Objective: The goal of this paper is to describe the characteristics of physicians and their interventions in a large, multicentre randomised trial of acupuncture for tension-type headache known as ART TTH, in order to enable acupuncturists to assess the study interventions.
Methods: Participating physicians were recruited whose qualifications met or surpassed those of physicians currently accredited for providing acupuncture by state health funding agencies in Germany. Semi-standardised treatment strategies for acupuncture and minimal acupuncture were developed in a consensus process with acupuncture experts. A total of 270 patients suffering from episodic or chronic tension-type headache were randomised to 12 sessions of semi-standardised acupuncture (three predefined 'basic' points, recommendations for additional points given, but individual choice of additional points possible), standardised minimal acupuncture (superficial needling of at least 5 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list. Forty two physicians, trained and experienced in acupuncture, from 28 centres in Germany participated in the trial.
Results: The median duration of acupuncture training of trial physicians was 500 hours (range 140 to 1350 hours). Physicians had 10 (< 1 to 25) years acupuncture experience. The three 'basic' points (GB20, GB21 and LR3) were treated in 96%, 82% and 97% of sessions, respectively. Frequently treated optional points included LI4 (67%), SP6 (50%) and ST36 (46%). Ten of the 42 physicians stated that they would have treated patients differently outside the trial. The trial found a significant effect of acupuncture over waiting list but not over minimal acupuncture.
Conclusions: In general, trial physicians complied well with the predefined interventions. A relevant minority of participating trial physicians stated that they would have treated patients differently outside the trial.