Verum Acupuncture Research Articles

Efficacy of acupuncture treatment for chronic spontaneous urticaria: study protocol for a randomised controlled trial

IntroductionChronic spontaneous urticaria (CSU) is a troublesome dermatological problem that can have a significant impact on quality of life. Previous studies have indicated that acupuncture may be beneficial for patients...

Acupuncture for Subthreshold Depression: Study Protocol for a Randomized Controlled Trial.

BackgroundSubthreshold depression refers to a state of mental sub-health that has depressive symptoms but does not meet the diagnostic criteria for major depressive disorder. It is a strong risk factor for depression and is related to an increase in suicide and mortality. Studies suggest that acupuncture may be effective in the treatment of subthreshold depression, but no evidence has proven that the efficacy of acupuncture for subthreshold depression is a specific therapeutic effect or a placebo effect.MethodsThis will be a prospective, randomized, controlled, and double-blind study of 64 patients with subthreshold depression. They will be randomly assigned as verum or minimal acupuncture group members. Patients in the verum acupuncture group will receive acupuncture at the acupoints, and those in the minimal acupuncture group will receive minimal acupuncture at non-acupoints. The interventions will be delivered over an 8-week period. The primary outcome measure will be the Hamilton Depression Scale-17 (HAMD-17). The secondary outcome measures will be the 9-item Patient Health Questionnaire (PHQ-9), 7-item Generalized Anxiety Disorder (GAD-7), and SF-12v2 Health Survey. The assessments will occur at baseline, 4 weeks, 8 weeks, and during a follow-up period.DiscussionThe protocol uses a randomized controlled trial to examine the effectiveness of acupuncture for subthreshold depression and to further study the mechanisms of its effect.

Immediate acupuncture with GB34 for biliary colic: protocol for a randomised controlled neuroimaging trial

IntroductionAs the main manifestation of gallstone disease, biliary colic (BC) is an episodic attack that brings patients severe pain in the right upper abdominal quadrant. Although acupuncture has been documented...

Analgesia Effect of Verum and Sham Acupuncture Treatments in Primary Dysmenorrhea: A MRI Pilot Study.

Acupuncture is an alternative treatment for primary dysmenorrhea (PDM). However, mechanisms by which acupuncture exerts its analgesic properties are still unclear. This study aimed to explore the cerebral blood flow (CBF) response to verum and sham acupuncture treatments, and further investigate whether pre-treatment CBF is capable of assessing symptom changes after interventions. A total of 11 PDM patients in the verum group and 12 patients in the sham group participated in this study. Pain rating index (PRI), CBF, and gonadal hormone levels were acquired before and after 8-week treatments. Both verum and sham acupuncture treatments exert its analgesic effect on PDM after intervention as PRI reduced (p < 0.05). Blood gonadal levels were not significantly different after acupuncture in both groups (all p > 0.05). In the verum group, intervention-related decreases in CBF were observed in the right dorsal anterior cingulate cortex. In the sham group, regions identified as showing reductions in CBF after acupuncture included the left ventromedial prefrontal cortex, left caudate, and left insula. Patients with higher baseline CBF in the left precuneus and right hippocampus were accompanied with worse treatment response to acupuncture intervention. Mechanisms of verum and sham acupuncture treatments are dissimilar as manifested by different brain responses.

Acupuncture Treatment Associated with Functional Connectivity Changes in Primary Dysmenorrhea: A Resting State fMRI Study.

Primary dysmenorrhea (PDM) is the most commonly encountered gynecological problem in reproductive-age women. Acupuncture has been suggested as an effective treatment of PDM that may modulate descending pain modulation systems. In the present study, we used resting-state functional magnetic resonance imaging to investigate possible changes in descending pain modulation systems after acupuncture treatment in women with PDM. Thirty-four right-handed adult women with PDM participated in this randomized, single-blinded, sham-controlled study. Each patient was randomly allocated to an 8-week verum or sham acupuncture intervention on the bilateral Sanyinjiao (SP6). Resting-state functional magnetic resonance imaging was conducted before, during, and after the intervention to measure the spontaneous activity in brain. After the 8-week intervention, both verum and sham groups reported decreased menstrual pain. However, the cessation of decreased functional connectivity (FC) between periaqueductal gray matter and the regions associated with affective pain modulation and attention-related pain modulation were found in the verum but not in the sham group after the 8-week intervention. More decreased FC has been found in the region associated with non-specific effects of acupuncture intervention after the early stage of acupuncture intervention. These results indicated that verum acupuncture may intercept the altered FC in descending pain modulation systems in PDM.

Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial

BackgroundPost-traumatic stress disorder (PTSD) is a significant public health problem, affecting approximately 7% of the general population and 13–18% of the combat Veteran population. The first study using acupuncture for PTSD in a civilian population showed large pre- to post-treatment effects for an empirically developed verum protocol, which was equivalent to group cognitive behavior therapy and superior to a wait-list control. The primary objective of this study is to determine both clinical and biological effects of verum acupuncture for combat-related PTSD in treatment-seeking US Veterans.MethodsThis is a two-arm, parallel-group, prospective randomized placebo-controlled clinical trial. The experimental condition is verum acupuncture and the placebo control is sham (minimal) acupuncture in 1-h sessions, twice a week for 12 weeks. Ninety subjects will provide adequate power and will be allocated to group by an adaptive randomization procedure. The primary outcome is change in PTSD symptom severity from pre- to post-treatment. The secondary biological outcome is change from pre- to post-treatment in psychophysiological response, startle by electromyographic (EMG) eyeblink. Assessments will be conducted at pre-, mid-, post-, and 1-month post-treatment, blind to group allocation. Intent-to-treat analyses will be conducted.DiscussionThe study results will be definitive because both clinical and biological outcomes will be assessed and correlated. Issues such as the number needed for recruitment and improvement, use of sham acupuncture, choice of biological measure, and future research need will be discussed.Trial registrationClinicalTrials.gov NCT02869646. Registered on 17 August 2016.

Acupuncture Relieved Chemotherapy-Induced Peripheral Neuropathy in Patients with Breast Cancer: A Pilot Randomized Sham-Controlled Trial

Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling side effect caused by neurotoxic chemotherapy. This randomized controlled trial aimed to evaluate the effect of manual acupuncture on CIPN. Twenty eligible breast cancer patients receiving taxane chemotherapy treatment were recruited and randomly divided into verum acupuncture and sham acupuncture groups. Each group received 15 treatments over 9 weeks. Quantitative tactile detection thresholds were measured using Semmes–Weinstein monofilament testing (SWM). The World Health Organization Quality of Life scale (WHOQOL-BREF), the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and the Brief Pain Inventory-Short Form (BPI-SF) were measured before and after treatment. The between-group comparison of SWM revealed that the verum acupuncture group had more improvement of touch perception thresholds compared to the sham acupuncture group. The average pain severity in the BPI-SF of the verum acupuncture group was significantly lower than that of the sham acupuncture group. There were no significant differences in the FACT/GOG-Ntx trial outcome index and WHOQOL-BREF scores between the acupuncture and sham groups. The results suggest that acupuncture can alleviate the neuropathic pain of CIPN and improve touch perception thresholds.

Evidence of Potential Mechanisms of Acupuncture from Functional MRI Data for Migraine Prophylaxis.

To summarize the clinical neuroimaging evidence pertaining to the potential mechanisms of acupuncture for migraine prophylaxis. From a descriptive perspective, converging evidence from recent neuroimaging studies, mainly from functional MRI (fMRI) studies, has demonstrated that when compared with sham acupuncture, verum acupuncture could normalize the decrease of the functional connectivity of the rostral ventromedial medulla-trigeminocervical complex (RVM/TCC) network, frontal-parietal network, cingulo-opercular networks, and default mode network and could normalize sensorimotor network connectivity with sensory-, affective-, and cognitive-related brain areas. These areas overlap with those of the pain matrix. Verum acupuncture works in a more targeted and unique manner compared with sham acupuncture in patients with migraine. These findings from neuroimaging studies may provide new perspectives on the validation of acupoints specificity and confirm the central modulating effects of acupuncture as a migraine prevention treatment. However, the exact mechanism by which acupuncture works for migraine prophylaxis remains unclear and warrants investigation. Future studies with larger sample sizes are still needed to confirm the current results and to further evaluate the complex and specific effects of acupuncture by analyzing different stimulus conditions, such as verum vs. sham acupuncture, deqi vs. no deqi, different acupuncture points or meridians, and different manipulation methods. Moreover, instead of focusing on the changes in a single area of the brain, researchers should focus more on the relationships among the functional connectivity network of brain areas such as the RVM/TCC, thalamus, anterior cingulate cortex (ACC), superior temporal gyrus (STG), and supplementary motor area (SMA) to explore the underlying mechanism of the effects of acupuncture.

Acupuncture is associated with a positive effect on odour discrimination in patients with postinfectious smell loss\u2014a controlled prospective study

IntroductionSmell disorders are common in the general population and occur e.g., after infections, trauma or idiopathically Treatment strategies for smell loss range from surgery, medication to olfactory training, depending on the pathology, but they are limited This study examined the effect of acupuncture on olfactory function.MethodsSixty patients with smell loss following infections of the upper respiratory tract were included in this investigation Half of the study group were randomly assigned to verum acupuncture and the other half to sham acupuncture Olfaction was measured by means of the “Sniffin’ Sticks” test battery (odour threshold, discrimination and identification).ResultsCompared to sham acupuncture, verum was associated with an improvement of smell function as measured by the TDI score (p = 0.039) The improvement was largely determined by improvement in odour discrimination, and was significantly better in patients with a shorter duration of the disorder.ConclusionThe present results suggest that acupuncture is an effective supplementary treatment option for patients with olfactory loss.

Effect of acupuncture treatment in patients with mild to moderate atopic dermatitis: a randomized, participant- and assessor-blind sham-controlled trial

BackgroundAtopic dermatitis (AD) is a chronic recurrent inflammatory skin disease that affects 1–3% of adults worldwide. Currently, it is not possible to completely cure AD; therefore, alternative treatments need to be developed to meet the patients’ needs. Here, based on our previous pilot study, we conducted the first confirmatory randomized controlled trial to evaluate the effect of acupuncture in patients with mild to moderate AD.MethodsA randomized, participant- and assessor-blinded, sham-controlled trial was designed with an intervention period twice-weekly for 4 weeks and a 4-week follow-up. We equally allocated 36 participants to the verum acupuncture (VA) and sham acupuncture (SA) groups. The main outcome measure was the change in SCORing Atopic Dermatitis index (SCORAD) score before and after treatment.ResultsA total of 36 participants, aged 19 to 38 years, were enrolled, and 35 were included in the intention-to-treat analyses. The mean change in total SCORAD score differed significantly among the two groups at 4 weeks after randomization (P < .0001): the mean difference was − 11.83 (7.05) in the VA group and 0.45 (7.77) in the SA group. The mean SCORAD score substantially decreased 2-weeks after starting the acupuncture treatment and continued to improve for at least 4 weeks after the end of the treatment in the VA group compared to the SA group (each P < .0001). No serious adverse events were observed.ConclusionsTwice-weekly acupuncture treatment was effective in reducing AD symptoms in patients with mild to moderate AD without serious adverse events.Trial registrationClinical Research Information Service Identifier: KCT0002796.

Manual acupuncture versus sham acupuncture and usual care for the prevention of primary dysmenorrhea (PD): study protocol for a randomized controlled trial

BackgroundPrimary dysmenorrhea (PD) is a leading cause of dysmenorrhea among adolescent girls. Manual acupuncture may be considered as an effective treatment for PD, but high-quality evidence remains limited. This trial aims to evaluate the efficacy and safety of acupuncture for the prevention of PD as compared with sham acupuncture and usual care.Methods/designThis is a three-arm, randomized, controlled clinical trial in which the patients, assessors, and statisticians will be blinded. A total of 300 acupuncture-naive patients who were diagnosed as PD will be randomly allocated to the verum acupuncture, sham acupuncture, or usual care groups in a 2:2:1 ratio. Patients in the verum acupuncture group will receive manual acupuncture at specific acupuncture points with penetrating needling, while those in the sham acupuncture group will receive non-penetrating needling at non-acupuncture points. They will be given five sessions over a menstrual cycle for 3 menstrual cycles. Patients in the usual care group will receive health education and informed to receive manual acupuncture for free after waiting for 7 menstrual cycles. The primary outcome will be the change from baseline in the Cox Menstrual Symptom Scale Score (CMSS). The secondary outcomes will be the changes in Massachusetts General Hospital Acupuncture Sensation Scale (MASS), visual analog scale (VAS), Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2), Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory II (BDI- II), Acupuncture Expectancy Scale (AES), 60-item NEO Personality Inventory-Short Form (NEO-FFI), and acute medication intake. The adverse events will be recorded at every visit. The analyses will be performed base on a full analysis set (FAS) and a per-protocol set (PPS).DiscussionThis study may provide high-quality evidence regarding the efficacy and safety of manual acupuncture for PD. In addition, the results of this study will help to identify the efficacy of acupuncture due to the specific effects of acupuncture or placebo effects of acupuncture ritual.Trial registrationClinical Trials.gov NCT02783534. Registered on 26 May 2016

Acupuncture in persons with an increased stress level-Results from a randomized-controlled pilot trial.

BackgroundIn today’s Western societies a high percentage of people experience increased or chronic stress. Acupuncture could serve as treatment for persons affected adversely by the increased stress.MethodsThe AkuRest study was a two-centre randomized controlled pilot study in adult persons with increased stress levels. Participants were randomly allocated to one of three groups: verum acupuncture treatment, sham acupuncture, and a waiting control group. The feasibility of the study was assessed. In addition, effects on stress level (measured by the Perceived Stress Questionnaire (PSQ-20)) and other variables were assessed at the end of treatment and a 3-month follow-up.ResultsAltogether, N = 70 persons were included in the study. At the end of the treatment 15.7% were lost to follow-up. The adherence to the protocol was good: 82.9% of the participants completed 100% of their treatment. The stress level of the participants was high at baseline (mean PSQ-20 score 75.5, SD = 8.2). Effect sizes (ES) at T1 showed that verum and sham acupuncture were superior to the waiting condition in reducing stress (ES (verum) = -1.39, 95%-CI = [-2.11; -0.67]: ES (sham) = -1.12, CI = [-1.78;-0.44]). At follow-up, effect sizes were in favour of the verum group (as compared to sham). However, confidence intervals and t-tests showed that these differences were not significant.ConclusionThe pilot study demonstrated the feasibility of the acupuncture RCT in persons with increased stress levels. Estimated parameters can be used to design a larger RCT to prove the–here indicated—efficacy of verum acupuncture to decrease stress.Trial registration numberISRCTN15259166.

Reduced tactile acuity in chronic low back pain is linked with structural neuroplasticity in primary somatosensory cortex and is modulated by acupuncture therapy

Prior studies have shown that patients suffering from chronic Low Back Pain (cLBP) have impaired somatosensory processing including reduced tactile acuity, i.e. reduced ability to resolve fine spatial details with the perception of touch. The central mechanism(s) underlying reduced tactile acuity are unknown but may include changes in specific brain circuitries (e.g. neuroplasticity in the primary somatosensory cortex, S1). Furthermore, little is known about the linkage between changes in tactile acuity and the amelioration of cLBP by somatically-directed therapeutic interventions, such as acupuncture. In this longitudinal neuroimaging study, we evaluated healthy control adults (HC, N ​= ​50) and a large sample of cLBP patients (N ​= ​102) with structural brain imaging (T1-weighted MRI for Voxel-Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT) over the lower back (site of pain) and finger (control) locations. Patients were evaluated at baseline and following a 4-week course of acupuncture, with patients randomized to either verum acupuncture, two different forms of sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control. At baseline, cLBP patients demonstrated reduced acuity (greater 2PDT, P ​= ​0.01) over the low back, but not finger (P ​= ​0.29) locations compared to HC, suggesting that chronic pain affects tactile acuity specifically at body regions encoding the experience of clinical pain. At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P ​< ​0.05). GMV in cLBP correlated with greater 2PDT-back scores (ρ ​= ​0.27, P ​= ​0.02). Following verum acupuncture, tactile acuity over the back was improved (reduced 2PDT) and greater improvements were associated with reduced S1-back GMV (ρ ​= ​0.52, P ​= ​0.03) and increased S1-back adjacent white matter FA (ρ ​= ​−0.56, P ​= ​0.01). These associations were not seen for non-verum control interventions. Thus, S1 neuroplasticity in cLBP is linked with deficits in tactile acuity and, following acupuncture therapy, may represent early mechanistic changes in somatosensory processing that track with improved tactile acuity.

Treatment expectations seem to affect bowel health when using acupuncture during radiotherapy for cancer: Secondary outcomes from a clinical randomized sham-controlled trial

ObjectiveTo investigate if frequent stools (“diarrhoea”), infrequent stools (“constipation”), capacity in daily activities and Quality of Life (QoL) differed between patients treated with verum or sham acupuncture, and if patients with more positive treatment expectations differed regarding frequent stools and infrequent stools from patients with less positive treatment expectations. MethodsIn this randomized sham controlled trial, 200 patients received verum traditional penetrating acupuncture or sham acupuncture using a telescopic non-penetrating sham-needle 2–3 times a week during abdominal-pelvic radiotherapy (12 needling sessions during median 5 radiotherapy weeks). The patients registered stool frequency once a week, and registered capacity in daily activities and QoL at the start and end of radiotherapy, and at a one-month follow-up. ResultsIn the verum acupuncture group, 29 of 96 answering patients (30 %) experienced frequent stools and 7 (7 %) experienced infrequent stools at least one week of radiotherapy. In the sham acupuncture group, 21 of 97 (22 %) experienced frequent stools (p = 0.175) and 10 (10 %) experienced infrequent stools (p = 0.613). Patients with low treatment expectancy were more likely than other patients to experience frequent stools (60 % versus 26 %, p = 0.014) but not to experience infrequent stools (25 % versus 12 %, p = 0.334). ConclusionPenetrating acupuncture was not effective for frequent stools or for infrequent stools and did not improve capacity in daily activities or QoL in patients undergoing pelvic-abdominal irradiation for cancer more than non-penetrating acupuncture. Since patients with low acupuncture treatment expectations were more likely to experience frequent stools compared to other patients, non-specific treatment effects warrant further studies.

Chronic Pain Biotypes Predict Differential Analgesic Response to Verum and Sham Acupuncture

Chronic Pain Biotypes Predict Differential Analgesic Response to Verum and Sham Acupuncture

Acupuncture for postprandial distress syndrome: a randomized controlled pilot trial.

Evidence for treating postprandial distress syndrome with acupuncture is limited. We aimed to evaluate the feasibility of verum acupuncture versus sham acupuncture in patients with postprandial distress syndrome. A total of 42 eligible patients were randomly allocated to either verum acupuncture or sham acupuncture groups in a 1:1 ratio. Each patient received 12 sessions over 4 weeks. The primary outcome was the response rate based on the overall treatment effect (OTE) 4 weeks after randomization. Secondary outcomes included dyspepsia symptom severity and adverse events. In each group, 19 patients (91.5%) completed the study. Thirteen patients receiving verum acupuncture and seven patients receiving sham acupuncture were classified as responders according to OTE (61.9% vs 33.3%; rate difference 28.6%; p = 0.06). Dyspepsia symptom severity at the end of treatment also differed significantly between verum acupuncture and sham acupuncture groups (5.9 units vs 3.7 units; between-group difference 2.2 (95% CI, 0.2-4.2); p = 0.04). No serious adverse events occurred. Four weeks of acupuncture may represent a potential treatment for postprandial distress syndrome. The treatment protocol and outcome measures used in this trial were feasible. Since this was a pilot study, the efficacy of acupuncture still needs to be determined by a larger, adequately powered trial.

The selection of dermatomes for sham (placebo) acupuncture points is relevant for the outcome of acupuncture studies: a systematic review of sham (placebo)-controlled randomized acupuncture trials.

Many randomized controlled trials (RCTs) of acupuncture reveal no significant differences between acupuncture and so-called placebo acupuncture. There is a strong tendency to replace the term "placebo" by the term "sham," because any needling stimulates a certain physiological response. However, neither concept accounts for the great diversity of results in RCTs comparing verum acupuncture and sham (placebo) acupuncture. Some trials have shown little or no difference, while other studies have found statistically significant differences. Verum acupuncture and sham (placebo) acupuncture may achieve similar results to the extent that they share active constituents. We identified these common active constituents as dermatomes: the segmental structure of the human body. In our study, we tested the hypothesis that the more verum and sham (placebo) acupuncture share the same dermatomes, the closer the clinical outcomes will be, and vice versa. All major databases were searched for RCTs that tested acupuncture versus sham (placebo) acupuncture. The dermatome charts of Hansen and Schliack were used to verify verum and sham (placebo) needling locations. Reported clinical outcomes were assessed in relation to the percentage of overlap between the dermatomes stimulated by acupuncture and sham (placebo) acupuncture. Our literature search yielded a total of 1738 references. Thirty-four studies met the inclusion criteria. The effects of sham (placebo) acupuncture varied according to the dermatomes stimulated: high overlap with those stimulated by verum acupuncture resulted in almost identical efficacy, while low overlap resulted in significant differences in efficacy. Clinical outcomes were similar when verum acupuncture and sham (placebo) acupuncture shared the same dermatomes (p < 0.01). The findings of this review confirm our hypothesis. Acupuncture studies that employed verum and sham locations on overlapping dermatomes helped to create a mediocre to negative picture of acupuncture's efficacy. The segmental structure of the body with its interconnected reflex system offers an additional neurophysiological explanation for the effectiveness of acupuncture applied to structures segmentally innervated by the spinal and visceral nervous system. Further comparative acupuncture studies should be based on knowledge of segmental anatomy. In testing verum acupuncture versus sham acupuncture, the chosen sham acupuncture needling locations should be situated on non-overlapping dermatomes.

Acupuncture Treatment in Patients with Chronic Subjective Tinnitus: A Prospective, Randomized Study.

Objective: This study investigated the effect, onset, duration of action, and short-term outcomes of acupuncture therapy for treating patients with severe chronic subjective tinnitus. Materials and Methods: This randomized controlled trial evaluated patients with chronic, idiopathic, and severe tinnitus. A total of 105 participants were divided into 2 groups using a randomization method: a study group who received verum acupuncture therapy (n = 53) and a sham acupuncture group (n = 52). Ten acupuncture sessions were given over 5 weeks. After treatment, each participant was monitored for up to 3 months according to changes on a visual analogue Scale (VAS), and Tinnitus Handicap Inventory (THI), and Pure-Tone Audiometry and Speech Discrimination (Interacoustics AC-40, Denmark) scores. Results: The VAS and THI scores were evaluated. A statistically significant difference was noted between the sham and verum acupuncture groups at post-treatment follow-up (P < 0.001). Decreases in the THI and VAS scores became significant in the second week of treatment (P < 0.001 and P < 0.001, respectively), but these scores increased again in the third month post-treatment (P < 0.001 and P < 0.001, respectively). Conclusions: Acupuncture is an effective treatment for patients with severe chronic subjective tinnitus. Patient complaints, decreased beginning at the second treatment week; however, in the third post-treatment month, the complaints reappeared. Maintenance acupuncture therapy is necessary for patients with tinnitus; this approach should be investigated in future studies.

A Multicenter Randomized Controlled Pilot Trial Testing the Efficacy and Safety of Pterygopalatine Fossa Puncture Using One Acupuncture Needle for Moderate-to-Severe Persistent Allergic Rhinitis.

Objective To compare the efficacy and safety of pterygopalatine fossa puncture using one acupuncture needle inserted through the temporal fossa (intervention) and Chinese verum acupuncture (VA) in patients with moderate-to-severe persistent allergic rhinitis. Methods The patients were randomized to an intervention group receiving pterygopalatine fossa puncture with one acupuncture needle for 4 weeks (once or twice weekly, 4–8 sessions in total, with a second course performed if required) or to a control group receiving individualized VA for 4 weeks (twice weekly, eight sessions in total). Patients were followed up 4 weeks later. Results Ninety-six participants were assigned to intervention (n = 48) or VA (n = 48) or VA (P > 0.05 in all cases). Compared with the VA, the time to onset of effect in the intervention group was shorter and the duration of effectiveness was longer. The mean clinical waiting time was significantly shorter in the intervention group than in the control group (6.640 ± 3.035 min and 31.19 ± 10.216 min, respectively). The total number of sessions in the VA group was 384; 7 episodes of subcutaneous bleeding occurred but did not require treatment. The total number of sessions in the intervention group was 185. Two cases of subcutaneous bleeding (one of local hematoma during the intervention and the other one of bruising in the palpebra inferior on the day after intervention) resolved upon withdrawal from the study. Conclusions Pterygopalatine fossa puncture using one acupuncture needle resulted in a shorter time to onset of effect, a longer duration of effectiveness, and less clinical waiting time when compared with VA. Though the significant differences for TNSS and TNNSS were shown within intervention and VA groups, there were no differences between the two groups. Although the rate of subcutaneous bleeding was low, these adverse events may influence patient compliance. This trial is registered with ISRCTN21980724.

Study on the Evaluation of Various Types of Sham Acupuncture Treatments in Hemiplegic Stroke Patients: The Protocol of a Randomized Clinical Trial.

Background Various sham acupuncture devices have been developed and used in studies on acupuncture. However, there is controversy on whether these devices act as an appropriate placebo or control. In particular, validation of sham acupuncture has only been performed in studies involving healthy individuals. In this regard, questions on the suitability of various sham acupuncture treatments in studies involving disease treatment remain unanswered. Therefore, in this study, we would like to investigate the most appropriate sham acupuncture in the research on treatment of hemiplegic stroke. Methods The proposed study is a single-center, prospective, randomized sequence, participant- and assessor-blinded trial with four parallel arms. A total of 90 participants will be randomly assigned to Group 1, Group 2, Group 3, or Group 4 in a 1 : 1 : 1 : 1 ratio. All groups will be treated with Quchi (LI11) for 20 minutes. Group 1 will be treated with verum acupuncture; Group 2, with Park Sham Device; Group 3, with Streitberger's needle; and Group 4, with insertion- and removal-type devices. Participants will undergo one treatment session. The primary outcome is Bang's blinding index. Secondary outcomes are the “Discomfort caused by acupuncture therapy” questionnaire and the Massachusetts General Hospital Acupuncture Sensation Scale index. Immediately after the procedure, all participants will also be monitored for adverse events. Discussion This study will help identify the optimal sham acupuncture device that can be used for clinical studies on acupuncture treatment in hemiplegic stroke patients. This trial is registered with KCT0002622.