title: Designing an acupuncture study: II. The nationwide, randomized, controlled German acupuncture trials on low-back pain and gonarthrosis.
abstract: BACKGROUND
  In the nationwide German Acupuncture Trials (GERAC), verum acupuncture, mirroring the Traditional Chinese Medicine (TCM) acupuncture style, was tested against sham acupuncture and guideline standard therapy for the entities classified in the West as chronic low back pain (LBP) and gonarthrosis (GON).
  
  
  OBJECTIVE
  The objective was to develop broadly consensual acupuncture and control protocols for the treatment of LBP and GON in the GERAC trials.
  
  
  METHODS
  Extensive literature study and consultation with acupuncture experts were consulted. Personal interviews, both free and structured, e-mail discussions, and phone conferences were used as well.
  
  
  RESULTS
  Broadly consensual acupuncture protocols for LBP and GON for verum and invasive sham acupuncture were developed. They included semistandardized point combinations with clearly described point selection rules based on TCM acupuncture diagnosis. A procedure was developed to help ensure homogenous treatment quality in a large multicenter trial.
  
  
  CONCLUSIONS
  With 1162 randomized patients for LBP and 1039 patients for GON, the GERAC study design allowed acupuncture to be tested in a naturalistic environment. The rigorous study design and large number of physician investigators guaranteed a high external validity for the results. The results will help determine the significance of Chinese acupuncture in the context of Western medicine for the treatment of LBP and GON.
authors.affiliation: Acupuncture Research Group, Duesseldorf, Germany. a.molsberger@facm.de
authors.forename: Albrecht F
authors.initials: AF
authors.lastname: Molsberger
authors.forename: Konrad
authors.initials: K
authors.lastname: Streitberger
authors.forename: Juergen
authors.initials: J
authors.lastname: Kraemer
authors.forename: Carmen Schade
authors.initials: CS
authors.lastname: Brittinger
authors.forename: Steffen
authors.initials: S
authors.lastname: Witte
authors.forename: Gabriele
authors.initials: G
authors.lastname: Boewing
authors.forename: Michael
authors.initials: M
authors.lastname: Haake
mesh_terms: D015669:Acupuncture Points; D015670:Acupuncture Therapy / Q000592:standards*; D019091:Critical Pathways / Q000458:organization & administration*; D019317:Evidence-Based Medicine / Q000592:standards; D005260:Female; D005858:Germany; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D008297:Male; D015337:Multicenter Studies as Topic / Q000592:standards; D020370:Osteoarthritis, Knee / Q000628:therapy*; D017410:Practice Guidelines as Topic / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design; D016896:Treatment Outcome