A Protocol for the Validation of Novel Sham Acupuncture in Patients Who Have Had a Stroke

Background: A sham control group enhances the quality of clinical trials by controlling for the placebo effect. To ensure rigorous blinding to enhance the quality of clinical trials on acupuncture treatment it is important to develop a more sophisticated sham needle. Discrepancies in perceived needling sensation and treatment expectations between patients and healthy volunteers may affect study outcomes. Thus, it may be inappropriate to generalize the findings of a sham needle validation study in healthy adults to patients who have had a stroke. Therefore, this is a protocol for a clinical trial in patients who have had a stroke to validate a newly developed sham needle to be used in double-blind trials.Methods: Sixty-six patients who have had a stroke will be randomly assigned to the verum or sham needle group using a 1:1 ratio. As the verum and sham needles are identical in appearance, both participants and practitioners will be unaware of the needle type used for acupuncture treatment. After the acupuncture procedure, the participants will be asked whether they believe they received the verum or sham acupuncture treatment and indicate penetration, pain, and de qi sensation for each acupuncture point. A between-group comparison of needle-related adverse events will be performed.Discussion: This double-blind randomized controlled trial will be the first study to validate a newly developed sham acupuncture needle for patients who have had a stroke. The results of this study may inform clinical trial study design for acupuncture treatment of patients who have had a stroke.