High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain

高密度表面肌电图引导精准肉毒杆菌神经毒素注射治疗慢性盆底疼痛

• 批准号: 10681340
• 负责人: Yingchun Zhang
• 金额: $ 30.38万
• 依托单位: UNIVERSITY OF HOUSTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-15 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10681340
• 关键词: Acetylcholine; Adverse effects; Alternative Therapies; Botulinum Toxins; Chemicals; Chronic; Clinical; Clinical Trials; Crossover Design; Data; Diagnosis; Disease; Dose; Electromyography; Ensure; Etiology; Feasibility Studies; Foundations; Functional disorder; Future; Goals; Hyperalgesia; Image; Impairment; Individual; Inflammatory; Injections; Interstitial Cystitis; Maps; Methods; Mission; Muscle; Muscle Spasticity; Muscle relaxants; Muscle relaxation phase; National Institute of Diabetes and Digestive and Kidney Diseases; Neuromuscular Junction; Nociceptors; Oral; Pain; Patients; Pattern; Pelvic Floor Muscle; Pelvic Pain; Pelvic floor structure; Pelvis; Phenotype; Physical therapy; Protocols documentation; Quality of life; Randomized; Randomized Controlled Clinical Trials; Relaxation; Research; Safety; Secondary to; Severities; Sex Behavior; Site; Skeletal Muscle; Surface; Techniques; Therapeutic Intervention; Training; Treatment Cost; Treatment Efficacy; Treatment outcome; Woman; botulinum neurotoxin injection; botulinum toxin treatment; chronic pelvic pain; density; dosage; efficacy testing; improved; in vivo; interest; nerve supply; neuromuscular transmission; novel; optimal treatments; pain relief; pain symptom; personalized approach; recruit; research clinical testing; response; success; tool; treatment optimization; treatment strategy

Abstract Interstitial cystitis/ bladder pain syndrome (IC/BPS) is one of the most debilitating chronic pelvic pain (CPP) conditions that negatively impacts the quality of life and sexual activities in 2.7% to 6.5% of women in the US. Pelvic floor hypertonicity (PFH) is prevalent among patients with CPP, and is present in up to 85% of women with IC/BPS. PFH is a multifactorial problem that involves impaired relaxation of the pelvic musculature due to the activation of nociceptors and release of inflammatory chemicals. Current clinical strategies employ physical therapy interventions to relax the muscle to improve muscle coordination. Alternative therapies that use oral or intra-vaginal muscle relaxants may be suggested when conservative methods fail. Specifically, botulinum neurotoxin (BoNT), has received growing interest in managing pelvic pain secondary to PFH. BoNT inhibits the neuromuscular transmission at neuromuscular junctions, indicated by innervation zones (IZs), by blocking the acetylcholine release, leading to transient muscle relaxation, and the relief of pain symptoms. Despite its potency and safety, BoNT can cause dose-dependent adverse effects and is expensive. Studies have demonstrated that increasing the injection distance by 1 cm from the IZs reduced the effect of BoNT by 46%. It is clinically important to localize in vivo the IZ distributions in the pelvic floor muscles to guide precision BoNT injections for optimal treatment efficacy with reduced treatment cost. Our team has successfully developed a novel high-density surface electromyography (HD-sEMG) technique to 1) reliably and quantitatively assess PFH and 2) accurately image the IZ distributions of hypertonic PFMs, and has 3) successfully demonstrated the significant improvement in treatment outcome of BoNT injection with HD-sEMG vs. without HD-sEMG guidance, in managing muscle spasticity. The goal of this proposal is to develop a personalized, precision BoNT injection approach guided by intra-vaginal HD-sEMG to optimize the treatment outcome in IC/BPS management. This research represents the first effort to quantitatively and objectively study the feasibility of using intra-vaginal HD-sEMG for personalized, precision guided BoNT injections to optimize the diagnosis and treatment of IC/BPS. The proposed technique will serve as an in vivo pelvic floor phenotyping tool that can be used to deliver personalized injection of BoNT to personalized injection sites with personalized doses, which will lead to more effective BoNT treatment with reduced treatment cost (by reducing injection dose). The study will also advance our understanding of the pathophysiology of PFH, and mechanism of BoNT management, and help establishing an advanced standard of objective assessment of PFH and BoNT injections.

摘要 间质性膀胱炎/膀胱痛综合征(IC/BPS)是慢性盆腔疼痛(CPP)中最具破坏性的疾病之一。 在美国，2.7%至6.5%的女性患有对生活质量和性行为产生负面影响的疾病。 盆底高张症(PFH)在慢性盆底炎患者中很普遍，在85%的女性中存在。 带IC/BPS。PFH是一个多因素的问题，涉及骨盆肌肉松弛受损，由于 伤害性感受器的激活和炎性化学物质的释放。当前的临床策略使用 物理疗法干预放松肌肉，提高肌肉协调性。另类疗法， 当保守方法无效时，可建议使用口服或阴道内肌松药。具体来说， 肉毒杆菌神经毒素(BONT)在治疗继发于PFH的盆腔疼痛方面受到越来越多的关注。邦特 抑制神经肌肉交界处的神经肌肉传递，由神经支配区域(IZS)指示，通过 阻断乙酰胆碱释放，导致一过性肌肉松弛，缓解疼痛症状。 尽管BONT的效力和安全性很高，但它会引起剂量依赖性的不良反应，而且价格昂贵。研究 已经证明，将注入距离增加1厘米可降低BONT的效果 46%。在活体内定位盆底肌肉中的IZ分布以指导精确度具有重要的临床意义。 BONT注射可在降低治疗成本的情况下实现最佳治疗效果。 我们的团队成功开发了一种新的高密度表面肌电(HD-sEMG)技术 为了1)可靠地和定量地评估PFH和2)准确地成像高渗PFM的IZ分布， 3)成功地证实了骨钙素注射治疗效果的显著改善。 在治疗肌肉痉挛方面，使用HD-sEMG与不使用HD-sEMG指导的比较。这项提议的目标是 开发一种在阴道内HD-sEMG引导下的个性化、精确的BONT注射方法，以优化 IC/BPS治疗的治疗结果。这项研究代表了第一次从数量上和 客观研究阴道内HD-sEMG用于个性化、精确引导骨盆的可行性 注射治疗以优化IC/BPS的诊断和治疗。这项拟议的技术将作为体内的 盆底表型工具，可用于向个性化提供个性化的BONT注射 注射部位有个性化的剂量，这将导致更有效的BONT治疗，减少 治疗成本(通过减少注射剂量)。这项研究也将增进我们对 PFH的病理生理学，以及BOT的管理机制，并有助于建立先进的标准 对PFH和BONT注射的客观评估。