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


METHODS
Three-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).


METHODS
Participating trial physicians and interventions.


RESULTS
Forty-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.


CONCLUSIONS
For 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.
Brinkhaus
Benno
B
Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany. benno.brinkhaus@charite.de
Witt
Claudia M
CM
Jena
Susanne
S
Linde
Klaus
K
Streng
Andrea
A
Irnich
Dominik
D
Hummelsberger
Josef
J
Hammes
Michael
M
Pach
Daniel
D
Melchart
Dieter
D
Willich
Stefan N
SN
D015670:Acupuncture Therapy / Q000379:methods*; D000328:Adult; D000554:Ambulatory Care Facilities; D002983:Clinical Competence; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians' / Q000458:organization & administration*; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome