title: Acupuncture Randomized Trials (ART) in patients with chronic low back pain and osteoarthritis of the knee - design and protocols.
abstract: BACKGROUND
  We report on the study design and protocols of two randomized controlled trials (Acupuncture Randomized Trials = ART) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee, respectively.
  
  
  OBJECTIVE
  To investigate whether acupuncture is more efficacious than (a) no treatment or (b) minimal acupuncture in the treatment of low back pain and osteoarthritis.
  
  
  METHODS
  Two randomized, controlled, multicenter trials with three treatment arms and a total follow-up time of 52 weeks.
  
  
  METHODS
  30 practitioners and outpatient units in Germany specialized in acupuncture treatment.
  
  
  METHODS
  300 patients will be included in each study. In the low back pain trial, patients will be included according to clinical diagnosis. In the osteoarthritis pain trial, patients will be included according to the American College of Rheumatology criteria.
  
  
  METHODS
  Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) minimal acupuncture at non-acupuncture points (75 patients), or (3) no treatment for two months followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks.
  
  
  METHODS
  The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters: pain intensity as measured by a visual analogue scale (VAS; 0-100 mm) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score (WOMAC) in the osteoarthritis trial.
  
  
  CONCLUSIONS
  The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.
authors.affiliation: Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Klinikum Charit , Humboldt-Universität zu Berlin, Berlin, Germany. benno.brinkhaus@charite.de
authors.forename: B
authors.initials: B
authors.lastname: Brinkhaus
authors.forename: C
authors.initials: C
authors.lastname: Becker-Witt
authors.forename: S
authors.initials: S
authors.lastname: Jena
authors.forename: K
authors.initials: K
authors.lastname: Linde
authors.forename: A
authors.initials: A
authors.lastname: Streng
authors.forename: S
authors.initials: S
authors.lastname: Wagenpfeil
authors.forename: D
authors.initials: D
authors.lastname: Irnich
authors.forename: J
authors.initials: J
authors.lastname: Hummelsberger
authors.forename: D
authors.initials: D
authors.lastname: Melchart
authors.forename: S N
authors.initials: SN
authors.lastname: Willich
mesh_terms: D015670:Acupuncture Therapy; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000628:therapy*; D012107:Research Design; D016896:Treatment Outcome