International research project to devise a protocol to test the effectiveness of acupuncture on painful shoulder

Objectives: To describe in detail the questions and deliberations leading t o the development of a methodologically rigorous protocol to test the effec tiveness of acupuncture on painful shoulder. Design: Randomized controlled trial using three groups, including one contr ol group. Settings/location: A hospital in the north of Italy treating at l east 8-10 painful shoulders a day, with physician/acupuncturists, physiothe rapists, and assessors available to participate in the study. Subjects: Sixty patients with monolateral painful shoulder. A list of exclu sion criteria is given. Interventions: Acupuncture + mobilization; mobilization alone (control); ea r acupuncture + mobilization. Outcome measures: Severity of pain, scored on a visual analogue scale (VAS) and on the McGill Pain Questionnaire and restriction of range of motion (R OM) of the shoulder joint. Voluntary use of pain medication, Tenoxicam 20 m g, 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 acupunctu re. Conclusions: Physicians and acupuncture specialists will benefit from the a dvice 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.