Effect of Blinding With a New Pragmatic Placebo Needle

Abstract

Placebo control is a useful method for determining the efficacy of a therapy. In acupuncture researches, the preferred method for placebo control is acupuncture using a placebo needle that has a blunt tip and achieves no skin penetration.We performed a crossover study to validate the blinding effect of a new type of placebo needle. Sixty volunteers were randomized to receive acupuncture using 2 types of needles with different sequences: sequence AB, involving first the pragmatic placebo needle and then the real needle, and sequence BA, in a reverse order. Placebo acupuncture was performed by administering the placebo needle through an adhesive pad without skin penetration on the acupoints LI4, RN12, BL25, and BL36. Real acupuncture was performed by needling through the pad and penetrating the skin to 15 mm using a real needle on the same acupoints. The acupuncture was administered every other day with 3 sessions for 1 type of needle. The primary outcome was the perception of needle penetration. Besides degree of acupuncture pain, type, and degree of needle sensation, needle acceptability and factors influencing the subject blinding effect were assessed.Needle penetration was felt by 100%, 90% (54/60), 88.3% (53/60), and 95% (57/60) of volunteers receiving placebo acupuncture and 98.3% (59/60), 96.7% (58/60), 95% (57/60), and 95% (57/60) of volunteers receiving real acupuncture on LI4, RN12, BL25, and BL36, respectively. Differences of the volunteers’ perception of needle penetration between the placebo needle and real needle were not significant for the 4 acupoints (all P > 0.05). Volunteers experienced fewer distension sensations (P = 0.01), a lower degree of needle sensation (P = 0.007), and less pain (P = 0.006) during placebo acupuncture than during real acupuncture. The placebo needle was more easily accepted than the real needle (OR = 1.63, 95% CI, 1.01–2.64). The influences of age, sex, educational level, acupuncture experience, needle sensation, acupuncture pain, and needle acceptability on volunteers’ perception of needle penetration were not significant.The pragmatic placebo needle is a valid control for acupuncture research. It produces a good subject blinding effect with a similar appearance to conventional acupuncture needles and no skin penetration when applied.

Efficacy of acupuncture for degenerative lumbar spinal stenosis: protocol for a randomised sham acupuncture-controlled trial

“…However, owing to the characteristics of acupuncture, it is hard to use a placebo needle on patients. Based on a randomised controlled cross-over trial, the SA that will be implemented in this study will serve as a valid control25 because it can produce a good blinding effect to patients from two groups. This might balance the placebo effect between the two groups and reveal the efficacy of acupuncture for DLSS.…”

“…Thrusting and twisting motions will be used by acupuncturists to simulate the treatment and aid in blinding the patients. The sham needle used in this trial had a blunt tip similar to the Streitberger needle,24 which has been proven as a useful placebo control 25. Each placebo needle consists of four parts: the needle handle, needle body, blunt tip and adhesive pad (an illustration of the placebo needle used in this trial is shown as figure 2).…”

Acupuncture for Primary Sjögren Syndrome (pSS) on symptomatic improvements: study protocol for a randomized controlled trial

“…Since sham control is a useful method for determining the effectiveness of a therapy, we will choose a sham needle [12] that has a blunt tip and achieves no skin penetration. To apply the sham needles produces a good subject blinding effect, the reason of which is that they have a similar appearance to conventional acupuncture needles, however, without skin penetration.…”

Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes: study protocol for a randomized, sham acupuncture-controlled trial

“…We are also curious about this question, and we designed the sham acupuncture to use a blunt-tip needle on acupoints without penetration. According to the findings of our prior crossover study, this non-insertion-type needle is a valid sham control for acupuncture research and can achieve good subject blinding effects with a similar appearance to traditional acupuncture [39]. Given a sufficiently thin needle and the manipulation used (lifting, thrusting or rotating), even blunt tips can make participants feel the sensation of piercing.…”

“…Given a sufficiently thin needle and the manipulation used (lifting, thrusting or rotating), even blunt tips can make participants feel the sensation of piercing. Most of the participants were hardly able to distinguish this device from real acupuncture in the previous trial [39]. In addition, in the current trial, we will use BL 23, BL 33, BL 35 and SP 6 as the selected acupoints instead of conception vessel 1 (CV 1) and CV 4.…”