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Chinese acupuncture is widely accepted in western countries, and a number of clinical trials are testing Chinese acupuncture, especially for chronic low back pain (cLBP). However, little is known about how practitioners perform acupuncture treatment in daily clinical work and whether treatment styles differ among practitioners and countries.To investigate whether styles of Chinese acupuncture treatment for cLBP are heterogeneous among different practitioners and countries.Literature review, a prospective survey of international experts using a questionnaire with open and closed questions, and personal interviews.Data were collected from 18 experts in 10 different countries. The typical treatment regimen for cLBP, based on a composite of experts' responses, consisted of 11 sessions lasting 25 minutes each, held twice weekly. The typical practitioner inserted 12 needles, would select individual points according to channels and syndromes, and would identify syndromes such as kidney deficiency (yin and yang), cold dampness, and qi and blood stagnation. Preferred points were BL 23, BL 40, GB 34, BL 54, BL 60, BL 54, and Huatuo, although there was a high variation in additional local and distal points. Generally speaking, no expert would administer fewer than 6 treatments, omit Ahshi points, restrict needle insertion to 1 cm or less, or adhere solely to fixed points for all patients.For the first time it has been shown that there is a broad consistency in fundamental aspects of Chinese acupuncture for cLBP across different kinds of practitioners and different countries. These data can be used as minimal standards for the design and funding of future clinical trials.

The efficacy of acupuncture treatment for chronic low-back pain has not been reliably proven because of a lack of good quality studies, leading to the necessity of developing the German Acupuncture Trial for Chronic Low-Back Pain (GERAC-cLBP) study.The aim is to assess the effectiveness of traditional Chinese acupuncture for chronic low-back pain compared to sham acupuncture and with a conventional standard therapy.This trial is a nationwide, multicenter, randomized, prospective, partially blinded study. The primary endpoint is the success rate after 6 months. Success is defined as an improvement of 33% or more of three pain-related items on the Van-Korff Pain Score or an improvement of 12% or more in the disability measured by the Hanover Functional Ability Questionnaire. Assessment of the effectiveness of the blinding of patients to the form of acupuncture they received will be conducted. All clinical endpoints are assessed centrally by blinded independent observers. The sample size, with a total of 1062 patients to be enrolled, is based on power calculations. Independent central randomization, data collection, data processing, and statistical analysis are provided. Success rates will be tested for differences using two-sided Fisher exact tests. In the primary analysis, all tests will be carried out on the basis of the intention-to-treat principle. Secondary analyses will be conducted according to protocol approaches.The pilot phase of the trial started in February 2002, the estimated duration of the study is 2.5 years. Enrollment is anticipated to be completed in the winter of 2003.The GERAC-cLBP study is currently the world's largest controlled trial of the effectiveness of acupuncture treatment for low-back pain. It will contribute to the evaluation of efficacy by means of evidence based medicine.