet.

Ergebnisse

Die Daten von 117 Patienten waren auswertbar. Es fand sich kein signifikanter Unterschied zwischen den Gruppen hinsichtlich der Ergebnisse auf einer visuellen Analogskala (VAS), des Calcaneodynie-Scores und des somatischen Teils des SF-12-Fragebogens. Patienten mit ungenügendem Ansprechen profitierten deutlich von einer zweiten Therapieserie. Deren Ansprechen war ebenso gut wie bei Patienten, die bei der ersten Serie gut auf die Therapie angesprochen hatten. Akute und chronische Nebenwirkungen wurden nicht beobachtet.

Schlussfolgerung

Beide Patientengruppen zeigten ein gutes Ansprechen hinsichtlich Schmerzlinderung und Lebensqualität. Die Ergebnisse nach der geringeren Einzeldosis mit 12-mal 0,5 Gy waren hingegen nicht besser als diejenigen nach der Standarddosis von 6‑mal 1 Gy. Weitere Studien zur Festlegung der optimalen Einzeldosis sind notwendig.

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Authors and Affiliations

  1. Department of Radiotherapy and Radiooncology, Saarland University Hospital, Kirrberger Str. 1, 66421, Homburg, Germany

    Benjamin Prokein,  Henrik Holtmann,  Yvonne Dzierma,  Christian Ruebe,  Jochen Fleckenstein &  Marcus Niewald

  2. Department of Oral and Maxillofacial Surgery, University Hospital of Düsseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany

    Henrik Holtmann

  3. Department of Radiotherapy, University Hospital of Regensburg, Franz-Josef-Strauß-Allee 1, 93053, Regensburg, Germany

    Matthias G. Hautmann

  4. Department of Radiooncology and Radiotherapy, University Hospital of Mainz, Langenbeckstr. 1, 55131, Mainz, Germany

    Hans-Peter Rösler

  5. Institute of Medical Biometrics, Epidemiology and Medical Informatics, Saarland University Hospital, Kirrberger Str.1, 66421, Homburg, Germany

    Stefan Graeber

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  1. Benjamin Prokein
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  9. Marcus Niewald
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Corresponding author

Correspondence to Marcus Niewald.

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Conflict of interest

B. Prokein, H. Holtmann, M.G. Hautmann, H.-P. Rösler, S. Graeber, Y. Dzierma, C. Ruebe, J. Fleckenstein, and M. Niewald declare that they have no competing interests.

Ethical standards

Informed consent was obtained from all patients included in this study.The ethics committee of the Saarland Physicians’ chamber approved the study protocol (number 14/07 on 09/05/2012). Furthermore, the study was approved by the DEGRO expert comittee and is in compliance with the Declaration of Helsinki in its current version.

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Author contributions

B. Prokein wrote the manuscript, performed follow-up examinations, and was responsible for the data acquisition. M. Niewald is the principal investigator of this trial, enrolled the patients, performed follow-up examinations, supervised the data acquisition and evaluation, and corrected the manuscript. H. Holtmann performed follow-up examinations, was responsible for the data acquisition, and corrected the manuscript. M.G. Hautmann and H.-P. Rösler enrolled and treated patients in their departments, performed the follow-up examinations, and corrected the manuscript. S. Graeber was responsible for the data evaluation and statistics. Y. Dzierma was responsible for the physical plans for the patients, created the figures, and revised the manuscript. J. Fleckenstein supervised the daily radiotherapy of the patients and revised the manuscript. C. Ruebe supervised the radiotherapy and revised the manuscript. All authors read and approved the final manuscript.

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Prokein, B., Holtmann, H., Hautmann, M.G. et al. Radiotherapy of painful heel spur with two fractionation regimens. Strahlenther Onkol 193, 483–490 (2017). https://doi.org/10.1007/s00066-017-1116-y

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  • DOI: https://doi.org/10.1007/s00066-017-1116-y

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