A Blinded Randomised Trial of Acupuncture (Manual and Electroacupuncture) Compared with a Non-Penetrating Sham for the Symptoms of Osteoarthritis of the Knee

Abstract

Objectives To compare the effect of acupuncture (manual and electroacupuncture) with that of a nonpenetrating sham ('placebo' needle) in patients with osteoarthritic knee pain and disability who are blind to the treatment allocation. Methods Acupuncture naïve patients with symptomatic and radiological evidence of osteoarthritis of the knee were randomly allocated to a course of either acupuncture or non-penetrating sham acupuncture using a sheathed 'placebo' needle system. Acupuncture points for pain and stiffness were selected according to acupuncture theory for treating Bi syndrome. Both manual and electrical stimulation were used. Response was assessed using the WOMAC index for osteoarthritis of the knee, self reported pain scale, the EuroQol score and plasma β-endorphin. The effectiveness of blinding was assessed. Results There were 34 patients in each group. The primary end point was the change in WOMAC pain score after the course of treatment. Comparison between the two treatment groups found a significantly greater improvement with acupuncture (mean difference 60, 95% CI 5 to 116, P= 0.035) than with sham. Within the acupuncture group there was a significant improvement in pain (baseline 294, mean change 95, 95% CI 60 to 130, P<0.001) which was not seen by those who had sham acupuncture (baseline 261, mean change 35, 95% CI -10 to 80, P=0.12). Similar effects within group, but not between groups, were seen with the secondary end points of WOMAC stiffness, WOMAC function, and self reported pain. One month after treatment the between group pain difference had been lost (mean difference 46; 95% CI -9 to 100, P=0.10) although the acupuncture group was still benefiting compared to baseline (mean difference 59; 95% CI 16 to 102, P=0.009). The EuroQol score, a generic measure of health related quality of life, was not altered by the treatments. A minority of patients correctly guessed their treatment group (41% in the acupuncture group and 44% in the control group). Plasma β-endorphin levels were not affected by either treatment. Conclusions Acupuncture gives symptomatic improvement for patients with osteoarthritis of the knee, and is significantly superior to non-penetrating sham acupuncture. The study did not confirm earlier reports of release of plasma β-endorphin during acupuncture.

Discrimination of Real and Sham Acupuncture Needles Using the Park Sham Device: A Preliminary Study

“…2 Randomized controlled trials examining the effects of acupuncture have started to use these sham devices and needles. [3][4][5] Studies examining the blinding effectiveness of the sham devices usually investigate similarities between the sensory intensities elicited by the sham and real needles that are felt by the participants. 1 If the sensory intensities to both needle types are not statistically different from each other, then it is indirectly inferred that the sham device is capable of blinding the participant.…”

Discrimination Accuracy between Real and Sham Needles using the Park Sham Device in the Upper and Lower Limbs

“…1 2 Randomised controlled trials examining the effects of acupuncture have started to use these sham devices and needles. [3][4][5] Credibility studies had generally found that the participantblinding effectiveness of these sham devices were fair or good. [6][7][8] Studies examining the blinding effectiveness of the sham devices usually use only one or a small number of acupoints.…”

Experimental study of low-frequency electroacupuncture-induced differentiation of bone marrow mesenchymal stem cells into chondrocytes

“…However, development of methods able to induce the committed differentiation of stem cells, has become the focus of tissue engineering development. Thus, an effective and safe modality of induction is valuable since potential safety concerns have arisen from the previous differentiation of BMSCs induced by agents (9,10).…”

“…Electroacupuncture (EA) is a modified acupuncture technique that utilizes electrical stimulation. Previous studies have demonstrated that EA has therapeutic effects on chondral defects including knee osteoarthritis (10)(11)(12) and produces cytokines with multiple biological activities in various types of diseases (13)(14)(15). In addition, animal experiments have shown that EA enhances BMSC differentiation into neuronal cells (16).…”