Humans ; Endoscopic Ultrasound-Guided Fine Needle Aspiration ; Pancreatic Neoplasms ; Pancreas ; Needles

From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.
Needles ; Endoscopy ; Injections ; Risk Management ; Industry

OBJECTIVE: This study aims to clarify how the stimulation of acupuncture points is achieved by needles with different surface texture during acupuncture; it also seeks to lessen injury at the insertion site and increase the therapeutic efficacy of acupuncture, by simulating the mechanical effects of various needle surface patterns on Zusanli (ST36) without changing the radius of acupuncture needles. METHODS: Five acupuncture needle models with different surface patterns, including the smooth needle, the lined needle, the ringed needle, the left-hand threaded needle and the right-hand threaded needle, and a layered model of the Zusanli acupoint were used to investigate how to reduce tissue damage and increase stimulation during acupuncture treatment. Puncturing of the skin as well as lifting-inserting and twisting needle manipulations were simulated using these models, and the degree of damage and force of stimulation caused by the acupuncture needles with different surface patterns during acupuncture were compared. RESULTS: The smooth needle and the lined needle caused the least tissue damage during insertion, while the left-hand threaded and the right-hand threaded needles caused the most damage. The ringed needle, the left-hand threaded needle and the right-hand threaded needle stimulated the acupoint tissue more during lifting-inserting manipulations, while the lined needle and the smooth needle produced less stimulation. The stimulation of the lined needle on the acupoint tissue was the largest during twisting manipulation, whereas the left-hand threaded needle and the right-hand threaded needle had smaller effects. In lifting-inserting and twisting manipulations, both the left-hand threaded needle and right-hand threaded needle provided more stimulation, but the torsion direction in which they produced better stimulation was the opposite. CONCLUSION According to the simulation results, the ringed pattern enhances stimulation best in the lifting-inserting manipulation, whereas the lined pattern enhances stimulation best in the twisting manipulation. Both the right-hand and left-hand thread patterns have certain enhancing effects in these two operations. Taking the geometric properties of the pattern into account, the left-hand thread pattern and the right-hand thread pattern have the geometric characteristics of both the lined pattern and the ringed pattern. To conclude, a pattern perpendicular to the movement direction during the acupuncture manipulation creates more stimulation. These results have significance for future needle design. Please cite this article as: Sun MZ, Wang X, Li YC, Yao W, Gu W. Mechanical effects of needle texture on acupoint tissue. J Integr Med. 2023; 21(3): 254-267.
Acupuncture Points ; Needles ; Acupuncture Therapy/methods* ; Hand

OBJECTIVE: To observe the effect of standardized Jin's three-needle therapy on limb motor function and nerve function defect in stroke patients, and to evaluate the placebo control method. METHODS: A total of 66 patients with stroke were randomly divided into a Jin's three-needle group (33 cases, 3 cases dropped off) and a placebo needle group (33 cases, 4 cases dropped off). All the patients were treated with conventional medication and rehabilitation treatment. In addition, the patients in the Jin's three-needle group were treated with standardized Jin's three-needle therapy at temporal three points, spirit four points, hand three points, foot three points, upper extremity spasm three points, lower extremity spasm three points, etc.; while the patients in the placebo needle group were treated with placebo needling at identical points. All the treatments were given once a day, 5 days a week, and 3-week treatment was given with an interval of 2 days between weeks. The scores of Fugl-Meyer assessment scale (FMA) and National Institutes of Health stroke scale (NIHSS) were observed before treatment, 10 d and 21 d into treatment, and the blind evaluation was conducted after treatment. RESULTS: On the 10 d and 21 d into treatment, the FMA scores in both groups were higher than those before treatment (P<0.01), and the NIHSS scores were lower than those before treatment (P<0.01). On the 10 d and 21 d into treatment, the FMA scores in the Jin's three-needle group were higher than those in the placebo needle group (P<0.05); on the 10 d into treatment, the NIHSS score in the Jin's three-needle group was were lower than that in the placebo needle group (P<0.05). There was no significant difference between the two groups on judging the type of treatment (P>0.05), and the consistency with the real situation was poor (Cohen's kappa coefficient<0.20). CONCLUSION The standardized Jin's three-needle therapy could effectively improve the limb motor function and nerve function defect in stroke patients. The placebo control method used in this study shows good clinical operability and masking effect.
Humans ; Acupuncture Therapy/methods* ; Acupuncture Points ; Stroke/therapy* ; Lower Extremity ; Needles ; Treatment Outcome ; Stroke Rehabilitation

The appropriate needle device is crucial for obtaining the curative effect of fire needling therapy. The article introduces the material specification, clinical operation, indications, characteristics and advantages of the contemporary traditional fire needling devices (e.g. He's fire needle and Shi 's fire needle) and the contemporary new-type ones (e.g. fire needling with filiform needle and micro-needle); and determines the innovations of modern fire needling. It is anticipated that the needle specifications, production process and operation standard of fire needling devices should be further unified so as to provide the references for the selection of fire needling devices in treatment based on clinical syndrome differentiation and expand the clinical application of fire needling therapy.
Humans ; Male ; Acupuncture Points ; Acupuncture Therapy ; Needles

OBJECTIVE: To compare the effect on facial acupoint temperature between acupuncture at Houxi (SI 3) and Dazhui (GV 14) so as to verify "Houxi (SI 3) communicating the governor vessel" based on the infrared thermal imaging technology. METHODS: Thirty-five healthy subjects (5 cases dropped off) were collected and before-after study in the same subject was adopted. The subjects were successively assigned into a sham-acupuncture group, a Houxi group, a Wangu group and a Dazhui group. Sham-acupuncture at Houxi (SI 3) on the left, acupuncture at Houxi (SI 3) on the left, Wangu (SI 4) on the left and Dazhui (GV 14) were given respectively. One intervention was given and the needles were retained for 30 min in each group. 30 min before and after acupuncture, the infrared thermal images of the face were collected, and the facial temperature was compared among the following 5 acupoints, i.e. Yintang (GV 24⁺), Suliao (GV 25), Shuigou (GV 26), Duiduan (GV 27) and Chengjiang (CV 24). RESULTS: After acupuncture, the facial temperature at Yintang (GV 24⁺) and Chengjiang (CV 24) was increased compared before acupuncture in the sham-acupuncture group (P<0.01, P<0.05). The facial temperature at Suliao (GV 25) in the Houxi group was reduced after acupuncture (P<0.05). In the Wangu group, the temperature at Yintang (GV 24⁺) was increased compared before acupuncture (P<0.01). The facial temperature was increased at Duiduan (GV 27) and Chengjiang (CV 24) compared before acupuncture in the Dazhui group (P<0.01, P<0.05). The differences of facial temperature at Chengjiang (CV 24) and Suliao (GV 25) after acupuncture were larger than before acupuncture in the Houxi group and the Dazhui group (P<0.01). In comparison with the temperature at Suliao (GV 25) of the same group, the differences of facial temperature before and after acupuncture at Yintang (GV 24⁺), Shuigou (GV 26), Duiduan (GV 27) and Chengjiang (CV 24) were increased in the Houxi group (P<0.01, P<0.05); while, the increase was also obtained at Yintang (GV 24⁺), Shuigou (GV 26), Duiduan (GV 27) and Chengjiang (CV 24) in the Dazhui group (P<0.05, P<0.01). The difference of facial temperature at Yintang (GV 24⁺) before and after acupuncture was increased compared with Suliao (GV 25) in the Wangu group (P<0.05). CONCLUSION Acupuncture at Houxi (SI 3) generates a similar thermal effect as Dazhui (GV 14). It regulates and dissipates the core temperature to "govern the yang qi of the whole body".
Humans ; Acupuncture Therapy ; Acupuncture Points ; Healthy Volunteers ; Needles ; Technology

The cases of feeling comfort during acupuncture and moxibustion treatment in literature were summarized and its biological basis was explored. A simple classification of comfort was made, and the importance of obtaining comfort in acupuncture treatment was pointed out. Considering the pursuit of less pain and harmlessness in modern clinical treatment, sugar needle should be advocated and popularized in current clinical practice of acupuncture and moxibustion.
Sugars ; Moxibustion ; Acupuncture Therapy ; Emotions ; Needles

Rheumatoid arthritis(RA) is a chronic degenerative joint disease characterized by inflammation. Due to the complex causes, no specific therapy is available. Non-steroidal anti-inflammatory agents and corticosteroids are often used(long-term, oral/injection) to interfere with related pathways for reducing inflammatory response and delaying the progression of RA, which, however, induce many side effects. Microneedle, an emerging transdermal drug delivery system, is painless and less invasive and improves drug permeability. Thus, it is widely used in the treatment of RA and is expected to be a new strategy in clinical treatment. This paper summarized the application of microneedles in the treatment of RA, providing a reference for the development of new microneedles and the expansion of its clinical application.
Humans ; Drug Delivery Systems ; Administration, Cutaneous ; Pharmaceutical Preparations ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use* ; Arthritis, Rheumatoid/drug therapy* ; Needles

Deep venipuncture catheterization is a routine and basic operation in the treatment of critically ill patients, and it is the most effective way to quickly correct the shock. Clinical B-ultrasound guided deep vein catheters can improve the success rate of puncture, but in the process of operation, the short axis needs to be replaced by the long axis. In the replacement process, the stability of the novice is insufficient, the positioning is difficult, and the operation time is too long. If only short axis puncture is used, it is impossible to know whether the current position of the puncture needle, and the puncture may be too deep and stray into the artery. The accuracy of the 45 degree angle of the injection point requires a very experienced operator. In view of the above shortcomings, doctors in the department of critical care medicine of Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine designed a B-ultrasound puncture equipment, which has obtained the National Invention Patent of China (ZL 2016 1 0571557.X). The device is composed of B-ultrasound probe fixing frame, sliding scale plate, simulation slide rule, puncture needle, sliding device. By sliding device the angle of the pinhole channel, it is conducive to the accurate positioning of the puncture target, optimizing the operation procedure, improving the puncture speed and accuracy, effectively reducing the occurrence of puncture complications, ensuring patient safety, reducing unnecessary waste of human and material resources. It can reduce the workload of medical staff and is worthy of clinical practice.
Humans ; Catheterization, Central Venous/methods* ; Ultrasonography, Interventional/methods* ; Ultrasonography ; Punctures/methods* ; Needles

BACKGROUND: The placebo response of sham acupuncture in patients with primary dysmenorrhea is a substantial factor associated with analgesia. However, the magnitude of the placebo response is unclear. OBJECTIVE: This meta-analysis assessed the effects of sham acupuncture in patients with primary dysmenorrhea and the factors contributing to these effects. SEARCH STRATEGY: PubMed, Embase, Web of Science, and Cochrane CENTRAL databases were searched from inception up to August 20, 2022. INCLUSION CRITERIA: Randomized controlled trials (RCTs) using sham acupuncture as a control for female patients of reproductive age with primary dysmenorrhea were included. DATA EXTRACTION AND ANALYSIS: Pain intensity, retrospective symptom scale, and health-related quality of life were outcome measures used in these trials. Placebo response was defined as the change in the outcome of interest from baseline to endpoint. We used standardized mean difference (SMD) to estimate the effect size of the placebo response. RESULTS: Thirteen RCTs were included. The pooled placebo response size for pain intensity was the largest (SMD = -0.99; 95% confidence interval [CI], -1.31 to -0.68), followed by the retrospective symptom scale (Total frequency rating score: SMD = -0.20; 95% CI, -0.80 to -0.39. Average severity score: SMD = -0.35; 95% CI, -0.90 to -0.20) and physical component of SF-36 (SMD = 0.27; 95% CI, -0.17 to 0.72). Studies using blunt-tip needles, single-center trials, studies with a low risk of bias, studies in which patients had a longer disease course, studies in which clinicians had < 5 years of experience, and trials conducted outside Asia were more likely to have a lower placebo response. CONCLUSION Strong placebo response and some relative factors were found in patients with primary dysmenorrhea. PROSPERO registration number: CRD42022304215. Please cite this article as: Sun CY, Xiong ZY, Sun CY, Ma PH, Liu XY, Sun CY, Xin ZY, Liu BY, Liu CZ, Yan SY. Placebo response of sham acupuncture in patients with primary dysmenorrhea: A meta-analysis. J Integr Med. 2023; 21(5): 455-463.
Female ; Humans ; Dysmenorrhea/therapy* ; Acupuncture Therapy ; Pain Management ; Needles ; Placebo Effect