German Randomized Acupuncture Trial for chronic shoulder... : PAIN (original) (raw)

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German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) – A pragmatic, controlled, patient-blinded, multi-centre trial in an outpatient care environment

Molsberger, Albrecht F.a,*; Schneider, Thomasb; Gotthardt, Hermannc; Drabik, Attylad,e

a_Ruhr-University Bochum, Orthopaedic Surgery and Research, 44780 Bochum, Germany_

b_Orthopaedic Surgery, Dreifaltigkeits-Krankenhaus Cologne, 50933 Cologne, Germany_

c_Klinik Porta Westfalica, 32547 Bad Oeynhausen, Germany_

d_Department of Statistics in Medicine, Heinrich Heine University Düsseldorf, Germany_1

e_Centre for Clinical Trials, University Hospital Münster, 48129 Münster, Germany_

*Corresponding author. Tel.: +49 211 866880; fax: +49 211 8668818.

E-mail address:[email protected]

Submitted March 11, 2009; revised June 14, 2010; accepted June 30, 2010.

☆This study was supported by a grant of the German Ministry of Education, Science and Research. Reference No. 01KT9411/9.

Abstract

The German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) comprised 424 outpatients with chronic shoulder pain (CSP) ≥6 weeks and an average pain score of VAS ≥50 mm, who were randomly assigned to receive Chinese acupuncture (verum), sham acupuncture (sham) or conventional conservative orthopaedic treatment (COT). The patients were blinded to the type of acupuncture and treated by 31 office-based orthopaedists trained in acupuncture; all received 15 treatments over 6 weeks. The 50% responder rate for pain was measured on a VAS 3 months after the end of treatment (primary endpoint) and directly after the end of the treatment (secondary endpoint). Results: In the ITT (n = 424) analysis, percentages of responders for the primary endpoint were verum 65% (95% CI 56–74%) (n = 100), sham 24% (95% CI 9–39%) (n = 32), and COT 37% (95% CI 24–50%) (n = 50); secondary endpoint: verum 68% (95% CI 58–77%) (n = 92), sham 40% (95% CI 27–53%) (n = 53), and COT 28% (95% CI 14–42%) (n = 38). The results are significant for verum over sham and verum over COT (p < 0.01) for both the primary and secondary endpoints. The PPP analysis of the primary (n = 308) and secondary endpoints (n = 360) yields similar responder results for verum over sham and verum over COT (p < 0.01). Descriptive statistics showed greater improvement of shoulder mobility (abduction and arm-above-head test) for the verum group versus the control group immediately after treatment and after 3 months. The trial indicates that Chinese acupuncture is an effective alternative to conventional orthopaedic treatment for CSP.