Research: HAAKE and others,

Listed in Issue 100

Abstract

HAAKE and others, Orthopedic Department, University of Regensburg, Bad Abbach, Germany, m.haake@rheuma-ortho-zentrum.de, present a preliminary report on the German multicentre trial of acupuncture for chronic low back pain.

Background

This study has been necessitated by the lack of good evidence for the efficiency of acupuncture as a treatment for chronic low back pain.

Methodology

This trial is a nationwide, multicentre, randomized, prospective, partially blinded study. The primary outcome measure is the success rate after 6 months, where 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 disability as measured by the Hanover Functional Ability Questionnaire. An assessment of the effectiveness of the blinding of patients to the form of acupuncture they receive will be performed. All clinical outcomes will be assessed by blinded observers. The sample size will be 1062 patients. Success rates will be tested for differences using two-sided Fisher exact tests.

Results

The pilot phase of the trial has started in February 2002. The estimated duration of the whole study is 2.5 years. Enrolment is expected to be completed at the end of 2003.

Conclusion

The German multicentre trial of acupuncture is currently the world's largest controlled trial of acupuncture for chronic low back pain. It will contribute substantially to the body of evidence-based medicine.

References

Haake M, Mueller-Hans H, Schade-Brittinger C, Prinz H, Basler HD, Streitberger K, Schaefer H, Molsberger A. The German multicenter, randomized, partially blinded, prospective trial of acupuncture for chronic low-back pain: a preliminary report on the rationale and design of the trial. The Journal of Alternative and Complementary Medicine 9 (5): 763-770, Oct 2003.

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