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The Erlangen Dose Optimization Trial for radiotherapy of benign painful shoulder syndrome

Long-term results

Die Erlanger Dosisoptimierungsstudie zur Strahlentherapie beim benignen schmerzhaften Schultersyndrom

Langzeitergebnisse

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An Erratum to this article was published on 26 April 2014

Abstract

Background and purpose

To evaluate the long-term efficacy of pain reduction by two dose-fractionation schedules for radiotherapy of painful shoulder syndrome.

Patients and methods

Between February 2006 and February 2010, 312 evaluable patients were recruited for this prospective trial. All patients received low-dose orthovoltage radiotherapy. One course consisted of 6 fractions in 3 weeks. In the case of insufficient pain remission after 6 weeks, a second course was administered. Patients were randomly assigned to one of two groups to receive single doses of either 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before radiotherapy, as well as immediately after (early response), 6 weeks after (delayed response) and approximately 3 years after (long-term response) completion of radiotherapy using a questionnaire-based visual analogue scale (VAS) and a comprehensive pain score (CPS).

Results

Median follow-up was 35 months (range 11–57). The overall early, delayed and long-term response rates for all patients were 83, 85 and 82 %, respectively. The mean VAS scores before treatment and those for early, delayed and long-term response in the 0.5- and 1.0-Gy groups were 56.8 ± 23.7 and 53.2 ± 21.8 (p = 0.16); 38.2 ± 36.1 and 34.0 ± 24.5 (p = 0.19); 33.0 ± 27.2 and 23.7 ± 22.7 (p = 0.04) and 27.9 ± 25.8 and 32.1 ± 26.9 (p = 0.25), respectively. The mean CPS values before treatment and those for early, delayed and long-term response were 9.7 ± 3.0 and 9.5 ± 2.7 (p = 0.31); 6.1 ± 3.6 and 5.4 ± 3.6 (p = 0.10); 5.3 ± 3.7 and 4.1 ± 3.7 (p = 0.05) and 4.0 ± 3.9 and 5.3 ± 4.4 (p = 0.05), respectively. No significant differences in the quality of the long-term response were found between the 0.5- and 1.0-Gy arms (p = 0.28).

Conclusion

Radiotherapy is an effective treatment for the management of benign painful shoulder syndrome. For radiation protection reasons, the dose for a radiotherapy series should not exceed 3.0 Gy.

Zusammenfassung

Hintergrund

Untersuchung der Langzeiteffektivität zweier Dosisfraktionierungskonzepte bei der Strahlentherapie von Patienten mit schmerzhaftem Schultersyndrom.

Patienten und Methoden

Zwischen 2006 und 2010 wurden 312 auswertbare Patienten in diese prospektive und randomisierte Phase-IV-Studie eingeschlossen. Alle Patienten erhielten die Bestrahlung in niedrigdosierter Orthovolt-Technik. Eine Bestrahlungsserie bestand aus 6 Fraktionen/3 Wochen. Bei ungenügendem Ansprechen der Schmerzsymptomatik nach 6 Wochen wurde eine zweite Bestrahlungsserie durchgeführt. Die Patienten wurden auf die beiden Studienarme randomisiert und erhielten je nach Ergebnis Einzeldosen von 0,5 bzw. 1,0 Gy. Der Endpunkt der vorliegenden Analyse war die Schmerzreduktion. Die Schmerzintensität wurde vor, direkt nach („early response“), 6 Wochen nach („delayed response“) sowie etwa 3 Jahre nach der Strahlentherapie („long-term response“) mittels visueller Analogskala (VAS) und einem umfassenden Schmerzscore (CPS) gemessen.

Ergebnisse

Die mediane Nachbeobachtungszeit für Langzeitevaluation betrug 35 Monate (Spanne 11–57 Monate). Die Raten für das frühe, verzögerte und Langzeitansprechen aller Patienten betrugen 83, 85 und 82 %. Die mittleren VAS-Werte vor Behandlung sowie für das frühe, verzögerte und das Langzeitansprechen waren für die 0,5-Gy- und die 1,0-Gy-Gruppe jeweils 56,8 ± 23,7 und 53,2 ± 21,8 (p = 0,16), 38,2 ± 36,1 und 34,0 ± 24,5 (p = 0,19), 33,0 ± 27,2 und 23,7 ± 22,7 (p = 0,04) sowie 27,9 ± 25,8 und 32,1 ± 26,9 (p = 0,25). Die entsprechenden mittleren CPS-Werte vor Behandlung sowie für das frühe, verzögerte und das Langzeitansprechen betrugen jeweils 9,7 ± 3,0 und 9,5 ± 2,7 (p = 0,31), 6,1 ± 3,6 und 5,4 ± 3,6 (p = 0,10), 5,3 ± 3,7 und 4,1 ± 3,7 (p = 0,05) sowie 4,0 ± 3,9 und 5,3 ± 4,4 (p = 0,05). Zwischen den beiden Studienarmen konnten keinerlei statistisch signifikante Unterschiede in der Qualität des Langzeitansprechens festgestellt werden (p = 0,28).

Schlussfolgerung

Die Strahlentherapie ist langfristig eine effektive Maßnahme zur Behandlung des schmerzhaften Schultersyndroms. Aus Strahlenschutzgründen sollte eine Gesamtdosis von 3 Gy pro Bestrahlungsserie nicht überschritten werden.

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Acknowledgements

This work was supported in part by the German Federal Ministry of Education and Research (GREWIS, 02NUK017G) and the European Commission (DoReMi, European Network of Excellence, contract number 249689).

Compliance with ethical guidelines

Conflict of interest. O. Ott, S. Hertel, U.S. Gaipl, B. Frey, M. Schmidt and R. Fietkau state that there are no conflicts of interest.

All studies on humans described in the present manuscript were carried out with the approval of the responsible ethics committee and in accordance with national law and the Helsinki Declaration of 1975 (in its current, revised form). Informed consent was obtained from all patients included in studies.

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Authors and Affiliations

  1. Department of Radiation Oncology, University Hospital Erlangen, Universitätsstr. 27, 91054, Erlangen, Germany

    O.J. Ott, S. Hertel, U.S. Gaipl, B. Frey, M. Schmidt & R. Fietkau

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  1. O.J. Ott
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  2. S. Hertel
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  3. U.S. Gaipl
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  5. M. Schmidt
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Correspondence to O.J. Ott.

Additional information

An erratum to this article is available at http://dx.doi.org/10.1007/s00066-014-0679-0.

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Ott, O., Hertel, S., Gaipl, U. et al. The Erlangen Dose Optimization Trial for radiotherapy of benign painful shoulder syndrome. Strahlenther Onkol 190, 394–398 (2014). https://doi.org/10.1007/s00066-013-0520-1

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