Verum Acupuncture Research Articles

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.

The effect and safety of acupuncture as adjunctive therapy for STEMI patients after PCI: study protocol of a randomized controlled trial

BackgroundST-elevation myocardial infarction (STEMI) is a common acute ischemia heart disease that causes serious damage to human health worldwide. Even though morbidity and mortality have significantly decreased by percutaneous coronary intervention (PCI), an additional cardiac protection strategy is still required. Acupuncture therapy has presented a dominant cardiac protection in many studies lately. Thus, we aim to evaluate the effect and safety of acupuncture as an adjunctive therapy in STEMI patients after PCI through a randomized controlled trial.Methods/DesignThis study describes a protocol of multicenter, double-blinded, parallel-controlled, randomized controlled trial. Ninety-six patients with STEMI aged 18–85 years who undergoing PCI will be recruited from the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, The Affiliated Third Hospital of Chengdu Traditional Chinese Medicine University/Chengdu Pidu District Hospital of Traditional Chinese Medicine, and Zhaotong Municipal Hospital of Traditional Chinese Medicine. Participants will be randomly assigned (1:1 ratio) to the verum acupuncture plus basic therapy (i.e., treatment) group or the sham acupuncture plus basic therapy (i.e., control) group. These participants will be treated for 5 days and then will be followed up for 24 weeks. Any adverse events will be recorded throughout the study to evaluate safety.DiscussionThe present study aims to investigate the effect and safety of acupuncture for patients with STEMI after PCI and set up standardized treatment programs for acupuncture of these patients.Trial registrationThis study was registered in the Chinese Clinical Trial Registry (Registration ID: [ChiCTR2400081117]), on February 22, 2024.

Acupuncture for obesity：study protocol for a randomised controlled trial

BackgroundObesity is a major public health issue in China and around the world. While acupuncture is often used in clinical practice, there is a lack of conclusive evidence for its...

The Emotion Regulation of Acupuncture in Chronic Low Back Pain: A Clinical Neuroimaging Protocol.

Acupuncture is effective for patients with chronic low back pain (CLBP), which can relieve pain intensity and regulate negative emotional states such as pain-related anxiety and depression. Previous studies mainly discuss the analgesic mechanism of acupuncture treatment of CLBP, but there are multiple dimensions to pain, including sensation, emotion and cognition. Therefore, this study aims to investigate the central mechanism of acupuncture for CLBP from the perspective of emotional regulation by functional magnetic resonance imaging (fMRI). A total of 72 patients with CLBP will be recruited in the study and randomly assigned to the verum acupuncture group or the sham acupuncture group. The trail will last for 18 weeks including a 2-week baseline, a 4-week treatment and a 12-week for follow-up period. The primary outcomes are the visual analog scale (VAS) and the Japanese Orthopaedic Association Scores (JOA) score. The secondary outcomes are the 12-item short form health survey (SF-12), the state trait anxiety inventory (STAI), the self-rating anxiety scale (SAS) and self-rating depression scale (SDS). The VAS, JOA, STAI SAS and SDS will be collected at baseline, week 2, week 4, and after follow-up. The SF-12 will be evaluated at baseline, week 2 and week 4. Functional magnetic resonance imaging (MRI) data will be collected at baseline and the end of treatment. Emotion-related brain regions will be chosen as regions of interest (ROIs). The gray matter volume (GMV), amplitude of low-frequency fluctuation (ALFF), regional homogeneity (ReHo), functional connectivity (FC), and large-scale functional brain network based on these ROIs will be analyzed within and between the two groups. This study will verify the emotional regulation of acupuncture and explore the mechanism of acupuncture for emotion regulation in patients with CLBP. https://www.chictr.org.cn/showproj.html?proj=195486, identifier: ChiCTR2300070557.

Validation of a New Sham Acupuncture Needle for Double-Blind Trials: A Study Protocol

Background: To establish efficacy in acupuncture treatment, rigorous randomized controlled trials (RCT) are needed. Non-invasive sham acupuncture needles are an effective tool for practitioner/participant blinding. This study presents a protocol for the validation of a newly developed sham acupuncture needle.Methods: A double-blind RCT will be conducted on 66 healthy adults who will be randomly assigned (using computer-generated random numbers) to either the verum (<i>n</i> = 33) or sham (<i>n</i> = 33) acupuncture needle group. The needles will be inserted at 2 acupuncture points: LI4 (upper limb) and ST36 (lower limb). The primary outcome measure is the practitioner/participants belief that they received verum or sham acupuncture. The secondary outcome measures are participant-rated sensations (penetration, pain, and de qi). Adverse events will be recorded with detailed explanations, categorizing occurrences according to related or unrelated to acupuncture. As the newly developed sham acupuncture has not been studied before, an exploratory approach has been adopted. Descriptive statistics, t test, and χ² test will be applied appropriately.Results: This study is intended to provide a protocol for the validation of a sham acupuncture needle by using a double-blind RCT setting, and the results will hopefully contribute to the standardization of the needles used for sham acupuncture. The outcomes aim to determine the reliability of practitioner/participant blinding, participant experience of sensations, and lay groundwork for a standardized control group for clinical trials in the future. The newly developed non-invasive sham acupuncture needle may reduce bias and improve reliability in the size effect of acupuncture treatment.

Acupuncture for Combat-Related Posttraumatic Stress Disorder

Current interventions for posttraumatic stress disorder (PTSD) are efficacious, yet effectiveness may be limited by adverse effects and high withdrawal rates. Acupuncture is an emerging intervention with positive preliminary data for PTSD. To compare verum acupuncture with sham acupuncture (minimal needling) on clinical and physiological outcomes. This was a 2-arm, parallel-group, prospective blinded randomized clinical trial hypothesizing superiority of verum to sham acupuncture. The study was conducted at a single outpatient-based site, the Tibor Rubin VA Medical Center in Long Beach, California, with recruitment from April 2018 to May 2022, followed by a 15-week treatment period. Following exclusion for characteristics that are known PTSD treatment confounds, might affect biological assessment, indicate past nonadherence or treatment resistance, or indicate risk of harm, 93 treatment-seeking combat veterans with PTSD aged 18 to 55 years were allocated to group by adaptive randomization and 71 participants completed the intervention protocols. Verum and sham were provided as 1-hour sessions, twice weekly, and participants were given 15 weeks to complete up to 24 sessions. The primary outcome was pretreatment to posttreatment change in PTSD symptom severity on the Clinician-Administered PTSD Scale-5 (CAPS-5). The secondary outcome was pretreatment to posttreatment change in fear-conditioned extinction, assessed by fear-potentiated startle response. Outcomes were assessed at pretreatment, midtreatment, and posttreatment. General linear models comparing within- and between-group were analyzed in both intention-to-treat (ITT) and treatment-completed models. A total of 85 male and 8 female veterans (mean [SD] age, 39.2 [8.5] years) were randomized. There was a large treatment effect of verum (Cohen d, 1.17), a moderate effect of sham (d, 0.67), and a moderate between-group effect favoring verum (mean [SD] Δ, 7.1 [11.8]; t90 = 2.87, d, 0.63; P = .005) in the intention-to-treat analysis. The effect pattern was similar in the treatment-completed analysis: verum d, 1.53; sham d, 0.86; between-group mean (SD) Δ, 7.4 (11.7); t69 = 2.64; d, 0.63; P = .01). There was a significant pretreatment to posttreatment reduction of fear-potentiated startle during extinction (ie, better fear extinction) in the verum but not the sham group and a significant correlation (r = 0.31) between symptom reduction and fear extinction. Withdrawal rates were low. The acupuncture intervention used in this study was clinically efficacious and favorably affected the psychobiology of PTSD in combat veterans. These data build on extant literature and suggest that clinical implementation of acupuncture for PTSD, along with further research about comparative efficacy, durability, and mechanisms of effects, is warranted. ClinicalTrials.gov Identifier: NCT02869646.

The effect of sham acupuncture can differ depending on the points needled in knee osteoarthritis: A systematic review and network meta-analysis

ObjectiveIn sham acupuncture-controlled acupuncture clinical trials, although sham acupuncture techniques are different from those of verum acupuncture, the same acupuncture points are often used for verum and sham acupuncture, raising the question of whether sham acupuncture is an appropriate placebo. We aimed to examine the effects of sham and verum acupuncture according to the points needled (same or different between verum and sham acupuncture) in knee osteoarthritis. MethodsTen databases were searched to find randomized controlled clinical trials (RCTs) assessing the effects of verum acupuncture with sham acupuncture or waiting lists on knee osteoarthritis. Sham acupuncture was classified as using the same acupuncture points as those in verum acupuncture (SATV) or using sham points (SATS). A frequentist network meta-analysis (NMA) was conducted, and the certainty of evidence was evaluated. ResultsA total of 10 RCTs involving 1628 participants were included. Verum acupuncture was significantly superior to SATS but not different from SATV in terms of pain reduction. Additionally, SATV was significantly superior to the waiting list. For physical function, no difference were found between verum acupuncture, SATV, and SATS. The certainty of evidence was low to moderate. ConclusionFor knee osteoarthritis, the pain reduction effect of acupuncture may differ according to the needling points of sham acupuncture, and the control group should be established according to the specific aim of the study design and treatment mechanism.

Different Outcomes According to Needling Point Location Used in Sham Acupuncture for Cancer-Related Pain: A Systematic Review and Network Meta-Analysis.

Numerous acupuncture studies have been conducted on cancer-related pain; however, its efficacy compared to sham acupuncture remains controversial. We confirmed whether the outcome of acupuncture differs according to the needling points of sham acupuncture for cancer-related pain. We searched 10 databases on 23 May 2023 to screen acupuncture trials using sham acupuncture or waiting list as controls for cancer-related pain. Sham acupuncture was classified into two types, depending on whether the needling was applied at the same locations as verum acupuncture (SATV) or not (SATS). A network meta-analysis (NMA) was performed on the basis of a frequentist approach to assess pain severity. Eight studies (n = 574 participants) were included in the review, seven of which (n = 527 participants) were included in the NMA. The pain severity was not significantly different between SATV and verum acupuncture, but verum acupuncture significantly improved pain severity compared to SATS. The risk of bias affecting the comparisons between the verum and sham acupuncture was generally low. Previous acupuncture trials for cancer-related pain showed differing outcomes of sham and verum acupuncture, depending on the needling points of sham acupuncture. The application of SATV cannot be considered a true placebo, which leads to an underestimation of the efficacy of verum acupuncture.

Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial

BackgroundHot flashes are the common and debilitating symptom among prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that pharmacological option such as venlafaxine provides partial relief, but the tolerability is poor when dose is not tapered. Hence, alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence.MethodsFive hospitals will recruit 120 acupuncture naïve patients with moderate-to-severe hot flashes after prostate cancer received ADT in China from February 2023 to December 2024. Participants will be randomly 2:1:1 allocated to the 18 sessions of verum acupuncture at true acupuncture points plus usual care, 18 sessions of non-penetrating sham acupuncture at non-acupuncture points plus usual care, or usual care alone over 6 weeks. The primary outcome measure is the change of mean weekly hot flashes symptom severity score (HFSSS) at the end of treatment compared with baseline.Expected Results and ConclusionWe will be able to measure the effectiveness of acupuncture for patients with PCa suffering from ADT-induced hot flashes and whether acupuncture is superior to sham acupuncture and usual care. The proposed acupuncture treatment might provide an alternative option for those patients.Trial RegistrationClinicaltrials.gov (NCT05069467).

Effect of acupuncture for patients with knee osteoarthritis: study protocol for a double-dummy randomized controlled trial

BackgroundAcupuncture has been used to relieve chronic pain in patients with knee osteoarthritis (KOA), but the evidence is contradictory. Therefore, we carefully designed a double-dummy randomized controlled trial (RCT) to explore the therapeutic effect of acupuncture for KOA.Methods/designA total of 138 eligible participants with KOA who consent to participate will be randomly divided into Groups A, B, and C in a ratio of 1:1:1. Participants in Group A will receive verum acupuncture and placebo gel, while those in Groups B and C will be treated with diclofenac diethylammon gel and sham acupuncture, sham acupuncture and placebo gel, respectively. The patients will receive 4 weeks of treatment, five times a week, including acupuncture treatment once a day for 30 min and gel treatment three times a day. The primary outcome will be the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at week 4. The secondary outcomes will include visual analog scale (VAS), Arthritis Quality of Life Measurement Scale Simplified Scale (AIMS2-SF), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Credibility/Expectancy Questionnaire. The evaluation will be performed at baseline, week 4, 8, and 12 after randomization.DiscussionThis double-dummy RCT used diclofenac diethylammon gel as a positive control, and the completion of this trial will provide detailed and accurate evidence of the efficacy and safety of acupuncture for KOA.Trial registration: China Clinical Trials Registry No.ChiCTR2100043947. Registered on September 24, 2020. https://www.chictr.org.cn/showproj.html?proj=122536.

Effectiveness of Acupuncture on Health-Related Quality of Life in Patients Receiving Maintenance Hemodialysis.

Patients with kidney failure (KF) receiving maintenance hemodialysis (HD) experience numerous symptoms that impair their health-related quality of life (HRQOL) and contribute to high mortality rates. Acupuncture is often used for symptom enhancement and HRQOL. This blinded, randomized, controlled patient-assessor trial evaluated the effectiveness of acupuncture compared with sham acupuncture on patients' HRQOL receiving maintenance HD as a secondary analysis. Seventy-two participants were randomly assigned to verum acupuncture (VA), sham acupuncture (SA), or waiting-list (WL) groups. The outcome was an improvement in HRQOL, assessed using the Kidney Disease Quality of Life-Short Form, version 1.3 (KDQOL-SF™ v1.3) at baseline, after treatment, and at 12-week follow-up. Non-parametric tests were used for statistical analysis. Of the 72 randomized patients, 67 were included in the complete analysis set. As for the changes between baseline and after treatment, the VA group showed significantly increased scores on most of the KDQOL-SF™ v1.3 scales compared to SA or WL groups (p < 0.05). No statistically significant differences between groups were observed in the changes from baseline to follow-up (p > 0.05). Compared to the sham treatment, acupuncture improved the HRQOL in patients receiving maintenance HD after treatment but not at follow-up.

Modulation effects of different treatments on periaqueductal gray resting state functional connectivity in knee osteoarthritis knee pain patients.

The analgesic effect of acupuncture is widely recognized, but the mechanical characteristics of acupuncture for pain relief, compared to non-steroidal anti-inflammatory (NSAIDs) and placebo medication, remain unknown. To compare the modulation effects of acupuncture treatment with NSAIDs and placebo medication on descending pain modulation system (DPMS) in knee osteoarthritis (KOA) patients. This study recruited 180 KOA patients with knee pain and 41 healthy controls (HCs). Individuals with KOA knee pain were divided randomly into groups of verum acupuncture (VA), sham acupuncture (SA), celecoxib (SC), placebo (PB), and waiting list (WT), with 36 patients in each group. VA and SA groups included ten sessions of puncturing acupoints or puncturing non-acupoints acupuncture treatment for two successive weeks. Celecoxib capsules were continuously given orally to patients in the SC group at a dosage of 200 mg daily for 2 weeks. In the PB group, patients received a placebo capsule once a day for 2 weeks at the same dosage as celecoxib capsules. In the WL group, patients did not receive any treatment. Patients underwent a resting-state BOLD-fMRI scan pre- and post-receiving the therapy, whereas HCs only underwent a baseline scan. Seed (ventrolateral periaqueductal gray, vlPAG, a key node in DPMS) based resting-state functional connectivity (rs-FC) was applied in the data analysis. All groups demonstrated improved knee pain scores relative to the initial state. There was no statistical difference between the VA and SA groups in all clinical outcomes, and vlPAG rs-FC alterations. KOA knee pain individuals reported higher vlPAG rs-FC in the bilateral thalamus than HCs. KOA knee pain patients in the acupuncture group (verum + sham, AG) exhibited increased vlPAG rs-FC with the right dorsolateral prefrontal cortex (DLPFC) and the right angular, which is associated with knee pain improvement. In contrast with the SC and PB group, the AG exhibited significantly increased vlPAG rs-FC with the right DLPFC and angular. Contrary to the WT group, the AG showed greater vlPAG rs-FC with the right DLPFC and precuneus. Acupuncture treatment, celecoxib, and placebo medication have different modulation effects on vlPAG DPMS in KOA knee pain patients. Acupuncture could modulate vlPAG rs-FC with brain regions associated with cognitive control, attention, and reappraisal for knee pain relief in KOA patients, compared with celecoxib and placebo medication.

Can Acupuncture Improve the Flexibility of Hamstring Muscles? A Randomized, Blinded, and Controlled Pilot Study.

(1) Background: The lack of flexibility is frequently reported as a risk factor for hamstring muscle damage. Acupuncture, a therapeutic tool of traditional Chinese medicine (TCM), may play a role in both treatment and prevention by improving muscle strength, microcirculation, and reducing muscle soreness. The primary objective of this pilot study was to examine the immediate effects of acupuncture on hamstring muscle stretching and on the pain or discomfort reported during stretching. (2) Methods: To mitigate heterogeneity effects, and due to the small sample size, the study employed a crossover design in which each participant was tested at three different moments of the experimental period with verum (true acupuncture in selected acupoints), sham (fake acupuncture in zones of the skin not corresponding to any known acupoint but near the selected acupoints), and placebo (stimulation of the selected acupoints with a stainless steel wire and cannula, without puncturing) stimulations. Flexibility and pain or discomfort were assessed using the seat and reach test (SR) and a visual analogic scale (VAS). (3) Results: Significant changes in flexibility were observed after verum acupuncture (p = 0.03), while no significant changes were seen in sham and placebo (p = 0.86 and p = 0.18, respectively). No significant differences were found in pain or discomfort during any of the stimulations (verum, p = 0.55; sham, p = 0.50; placebo, p = 0.58). (4) Conclusions: The results of this pilot study suggest that acupuncture may improve flexibility in the hamstring muscles, though it does not significantly affect pain or discomfort during stretching.

Sham Acupuncture Is Not Just a Placebo.

Sham acupuncture should have two distinct features: first, it must be morphologically similar to verum acupuncture for blinding purposes, and second, it must not exert physiologically expected effects of verum acupuncture. While several types of sham acupuncture are currently used, there are on-going debates on which sham acupuncture can meet the criteria for being an appropriate control intervention in acupuncture research. In view of this situation, it is unreasonable to regard the use of sham acupuncture in acupuncture research as the same as the use of placebo drugs in drug research. Given the current research evidence that sham acupuncture can exert not only the originally expected non-specific effects but also sham acupuncture-specific effects, it would be misleading to simply regard sham acupuncture as the same as placebo. Therefore, researchers should be cautious when using the term sham acupuncture in clinical investigations.

The increased inter-brain neural synchronization in prefrontal cortex between simulated patient and acupuncturist during acupuncture stimulation: Evidence from functional near-infrared spectroscopy hyperscanning.

The patient-acupuncturist interaction was a critical influencing factor for acupuncture effects but its mechanism remains unclear. This study aimed to examine the inter-brain mechanism of patient-acupuncturist dyad during acupuncture stimulation in a naturalistic clinical setting. Seventy healthy subjects (simulated "patients") were randomly assigned to two groups and received verum acupuncture group or sham acupuncture by one acupuncturist. Functional near-infrared spectroscopy hyperscanning was used to simultaneously record the neural responses of "patient"-acupuncturist dyad during acupuncture stimulation in each group. The results showed that inter-brain neural synchronization (INS) in the prefrontal cortex (PFC) of "patient"-acupuncturist dyad was significantly increased during verum but not sham acupuncture stimuli, and positively correlated with the needling sensations of "patients." Granger causality analysis demonstrated that there were no significant differences in INS direction between the "patient" and the acupuncturist. This study identified the increase of INS between "patient" and acupuncturist, and suggested that PFC was important to the interaction of "patient"-acupuncturist dyad.

Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Study Protocol for a Randomized Controlled Trial.

The proposed randomized controlled trial protocol will evaluate the effect of acupuncture treatment on the functional capacity (FC) and health-related quality of life (HRQOL) in chronic kidney disease (CKD) with glomerular filtration rate (GFR) category 5 (CKG G5) patients receiving maintenance dialysis. Patients undergoing hemodialysis (HD) from a dialysis center will be randomly assigned to experimental, placebo and control groups. In order to determine the difference between the same number of treatments performed three times or one treatment a week, experimental (verum acupuncture) and placebo (sham acupuncture) groups will receive a total of nine acupuncture treatments; however, both groups will be divided into subgroups A and B. The same selection of acupuncture points will be applied to both experimental subgroups and the placebo subgroups will receive acupuncture on non-acupuncture points. The results will be assessed by the 6-min Walk Test, Handgrip Test, 30-sec Sit-to-Stand and Kidney Disease Quality of Life-Short Form and will be held at baseline, after treatment and 12 weeks post-treatment follow up. This paper describes the rationale and design for a randomized, patient-assessor blinded controlled trial, which may provide evidence for the clinical application of acupuncture in CKG G5 patients undergoing HD.

Acupuncture modulates the frequency-specific functional connectivity density in primary dysmenorrhea.

BackgroundThe study aimed to investigate how acupuncture modulates brain activities across multiple frequency bands to achieve therapeutic effects in PDM.MethodsA total of 47 patients with PDM were randomly assigned to the verum acupuncture group and sham acupuncture group with three menstrual cycles of the acupuncture course. The fMRI scans, visual analog scale (VAS) scores, and other clinical evaluations were assessed at baseline and after three menstrual-cycles treatments. The global functional connectivity density (gFCD) analyses were performed between the pre-and post-acupuncture course of two groups at full-low frequency band, Slow-3 band, Slow-4 band, and Slow-5 band.ResultsAfter the acupuncture treatments, the patients with PDM in the verum acupuncture group showed significantly decreased VAS scores (p < 0.05). The frequency-dependent gFCD alternations were found in the verum acupuncture group, altered regions including DLPFC, somatosensory cortex, anterior cingulate cortex (ACC), middle cingulate cortex (MCC), precuneus, hippocampus, and insula. The sham acupuncture modulated regions including angular gyrus, inferior frontal gyrus, and hippocampus. The gFCD alternation in DLPFC at the Slow-5 band was negatively in the patients with PDM following verum acupuncture, and S2 at the Slow-4 band was positively correlated with VAS scores.ConclusionThese findings supported that verum acupuncture could effectively modulate frequency-dependent gFCD in PDM by influencing abnormal DLPFC at Slow-5 band and hippocampus at the Slow-3 band. The outcome of this study may shed light on enhancing the potency of acupuncture in clinical practice.

Effect of Acupuncture on the Cognitive Control Network of Patients with Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial.

PurposeAbnormal central nervous system function is the key central pathological factor leading to chronic pain in patients with knee osteoarthritis (KOA). Acupuncture can effectively relieve the pain of KOA patients. However, the central nervous mechanism of acupuncture treating KOA is not fully understood. This trial will use functional magnetic resonance imaging (fMRI) analysis techniques to investigate the potential central nervous mechanism of acupuncture treatment of KOA.Materials and MethodsA total of 108 patients will be randomized (in a 1:1:1 ratio) into three groups, this trial will include 4-week treatment, patients in groups A and B will receive 20 acupuncture and sham acupuncture sessions, respectively, patients in group C will not receive any intervention, and all patients will receive fMRI scans before and after the intervention. The Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) will be the primary clinical outcome. Then, we will explore the functional changes of the cognitive control network (CCN) in the brains of KOA patients through whole brain functional connectivity (FC) analysis and seed-based functional connectivity (sFC) analysis. Pearson correlation coefficient will be used to analyze the relationship between the improved value of the clinical correlation scale and the change of fMRI data.DiscussionThis trial will analyze the efficacy of verum acupuncture, sham acupuncture and the waiting-list for KOA and explore the activity of the CCN in three groups of patients by fMRI, so as to reveal the central nervous mechanisms of acupuncture in the treatment of KOA.Study RegistrationThis study is approved by the Ethics Committee of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine (No: 2019HL-133-01) and registered in the Chinese Clinical Trial Registry, ChiCTR2000038554.

A Bibliometric of Trends on Acupuncture Research About Migraine: Quantitative and Qualitative Analyses.

IntroductionMigraine is a common neurovascular disorder disease often characterized by episodic headaches that can develop chronic disorders. Acupuncture as a non-pharmacological therapy has been extensively used to manage migraine prevention and treatment in clinical practice. Many studies focused on acupuncture therapy for migraine, but none analyzed the publications quantitatively and qualitatively. The aim of this study is to show the recent researches and trend of advances in this field based on quantitative and qualitative analyses.MethodsPublications related to acupuncture research about migraine were retrieved from the Web of Science (WoS) Core Collection and Scopus database. The quantitative data analysis was performed to show the recent researches and trend of advances from six perspectives: annual scientific production, countries, institutions, authors, journals, and keywords. For the qualitative analysis, acupuncture research about migraine was analyzed from the top twenty most highly cited articles.ResultsThe number of annual scientific production steadily increased with some fluctuations over the years. The country and institutions contributing most to this field are China and Chengdu University of Traditional Chinese Medicine. Zhao Ling was the most relevant author in this field, Linde Klaus was the highly co-cited author. The leading journal regarding the number of selected articles was “Zhongguo Zhen Jiu”. The top twenty most highly cited articles were divided into two categories: original articles and reviews. Among these two categories, original articles occupied the vast majority. Moreover, the real effectiveness of acupuncture for migraine prevention and treatment was the research frontier and hot spot.ConclusionResults of our analysis indicate that the number of publications showed an overall increasing trend, demonstrating that this research field still has a promising future. In addition, more researchers will probably focus their work on the difference between verum acupuncture and usual care for preventing and treating migraine.

Acupuncture for insomnia after ischemic stroke: an assessor-participant blinded, randomized controlled trial.

To date, there has been little focus on research into acupuncture for insomnia after ischemic stroke. Insomnia is one of the most common sequelae after ischemic stroke, and it is the most unrecognized modifiable risk factor. To evaluate the efficacy and safety of acupuncture for insomnia after ischemic stroke. In this assessor-participant blinded, randomized, controlled trial, 144 ischemic stroke patients with insomnia meeting Diagnostic and Statistical Manual of Mental Disorders (fifth edition, DSM-5) criteria were assigned to verum or sham acupuncture treatment (n = 72 per group) for three sessions per week over 4 weeks. The outcomes were the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), stroke-specific quality of life (SSQoL), and Hospital Anxiety and Depression Scale (HADS) scores. Multiple objective sleep variables were recorded using actigraphy. Assessment was conducted at baseline, and thereafter once biweekly for the 4-week treatment and at 4 weeks of follow-up. The verum acupuncture group had significantly greater improvements than the sham acupuncture group in sleep quality from 2 weeks into treatment throughout the follow-up, indicated by ISI scores and actigraphic variable SE (sleep efficiency). This greater improvement was also observed in the PSQI after 4 weeks of treatment throughout follow-up, as well as actigraphic variable TST (total sleep time), SSQoL and HADS scores at the end of treatment, and SSQoL and depression scores at follow-up. There was no significant difference between groups in the actigraphic variable SA (sleep awakenings). Adverse events were mild in severity, and their incidence was not significantly different between the two groups. Acupuncture appears to be efficacious, in terms of improving insomnia, related quality of life, and affective symptoms, for patients with ischemic stroke. ChiCTR-IIC-16008382 (Chinese Clinical Trial Registry).