• J Altern Complement Med · Sep 2006

    Randomized Controlled Trial Multicenter Study Controlled Clinical Trial

    Interventions and physician characteristics in a randomized multicenter trial of acupuncture in patients with low-back pain.

    • Benno Brinkhaus, Claudia M Witt, Susanne Jena, Klaus Linde, Andrea Streng, Dominik Irnich, Josef Hummelsberger, Michael Hammes, Daniel Pach, Dieter Melchart, and Stefan N Willich.
    • Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany. benno.brinkhaus@charite.de
    • J Altern Complement Med. 2006 Sep 1; 12 (7): 649-57.

    ObjectiveDescriptions of the interventions used in acupuncture studies are often incomplete. The aim of this paper is to describe participating trial physicians and interventions in a randomised trial of acupuncture for low back pain.DesignThree-armed, randomized, controlled multicenter trial with 1-year follow-up. A total of 301 patients with low-back pain were randomized to 12 sessions of semistandardized acupuncture (at least six local and two distant points needled bilaterally from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), minimal acupuncture (superficial needling of at least 6 of 10 predefined, bilateral, distant nonacupuncture points), or a waiting list control (2 months no acupuncture followed by semistandardised acupuncture described above).Outcome MeasuresParticipating trial physicians and interventions.ResultsForty-five (45) physicians specializing in acupuncture (mean age 44 +/- 7.8 years, 23 (51%) female) in 30 outpatient centers in Germany provided the interventions. The median duration of acupuncture training of trial physicians was 350 hours (range 140-2508). The most frequently reported Chinese diagnosis was Kidney deficiency (39%), followed by qi and Blood stagnation (24%), and bi syndrome (20%). The total number of needles used was 17.3 +/- 4.2 in the acupuncture group compared to 12.3 +/- 1.2 in the minimal acupuncture group. In total, 40 physicians (89%) stated that they would have treated patients similarly or in exactly the same way outside of the trial, whereas 5 (11%) stated that they would have treated patients differently.ConclusionsFor most trial physicians, the semistandardized acupuncture strategy used in this trial was an acceptable compromise for an efficacy study. However, a relevant minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

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