title: International research project to devise a protocol to test the effectiveness of acupuncture on painful shoulder.
abstract: OBJECTIVE
  To describe in detail the questions and deliberations leading to the development of a methodologically rigorous protocol to test the effectiveness of acupuncture on painful shoulder.
  
  
  METHODS
  Randomized controlled trial using three groups, including one control group.
  
  
  METHODS
  A hospital in the north of Italy treating at least 8-10 painful shoulders a day, with physician/acupuncturists, physiotherapists, and assessors available to participate in the study.
  
  
  METHODS
  Sixty patients with monolateral painful shoulder. A list of exclusion criteria is given.
  
  
  METHODS
  Acupuncture + mobilization; mobilization alone (control); ear acupuncture + mobilization.
  
  
  METHODS
  Severity of pain, scored on a visual analogue scale (VAS) and on the McGill Pain Questionnaire and restriction of range of motion (ROM) of the shoulder joint. Voluntary use of pain medication, Tenoxicam 20 mg, was added to the protocol.
  
  
  RESULTS
  The research team developed a protocol and methodology that avoids the common flaws and difficulties of previous clinical trials on acupuncture.
  
  
  CONCLUSIONS
  Physicians and acupuncture specialists will benefit from the advice and support of a project group consisting of experienced clinicians, researchers, and statisticians when designing and preparing clinical trials on acupuncture and other complementary and alternative therapies.
authors.affiliation: Cochrane Collaboration for Alternative and Complementary Medicine. markro@tin.it
authors.forename: M
authors.initials: M
authors.lastname: Romoli
authors.forename: D
authors.initials: D
authors.lastname: van der Windt
authors.forename: P
authors.initials: P
authors.lastname: Giovanzana
authors.forename: G
authors.initials: G
authors.lastname: Masserano
authors.forename: F
authors.initials: F
authors.lastname: Vignali
authors.forename: E
authors.initials: E
authors.lastname: Quirico
authors.forename: A
authors.initials: A
authors.lastname: Giommi
mesh_terms: D015670:Acupuncture Therapy; D002985:Clinical Protocols; D006801:Humans; D007391:International Cooperation; D007558:Italy; D059408:Pain Management; D026741:Physical Therapy Modalities; D012720:Severity of Illness Index; D012785:Shoulder Joint; D011795:Surveys and Questionnaires; D016896:Treatment Outcome