Description and validation of a noninvasive placebo acupuncture procedure.

OBJECTIVE To evaluate a simulated acupuncture technique for use in randomized controlled trials assessing the efficacy of acupuncture for low-back pain. SETTING The clinic of an accredited acupuncture college in Seattle, Washington. SUBJECTS Acupuncture-naïve enrollees of Group Health Cooperative who had visited their primary care provider with a complaint of back pain that persisted for at least 3 months. EXPERIMENTAL DESIGN In the first experiment, subjects received six insertions of real needles and six pokes with a toothpick in a guidetube in a two-period crossover design. In the second experiment, subjects were randomly assigned to receive either a complete treatment with real acupuncture needles or a simulated treatment using a toothpick in a guidetube. OUTCOMES In the first experiment, we compared subjects' perceptions about which implement was used for each "insertion" while in the second, we compared the perceptions (e.g., acupuncturist's warmth and caring, the reasonableness of acupuncture as a treatment) and pain relief of those who received an acupuncture treatment using needles to those receiving simulated acupuncture. RESULTS In the first experiment, the toothpick insertions were perceived as slightly more like real needling than the real needling (mean ratings of 2.8 and 2.1, respectively; p = 0.08). In the second experiment, 52% percent of those receiving the simulated needling versus 65% of those receiving real acupuncture believed they were "definitely" or "probably" receiving real acupuncture (p = 0.33). Perceptions of acupuncture, as measured by a credibility questionnaire, were similar in the two groups. Those receiving real acupuncture were more likely to report immediate pain relief, and this was the factor most predictive of the subject's belief about which treatment they had received (p = 0.02). CONCLUSIONS The simulated acupuncture procedure evaluated in this study represents a reasonable control treatment for acupuncture-naïve individuals in randomized controlled trials assessing the efficacy of acupuncture for low-back pain.