title: Benign painful shoulder syndrome: initial results of a single-center prospective randomized radiotherapy dose-optimization trial.
abstract: OBJECTIVE
  To compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with benign painful shoulder syndrome.
  
  
  METHODS
  Between February 2006 and February 2010, 312 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions in 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS).
  
  
  RESULTS
  The overall response rate for all patients was 83% directly after and 85% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 56.8 ± 23.7 and 53.2 ± 21.8 (p = 0.158), 38.2 ± 26.1 and 34.0 ± 24.5 (p = 0.189), and 33.0 ± 27.2 and 23.7 ± 22.7 (p = 0.044), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 9.7 ± 3.0 and 9.5 ± 2.7 (p = 0.309), 6.1 ± 3.6 and 5.4 ± 3.6 (p = 0.096), 5.3 ± 3.7 and 4.1 ± 3.7 (p = 0.052), respectively. Despite a slight advantage in the VAS analysis for the 1.0 Gy group for delayed response, the CPS analysis revealed no statistically significant differences between the two single-dose trial arms for early (p = 0.652) and delayed response quality (p = 0.380).
  
  
  CONCLUSIONS
  Radiotherapy is an effective treatment option for the management of benign painful shoulder syndrome. Concerning radiation protection, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy.
authors.affiliation: Department of Radiation Oncology, University Hospital Erlangen, Universitätsstr. 27, 91054, Erlangen, Germany. oliver.ott@uk-erlangen.de
authors.forename: O J
authors.initials: OJ
authors.lastname: Ott
authors.forename: S
authors.initials: S
authors.lastname: Hertel
authors.forename: U S
authors.initials: US
authors.lastname: Gaipl
authors.forename: B
authors.initials: B
authors.lastname: Frey
authors.forename: M
authors.initials: M
authors.lastname: Schmidt
authors.forename: R
authors.initials: R
authors.lastname: Fietkau
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000528:radiation effects; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D020069:Shoulder Pain / Q000175:diagnosis / Q000209:etiology / Q000532:radiotherapy*