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

被引:105
作者
Molsberger, Albrecht F. [1 ]
Schneider, Thomas [2 ]
Gotthardt, Hermann [3 ]
Drabik, Attyla [4 ,5 ]
机构
[1] Ruhr Univ Bochum, D-44780 Bochum, Germany
[2] Dreifaltigkeits Krankenhaus Cologne, D-50933 Cologne, Germany
[3] Klin Porta Westfal, D-32547 Bad Oeynhausen, Germany
[4] Univ Dusseldorf, Dept Med Stat, D-4000 Dusseldorf, Germany
[5] Univ Hosp Munster, Ctr Clin Trials, D-48129 Munster, Germany
关键词
Shoulder pain; Pain management; Conservative treatment; Complementary medicine; Acupuncture; Randomised clinical trial; RCT; PLACEBO-CONTROLLED TRIAL; LOW-BACK-PAIN; ROTATOR CUFF; IMPINGEMENT SYNDROME; FROZEN SHOULDER; CLINICAL-TRIAL; GROWTH-FACTOR; ELECTROACUPUNCTURE; TENDINITIS; EXPRESSION;
D O I
10.1016/j.pain.2010.06.036
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
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. (C) 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
引用
收藏
页码:146 / 154
页数:9
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