Objectives: 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.
Design: Randomized controlled trial using three groups, including one control group.
Settings/location: 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.
Subjects: Sixty patients with monolateral painful shoulder. A list of exclusion criteria is given.
Interventions: Acupuncture + mobilization; mobilization alone (control); ear 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 (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.