ACUPUNCTURE FOR DENTAL PAIN--TESTING A MODEL

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Third molar extraction and other dental surgeries commonly produce pain, swelling, and transient functional disability. Analgesic medications, used to treat postoperative pain, often produce local or systemic side effects. Acupuncture for pain control may offer an effective adjunctive treatment to medication. However, rigorous scientific research to evaluate the efficacy and safety of acupuncture is needed. The aims of this study are: 1) to develop and test two minimal sham acupuncture control procedures; 2) to compare the analgesic effects of real acupuncture to a) minimal sham acupuncture and b) inert placebo acupuncture; 3) to evaluate patient blinding; 4) to determine whether patients' attitudes are associated with outcomes; and 5) to assess acupuncture safety. The proposed two-phase study includes double-blind, randomized controlled trial methods. This study will test the hypothesis that acupuncture can produce better analgesic effects than control on postoperative dental pain using a partially impacted third molar extraction model. The first phase (pilot study, n=40 per group) will develop and validate two sham procedures to test the efficacy of acupuncture. The second phase (sample size to be determined by first phase data) will test the efficacy and safety of real acupuncture compared to the sham model developed in phase I and a placebo model. Both phases will utilize a standardized pain assessment instrument to measure pain intensity and pain free time at six hours postoperatively through a seven-day follow-up period.