Sham Needling Research Articles

Remote Effect of Lower Limb Acupuncture on Latent Myofascial Trigger Point of Upper Trapezius Muscle: A Pilot Study

Objectives. To demonstrate the use of acupuncture in the lower limbs to treat myofascial pain of the upper trapezius muscles via a remote effect. Methods. Five adults with latent myofascial trigger points (MTrPs) of bilateral upper trapezius muscles received acupuncture at Weizhong (UB40) and Yanglingquan (GB34) points in the lower limbs. Modified acupuncture was applied at these points on a randomly selected ipsilateral lower limb (experimental side) versus sham needling on the contralateral lower limb (control side) in each subject. Each subject received two treatments within a one-week interval. To evaluate the remote effect of acupuncture, the range of motion (ROM) upon bending the contralateral side of the cervical spine was assessed before and after each treatment. Results. There was significant improvement in cervical ROM after the second treatment (P = 0.03) in the experimental group, and the increased ROM on the modified acupuncture side was greater compared to the sham needling side (P = 0.036). Conclusions. A remote effect of acupuncture was demonstrated in this pilot study. Using modified acupuncture needling at remote acupuncture points in the ipsilateral lower limb, our treatments released tightness due to latent MTrPs of the upper trapezius muscle.

The effect of dry needling in the treatment of myofascial pain syndrome: a randomized double-blinded placebo-controlled trial

The objective of this study was to test the hypothesis that dry needling is more effective than sham dry needling in the treatment of myofascial pain syndrome (MPS). This was a prospective, double-blinded, randomized-controlled study conducted in an outpatient clinic. Thirty-nine subjects with established myofascial trigger points were randomized into two groups: study group (N = 22) and placebo group (N = 17). Dry needling was applied using acupuncture needles, and sham dry needling was applied in the placebo group. The treatment was composed of six sessions which were performed in 4 weeks; the first four sessions were performed twice a week (for 2 weeks) and the last two, once a week (for 2 weeks). The visual analog scale (VAS) and Short Form-36 (SF-36) were used. When compared with the initial values, VAS scores of the dry needling group following the first and sixth sessions were significantly lower (p = 0.000 and p < 0.000, respectively). When VAS scores were compared between the groups, the first assessment scores were found to be similar, but the second and third assessment scores were found to be significantly lower in the dry needling group (p = 0.034 and p < 0.001, respectively). When SF-36 scores of the groups were compared, both the physical and mental component scores were found to be significantly increased in the dry needling group, whereas only those of vitality scores were found to be increased significantly in the placebo (sham needling) group. The present study shows that the dry needling treatment is effective in relieving the pain and in improving the quality of life of patients with MPS.

Activated and deactivated functional brain areas in the Deqi state: A functional MRI study.

We compared the activities of functional regions of the brain in the Deqi versus non-Deqi state, as reported by physicians and subjects during acupuncture. Twelve healthy volunteers received sham and true needling at the Waiguan (TE5) acupoint. Real-time cerebral functional MRI showed that compared with non-sensation after sham needling, true needling activated Brodmann areas 3, 6, 8, 9, 10, 11, 13, 20, 21, 37, 39, 40, 43, and 47, the head of the caudate nucleus, the parahippocampal gyrus, thalamus and red nucleus. True needling also deactivated Brodmann areas 1, 2, 3, 4, 5, 6, 7, 9, 10, 18, 24, 31, 40 and 46.

The needling sensation: A factor contributing to the specific effects of acupuncture?

Acupuncture is a complex intervention, and there are both specific and non-specific influences associated with its therapeutic benefit. Although large randomized controlled trials (RCT) and systematic reviews have demonstrated the efficacy of acupuncture, the conclusions are controversial due to the lack of a significant difference in the results between real and sham acupuncture. This similarity may be due to the omission of important components of the acupuncture treatment itself, such as the needling sensation. The needling sensation is considered to represent an important component of acupuncture. Despite this importance, several RCTs have lacked data on whether the needling sensation has been achieved. From a Traditional Chinese Medicine (TCM) perspective, the needling sensation, deQi, is a combination of unique sensations that are interpreted as the flow of Qi, or “vital energy.” Furthermore, acupuncture is believed to be successful only upon the arrival of “vital energy,” Qi. This state is suggested to be essential to the specific therapeutic effect of acupuncture. From a biomedical perspective, acupuncture excites sensory receptors and nerve fibers in the stimulated tissue, resulting in a needling sensation. Moreover, acupuncture induces both the deactivation of a limbic–paralimbic–neocortical network in the brain (the default mode network and the anti-correlated task-positive network) and the activation of somatosensory regions. A distinct needling sensation is associated with a marked deactivation of these brain networks, whereas the lack of a needling sensation (as during sham needling) is associated with significantly less deactivation. Conversely, when acupuncture induces sharp pain sensations, there is an activation of these networks instead. In a clinical context, this difference means that the therapist needs to identify a stimulation intensity that is scaled to the needling response of each patient, i.e., a sharp uncomfortable pain sensation during the needle stimulation should be avoided.Both the empirical bases of TCM and biomedical acupuncture research suggest that the therapist should strive for a needling sensation during an acupuncture treatment. If such a sensation is not achieved, are the specific effects of acupuncture likely smaller? This conclusion suggests that deQi is part of a proper acupuncture treatment and that the experience of a needling sensation should universally be assessed and reported in all types of clinical and experimental trials.

Spinal Cord Mechanism Involving the Remote Effects of Dry Needling on the Irritability of Myofascial Trigger Spots in Rabbit Skeletal Muscle

Hsieh Y-L, Chou L-W, Joe Y-S, Hong C-Z. Spinal cord mechanism involving the remote effects of dry needling on the irritability of myofascial trigger spots in rabbit skeletal muscle. Objective To elucidate the neural mechanisms underlying the remote effects produced by dry needling rabbit skeletal muscle myofascial trigger spots (MTrSs) via analyses of their endplate noise (EPN) recordings. Design Experimental animal controlled trial. Setting An animal laboratory of a university. Animals Male New Zealand rabbits (N=96) (body weight, 2.5–3.0kg; age, 16–20wk). Intervention Animals received no intervention for neural interruption in group I, transection of the tibial nerve in group II, transection of L5 and L6 spinal cord in group III, and transection of the T1 and T2 spinal cord in group IV. Each group was further divided into 4 subgroups: animals received ipsilateral dry needling, contralateral dry needling, ipsilateral sham needling, or contralateral sham needling of gastrocnemius MTrSs. Main Outcome Measures EPN amplitudes of biceps femoris (BF) MTrSs. Results BF MTrS mean EPN amplitudes significantly increased ( P<.05) initially after gastrocnemius verum needling but reduced to a level significantly lower ( P<.05) than the preneedling level in groups I and IV with ipsilateral dry needling or contralateral dry needling, and in group II with contralateral dry needling (but not ipsilateral dry needling). No significant EPN amplitude changes were observed in BF MTrS in group III or in the control animals receiving superficial needling (sham). Conclusion This remote effect of dry needling depends on an intact afferent pathway from the stimulating site to the spinal cord and a normal spinal cord function at the levels corresponding to the innervation of the proximally affected muscle.

Is Placebo Acupuncture What It Is Intended to Be?

Randomized, placebo-controlled clinical trials are recommended for evaluation of a treatment's efficacy with the goal of separating the specific effects (verum) from the non-specific ones (placebo). In order to be able to carry out placebo-controlled acupuncture trials, minimal/sham acupuncture procedures and a sham acupuncture needle has been used with the intention of being inert. However, clinical and experimental results suggest that sham/minimal acupuncture is not inert since it is reported that both verum acupuncture and sham/minimal acupuncture induce a significant alleviation of pain. This alleviation is as pronounced as the alleviation obtained with standard treatment and more obvious than the one obtained with placebo medication or by the use of waiting list controls. These results also suggest that sham acupuncture needles evoke a physiological response. In healthy individuals sham acupuncture results in activation of limbic structures, whereas a deactivation is seen in patients with pain, i.e. results from healthy individuals do not reflect what is seen in clinical conditions. Also, depending on the etiology of pain (or any under clinical condition under investigation), the response to sham acupuncture is varying. The acupuncture ritual may also be seen as an emotional focused therapy allowing for psychological re-orientation. Sham needling in such context may be as powerful as verum acupuncture. We recommend that the evaluated effects of acupuncture could be compared with those of standard treatment, also taking the individual response into consideration, before its use or non-use is established.

Remote Effects of Dry Needling on the Irritability of the Myofascial Trigger Point in the Upper Trapezius Muscle

To investigate the remote effect of dry needling on the irritability of a myofascial trigger point in the upper trapezius muscle. Thirty-five patients with active myofascial trigger points in upper trapezius muscles were randomly divided into two groups: 18 patients in the control group received sham needling, and 17 patients in the dry-needling group received dry needling into the myofascial trigger point in the extensor carpi radialis longus muscle. The subjective pain intensity, pressure pain threshold, and range of motion of the neck were assessed before and immediately after the treatment. Immediately after dry needling in the experimental group, the mean pain intensity was significantly reduced, but the mean pressure threshold and the mean range of motion of cervical spine were significantly increased. There were significantly larger changes in all three parameters of measurement in the dry-needling group than that in the control group. This study demonstrated the remote effectiveness of dry needling. Dry needling of a distal myofascial trigger point can provide a remote effect to reduce the irritability of a proximal myofascial trigger point.

Developing and Validating a Sham Acupuncture Needle

to develop a sham needle device and test its credibility as a control for acupuncture when used in a randomised controlled trial of myofascial trigger point needling in patients with whiplash associated pain. sham needles were developed by blunting true acupuncture needles. Whiplash injured patients (<16 weeks duration) were randomly allocated to receive either true acupuncture or the "placebo" sham needle control. The true and sham needling interventions were delivered using the same standardised procedure. Patients were informed that they would receive either real or placebo needles, and asked (i) to state which treatment they believed they had received (treatment belief); (ii) to complete the four item Borkovec and Nau self-assessment credibility scale. Results were compared between groups and the analysis explored whether a patient's previous experience of acupuncture was related to their treatment belief. Other outcomes of the study will be reported elsewhere. 20 patients received the true acupuncture and 21 received the sham. There was no significant difference between the treatment beliefs of the two groups (chi(2) = 1.51; p>0.2) nor in the mean item scores on the Borkovec and Nau credibility scale (t test, p values ranged from 0.38 to 0.87). Of the patients in the sham acupuncture group who had previous experience of acupuncture, none recorded receiving the sham intervention. within the context of this pilot study, the sham acupuncture intervention was found to be a credible control for acupuncture. This supports its use in a planned, definitive, randomised controlled trial on a similar whiplash injured population.

Resolving Paradoxes in Acupuncture Research: A Roundtable Discussion

Peter M. Wayne: We’re going to be discussing the workshop that we held at the North American Research Conference on Complementary and Integrative Medicine (NARCCIM) in May 2009. The workshop was designed to present the findings from a Society for Acupuncture Research (SAR) board retreat, which focused on ‘‘Paradoxes in Acupuncture Research: Strategies for Moving Forward.’’ The paradoxes, in turn, had emerged during the 2007 SAR International Conference that reviewed the progress in our field in the decade since the 1997 NIH Consensus Development Conference on Acupuncture. The conference was a great success, with more than 300 attendees and support from the National Institutes of Health (NIH), conventional medical schools, schools of acupuncture and Oriental medicine, and a variety of other national and international organizations. The conference concluded that the field of acupuncture research had made great progress since 1997. Many rigorous phase II and III randomized controlled trials were completed for acupuncture treatment of a wide variety of medical conditions, and some very strong basic research was performed with state-of-the-art tools to examine biochemical and physiologic correlates of acupuncture. Important progress was also made with respect to control procedures and other aspects of clinical research design. Summaries of the conference have been published in the Journal of Alternative and Complementary Medicine. But in putting together this work, we identified two paradoxes. Paradox One is that an increasing number of large clinical trials have reported that true acupuncture does not significantly outperform sham acupuncture, a finding apparently at odds with traditional theories regarding acupuncture point specificity and needling techniques. Paradox Two is that while many studies with animal and human experimental models have reported physiologic effects that vary as a function of needling parameters, the extent to which these parameters influence therapeutic outcomes in clinical trials is unclear. As the SAR board prepared a White Paper to highlight these paradoxes and discuss research directions to resolve them, the opportunity arose to present our thinking at the NARCCIM conference. Richard Hammerschlag: That gives us a good sense of where we’re at: How we came to focus on these paradoxes, our work in clarifying them, and the research we’re proposing as necessary to resolve them. Regarding the first paradox, many people, and especially practitioners, were quite disturbed after the 2007 SAR Conference by the conclusion, especially on the basis of the largescale German trials that were presented, that it either doesn’t matter where we place acupuncture needles or that something is amiss with the research design of such studies. As researchers, we need to be open to exploring both possibilities. For me, the question with regard to this paradox is twofold. First, sham needling is not inert and appears to produce a level of benefit that is procedure related. Second, inclusion of a sham-treatment arm in a randomized controlled trial may reduce the level of effectiveness of the active-treatment arm (by reducing patient expectancy of receiving an effective treatment from 100% to 50%). My concern is that by utilizing a control procedure that has treatment benefit and by following a research design that may decrease the effectiveness of a verum or active treatment, we’re generating type II errors and getting false-negative results. For example, sham needling—especially if it’s invasive—may induce microtrauma through local physiologic changes in microcirculation or cytokines that promote healing in the body. A recent review indicates that in acupuncture trials that have had both a sham arm and a nontreatment arm in addition to the active-treatment arm, the difference between the sham and nontreatment arms seems to have been greater than that between the placebo and nontreatment arms in conventional pharmaceutical trials. So this again raises a possibility that sham treatment is not inert, and that some

A cerebral functional imaging study by positron emission tomography in healthy volunteers receiving true or sham acupuncture needling

Our recent studies have demonstrated that needling in Baihui, Shuigou and Shenmen enhances glucose metabolism in the frontal lobes, thalamus, temporal lobe, and the lentiform nucleus in vascular dementia. This study examined the effect of true, sham and overt needling in Waiguan (TE5) on cerebral changes by positron emission tomography (PET) technique. Eighteen healthy volunteers were randomized to receive overt control, true or sham needling therapy. To manipulate true needling, a needle was inserted into 15±2mm into Waiguan and “deqi” was achieved by proper needle manipulation. For sham needling, needles with a blunt tip were pushed against the skin as the shaft moved into the handle, giving an illusion of insertion. For overt placebo, blunt needles were used and subjects did not receive any needling penetration. The tracer used was 18fluoride-deoxygluocse. PET images obtained were processed and analyzed by the SPM2 software. Compared with overt needling, brain areas BA7, 13, 18, 19, 21, 22, 27, 38, 40, 42 and 45 in Waiguan true needling group were significantly activated and areas BA4, 6, 7, 19, 22 and 41 in sham needling group showed obvious activation. Compared to sham needling group, marked activation points were found in the areas of BA13 and 42 and left cerebellum in true needling group. Our study revealed a marked difference in brain metabolic changes between true and sham needling in Waiguan. Further studies are needed to explore the cerebral changes in patients with acupuncture and the pathological implications.

Acupuncture – Self-Appraisal and the Reward System

Acupuncture is an ancient therapy with a variety of different explanatory models. A cascade of physiological effects has been reported, both in the peripheral and the central nervous system, following the insertion of a needle or light tapping of the skin. Clinical trials testing the specific claims of acupuncture have generally tried to focus on testing the efficacy of applying specific techniques and/or specified points. However, different conditions may respond differently to different modes of stimulation. Recently, it was demonstrated that both superficial and deep needling (with de qi/Hibiki) resulted in amelioration of patellofemoral pain and unpleasantness. The pleasurable aspect of the acupuncture experience has largely been ignored as it has been considered secondary to its pain alleviating effects. This aspect of acupuncture treatment is likely to be related to activation of self-appraisal and the reward system. When a patient seeks a therapist there are expectations of a specific effect. These expectations are partly based on self-relevant phenomena and self-referentia introspection and constitute the preference. Also, when asked about the effect of the treatment, processes that orientate pre-attentive anticipatory or mnemonic information and processes that mediate self-reflection and recollection are integrated together with sensory detection to enable a decision about the patient's perception of the effect of acupuncture treatment. These 'self-appraisal' processes are dependent on two integrated networks: a ventral medial prefrontal cortex-paralimbic-limbic 'affective' pathway and a dorsal medial prefrontal cortex-cortical-hippocampal 'cognitive' pathway. The limbic structures are implicated in the reward system and play a key role in most diseases and illness responses including chronic pain and depression, regulating mood and neuromodulatory responses (eg sensory, autonomic, and endocrine). The pleasurable and neuromodulatory aspects of acupuncture as well as 'placebo needling' may partly be explained by the activation or deactivation of limbic structures including the hippocampus, amygdala, and their connections with the hypothalamus. In patients with patellofemoral pain, the effects of superficial and deep needling remained for six months. These long term pain-alleviating effects have been attributed to activation of pain inhibiting systems in cortical and subcortical pathways. When considering long term effects the cortical-cerebellar system needs to be taken into account. The cortical-cerebellar system is probably central to the development of neural models that learn and eventually stimulate routinely executed (eg motor skills) and long term (eg pain alleviation) cognitive processes. These higher order cognitive processes are initially mediated in prefrontal cortical loci but later shift control iteratively to internal cerebellar representations of these processes. Possibly part of the long term healing effects of acupuncture may be attributed to changes in the cerebellar system thereby sparing processing load in cortical and subcortical areas. As cortical and subcortical structures are activated and/or de-activated following stimulation of receptors in the skin, disregarding site, 'placebo or sham needling' does not exist and conclusions drawn on the basis that it is an inert control are invalid. 'Self' may be seen as a shifting illusion, ceaselessly constructed and deconstructed, and the effect of acupuncture may reflect its status (as well as that of the therapist).

Experiences of Acupuncturists in a Placebo-Controlled, Randomized Clinical Trial

This paper describes the experiences of 8 licensed acupuncturists in a placebo-controlled randomized clinical trial (RCT). This information is important to the design and conduct of high-quality trials. We conducted a RCT (N=135) with a 2-week placebo run-in followed by 4 weeks of twice-weekly treatments comparing genuine to sham acupuncture (using the Streitberger placebo needle) in the treatment of arm pain caused by repetitive use. At the end of this study, we conducted written structured interviews with 8 participating acupuncturists. The acupuncturists were not aware of the study's results at the time of these interviews. The questions focused on their experiences in the study, adherence to study protocols, their thoughts about the technical and ethical issues involved in using a sham needling device, and their expectations of trial outcomes. The questions were motivated by expressions of concerns the acupuncturists raised in feedback groups during the course of the study, and our desire to improve further trials. The acupuncturists differed widely in their comfort levels with the research methods used, their adherence to the study protocol, and their expectations of trial outcomes. We conclude that careful monitoring of acupuncturists, including observation of treatments and frequent meetings to support them throughout the trial, is necessary to maintain a high degree of quality control.

Difference of needle sensation between sham needling and genuine needling in acupuncture naive Japanese subjects

Difference of needle sensation between sham needling and genuine needling in acupuncture naive Japanese subjects

Acupuncture Points Have Subjective (Needing Sensation) and Objective (Serum Cortisol Increase) Specificity

This randomised, controlled trial was to determine if blinded subjects are able to discriminate between needle stimulation at traditional acupuncture points and sham points, based on the appreciation of needling sensation (de qi); and if needling at traditional points is related to the objective parameter of serum cortisol increase. Manual acupuncture at traditional and sham points was applied to 20 healthy male students in a single-blind crossover design. Needle sensation (de qi) was reported as significantly stronger with traditional needling than with sham acupuncture. Needling at traditional acupuncture points moderately, but significantly, increased serum cortisol values at 5, 25 and 45 minutes after cessation of stimulation. Needle sensation did not correlate with serum cortisol levels. Experience of pain did not show a difference between traditional and sham needling, nor did it correlate with serum cortisol levels. We conclude that acupuncture points show subjective (needling sensation) and objective (serum cortisol increase) specificity.