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

Journal of Alternative and Complementary Medicine

Volumn 9, Issue 5, 2003, Pages 763-770

  Haake, Michael ^a   Müller, Hans Helge ^b   Schade Brittinger, Carmen ^b   Prinz, Helge ^b   Basler, Heinz Dieter ^b   Streitberger, Konrad ^c   Schäfer, Helmut ^b   Molsberger, Albrecht ^d  

^a UNIVERSITY OF REGENSBURG   (Germany)

^b PHILIPPS UNIVERSITY MARBURG   (Germany)

^c UNIVERSITY OF HEIDELBERG   (Germany)

^d Centre for Clinical Acupuncture and Research   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ACUPUNCTURE; ARTICLE; CHRONIC DISEASE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISABILITY; DOUBLE BLIND PROCEDURE; EVIDENCE BASED MEDICINE; FEMALE; FUNCTIONAL ASSESSMENT; GERMANY; HUMAN; LOW BACK PAIN; MAJOR CLINICAL STUDY; MALE; MEASUREMENT; METHODOLOGY; MULTICENTER STUDY; PAIN ASSESSMENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; STANDARD; TIME; TREATMENT OUTCOME; TREATMENT PLANNING;

ACUPUNCTURE THERAPY; CHRONIC DISEASE; CLINICAL PROTOCOLS; DOUBLE-BLIND METHOD; FEMALE; GERMANY; HUMANS; LOW BACK PAIN; MALE; PROSPECTIVE STUDIES; RESEARCH DESIGN; TIME FACTORS;

EID: 0242664854     PISSN: 10755535     EISSN: None     Source Type: Journal    
DOI: 10.1089/107555303322524616     Document Type: Article

References (31)

1. Bergquist-Ullman M, Larsson U. Acute low back pain in industry. A controlled prospective study with special reference to therapy and confounding factors. Acta Orthop Scand 1977;170(suppl):111-117.
2. Collins SL, Edwards J, Moore RA, Smith LA, McQuay HJ. Seeking a simple measure of analgesia for mega-trials: Is a single global assessment good enough? Pain 2001; 91:189-194.
3. Deyo RA, Weinstein JN. Low back pain. N Eng J Med 2001;344:363-370.
4. Ernst E, White AR. Acupuncture for back pain: A meta-analysis of randomized controlled trials. Arch Intern Med 1998;20:2235-2241.
5. European Agency for the Evaluation of Medicinal Products-Human Medicines Evaluation Unit. ICH Topic E 6, Guideline for Good Clinical Practice, CPMP/ICH/135/95. 1996; Online document at: www.emea.eu.int/pdfs/human/ich/013595en.pdf
6. European Agency for the Evaluation of Medicinal Products-Human Medicines Evaluation Unit. ICH Topic E 9, Guideline for Statistical Principles in Clinical Trials, CPMP/ICH/363/96E9. 1998; Online document at: www.emea.eu.int/pdfs/human/ich/036396en.pdf
7. Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL. Defining the clinically important difference in pain outcome measures. Pain 2000;88:287-294.
8. Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149-158.
9. Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey nine countries: Results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol 1998;51:1171-1178.
10. Guidelines for the Treatment of Low Back Pain [in German]. 2. Aufl., Düsseldorf; Nexus GmbH, 2000.
11. Kohlmann T, Raspe H. The Hannover Functional Questionnaire in ambulatory diagnosis of functional disability caused by backache. Rehabilitation 1996;35:1-8.
12. Lao L, Ezzo J, Berman BM, Hammerschlag R. Assessing clinical efficacy of acupuncture: Considerstions for designing future acupuncture trials. In: Stux G, Hammerschlag R, eds. Clinical Acupuncture Scientific Basis. Berlin/Heidelberg/New York: Springer Verlag, 2001:187-209.
13. Marcus R, Peritz E, Gabriel KR. On closed testing procedures with special reference to ordered analysis of variance. Biometrika 1976;63:655-660.
14. Molsberger A, Böwing G, Haake M, Meier U, Winkler J, Molsberger F. Acupuncture in diseases of the locomotor system-status of research and clinical application [in German]. Orthopäde 2002;31:536-543.
15. Molsberger A, Mau J, Pawelec DB, Winkler J, Molsberger F. Does acupuncture improve the orthopedic management of chronic low back pain-A randomized, blinded, controlled trial with 3 months follow up. Pain 2002;99:579-587.
16. Müller HH, Schäfer H. Adaptive group sequential designs for clinical trials: Combining the advantages of adaptive and of classical group sequential approaches. Biometrics 2001;57:886-891.
17. National Institutes of Health. NIH Consensus conference: acupuncture. JAMA 1998;17:1518-1524.
18. Pförringer W. Backache: Cost of illness study [in German]. Z Orthop Ihre Grenzgeb 1997, 135:Oa10-Oa11.
19. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975;31:103-115.
20. Raspe H, Kohlmann T. Population surveys for disorders characterized by pain: A methodological review. J Epidemiol Commun Health 1994;48:531-537.
21. Roese I, Kohlmann T, Raspe H. Measuring functional capacity in backache patients in rehabilitation: A comparision of standardized questionnaires. Rehabilitation 1996;35:103-108.
22. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet 1998;352:364-365.
23. Stux G, Birch S. Proposed standards of acupuncture treatment for clinical studies. In: Stux G, Hammerschlag R, eds. Clinical Acupuncture Scientific Basis. Berlin/Heidelberg/New York: Springer Verlag, 2001:170-185.
24. Thomas E, Silman AJ, Croft PR, Papageorgiou AC, Jayson MI, Macfarlane GI. Predicting who develops chronic low back pain in primary care: A prospective study. BMJ 1999;318:1662-1667.
25. van den Hoogen HJ, Koes BW, Deville W, van Eijk JT, Bouter LM. The prognosis of low back pain in general practice. Spine 1997;22:1515-1521.
26. Van Tulder MW, Cherkin DC, Berman B, Lao L, Koes BW. Acupuncture for low back pain (Cochrane Review). In: The Cochrane Library, Issue 1, 2001.
27. Van Tulder MW, Koes BW, Bouter L. A cost-of-illness study of back pain in the Netherlands. Pain 1995; 62:233-240.
28. Vickers A, Wilson P, Kleijnen J. Acupuncture. Qual Saf Health Care 2002;11:92-97.
29. Vincent CA, Lewith G. Placebo controls for acupuncture studies. J R Soc Med 1995;88:199-202.
30. Vincent CA. Credibility assessment in trials af accupuncture. Comp Med Res 1990;4:8-11.
31. Von Korff M, Ormel J, Keefe FJ, Dworkin SF. Grading the severity of chronic pain. Pain 1992;50:133-149.