Rethinking Sham Controls in Acupuncture Trials for Pain Management: Random-Point Acupuncture as a Strategy to Evaluate Efficacy and Acupoint Specificity.

Randomized controlled trials of acupuncture for pain management commonly rely on sham procedures intended to function as placebo controls. However, accumulating evidence suggests that widely used sham approaches, such as superficial needling or non-penetrating devices applied near therapeutic acupoints, may not be physiologically inert. Neuroimaging studies and clinical trials indicate that minimal needling or tactile stimulation can activate neural pathways involved in pain modulation, raising concern that sham acupuncture may represent a low-intensity intervention rather than a true placebo. This issue may attenuate observed differences between treatment and control groups and complicate interpretation of acupuncture trials for chronic pain conditions, including low back pain. In this Perspective, we discuss limitations of current sham acupuncture designs and propose reconsideration of an underutilized control strategy: random-point acupuncture. In this approach, real needling is performed at acupoints randomly selected from locations unrelated to the treatment protocol. This design preserves procedural credibility and participant blinding while minimizing overlap with protocol-specific therapeutic points. Importantly, comparing outcomes between true acupuncture and random-point acupuncture allows investigators to directly evaluate the role of acupoint specificity. We argue that incorporating such controls could improve the methodological rigor of acupuncture trials and provide clearer insights into the mechanisms underlying acupuncture analgesia. PERSPECTIVE: Random-point acupuncture offers a pragmatic sham-control strategy for acupuncture trials. By systematically excluding potentially therapeutic and condition-relevant acupoints and assigning participant-specific random-point sets, this approach may reduce unintended therapeutic effects while supporting blinding, thereby strengthening evaluation of acupuncture efficacy and acupoint specificity.