Development Of An Acupuncture/Microdialysis Needle For P

针灸/微透析针的研制

• 批准号: 7319081
• 负责人: Terry M. Phillips
• 金额: --
• 依托单位: OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7319081
• 关键词: Development; Acupuncture; Microdialysis; Needle

Myofascial pain is associated with the formation of pain "trigger" points or defined areas within a muscle block that exhibit tenderness and abnormal tightness. Acupuncture is an alternative approach to releasing trigger points, thus relieving pain and the associated muscle tension in many cases. Although this therapeutic approach is efficacious there is little scientific evidence to support the clinical relief shown following treatment. DBEPS designed and developed an acupuncture needle with a hollow stem through which a twin tube microdialyzer could be inserted. The exterior bore of the needle was 28 - 30 gauge stainless surgical steel, with one end beveled into a blunt, non-cutting tip by micro-polishing. A 100,000 m.w. cutoff dialyzer membrane was attached to a 30-gauge poly-ether-ether-ketone (PEEK) biocompatible tubing and a 33-gauge PEEK tubing inserted into the first tube, thus forming a inlet and return flow-path terminating in the dialyzer membrane. This apparatus was fixed inside the stainless steel tubing so that the dialyzer surface was flush with the hole in the needle tip. A handle was fixed to the other end of the needle allowing the operator to manipulate the needle in a similar manner to a solid acupuncture needle. Three groups of patients, two with various degrees of muscle pain and tension plus controls, were recruited to the study. The acupuncture needle was inserted in the shoulder muscle by a skilled acupuncture specialist and samples taken, via microdialysis, from the needle tip. The samples were collected and analyzed for a variety of analytes such as blood gases, cytokines, hormones, neuropeptides, and electrolytes by the DBEPS Ultramicro Analytical Immunochemistry Resource, using established techniques (capillary electrophoresis, capillary electrochromatography, micro-ion selective electrochemistry and micro gas sensors). This project is recruiting subjects under an IRB-approved protocol and has completed the first phase of the protocol. There were clear differences between the three test groups, the normal group demonstrating little to no variation over the entire treatment time. The latent group demonstrated moderate concentrations of pain-associated neuropeptides as well as inflammatory cytokines. These concentrations returned to normal during the elicitation of a "twitch" reaction or firing of the trigger point. Additionally, the subjects unanimously stated that they felt pain relief and loss of muscle discomfort following treatment. The severe group demonstrated relatively high, localized concentrations of pain-associated neuropeptides and inflammatory cytokines, which became reduced but not completely removed during the treatment. Although some pain relief was noted, the majority of the subjects continued to feel some degree of muscle tension and light pain. Further studies are in progress to examine the effects of repeat treatments and chemical changes in these subjects as compared to normals. Studies are ongoing to determine if the biochemical and immunological changes seen during "dry-needling" of active trigger points is unique for the trigger point itself. A series of subjects were tested in which the needle was inserted not only into the actual trigger point itself but also into an unrelated muscle, i.e. the calf muscle. These studies are still underway but early analysis suggests that patients with active trigger points have a generally higher level of inflammatory biomarkers independent of the muscle sampled. Additionally, plans are underway to investigate the potential of the needle to deliver medications via the microdialysis tip to defined anatomical areas, especially muscle trigger points.

肌筋膜痛与肌肉块内疼痛“触发点”或特定区域的形成有关，这些区域表现出压痛和异常紧张。针灸是另一种释放触发点的方法，从而在许多情况下缓解疼痛和相关的肌肉紧张。虽然这种治疗方法是有效的，但几乎没有科学证据支持治疗后的临床缓解。DBEPS设计和开发了一种带有中空针杆的针灸针灸，可以通过它插入双管微透析器。针的外孔是28-30号不锈钢，通过微抛光将一端倒角成钝的、非切割的尖端。一辆10万辆的大众汽车将截止式透析膜附着在一根30口径的聚醚醚酮(PEEK)生物相容管上，并将一根33口径的PEEK管插入第一根PEEK管上，从而形成一条入口和回流通道，终止于透析器膜。该装置固定在不锈钢管内，使透析器表面与针尖上的孔齐平。手柄固定在针的另一端，允许操作员以类似于实心针灸针的方式操纵针。三组患者，两名有不同程度的肌肉疼痛和紧张加上对照组，被招募到这项研究中。针刺针由熟练的针灸专家插入肩部肌肉，并通过微透析从针尖采集样本。DBEPS超微分析免疫化学资源使用成熟的技术(毛细管电泳法、毛细管电泳法、微离子选择性电化学法和微型气体传感器)收集样本并分析各种分析物，如血气、细胞因子、激素、神经肽和电解质。该项目正在根据IRB批准的方案招募受试者，并已完成方案的第一阶段。三个试验组之间有明显的差异，正常组在整个治疗时间内表现出很小的变化或没有变化。潜伏组表现出中等浓度的疼痛相关神经肽以及炎性细胞因子。在触发“抽动”反应或触发触发点期间，这些浓度恢复到正常水平。此外，受试者一致表示，他们在治疗后感到疼痛减轻，肌肉不适消失。重度组疼痛相关神经肽和炎性细胞因子的局部浓度相对较高，在治疗过程中有所减少，但并未完全消除。虽然疼痛有所缓解，但大多数受试者仍感觉到一定程度的肌肉紧张和轻微疼痛。进一步的研究正在进行中，以检验重复治疗和化学变化对这些受试者与正常受试者的影响。 研究正在进行中，以确定在“干针”活性触发点期间看到的生化和免疫学变化是否对触发点本身是独一无二的。研究人员对一系列受试者进行了测试，其中不仅将针插入实际的触发点本身，还将针插入无关的肌肉，即小腿肌肉。这些研究仍在进行中，但早期分析表明，具有活跃触发点的患者通常具有较高水平的炎症生物标记物，独立于所采样的肌肉。此外，正在计划研究通过微透析尖端将药物输送到确定的解剖区域，特别是肌肉触发点的针的潜力。