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.

抽象的 间质性膀胱炎/膀胱疼痛综合征（IC/ BPS）是最令人衰弱的慢性骨盆疼痛之一（CPP） 在美国2.7％至6.5％的妇女中对生活质量和性活动产生负面影响的条件。 CPP患者中普遍存在骨盆底高渗（PFH），最多有85％的女性 与IC/BPS。 PFH是一个多因素问题，涉及骨盆肌肉放松受损 激活伤害感受器和炎症化学物质的释放。当前采用的临床策略 物理治疗干预措施以放松肌肉以改善肌肉协调。替代疗法 当保守方法失败时，可能会建议使用口服或阴道内肌肉松弛剂。具体来说， 肉毒杆菌神经毒素（BONT）对管理继发于PFH的骨盆疼痛的兴趣越来越大。 Bont 抑制神经肌肉连接处的神经肌肉传播，由神经肌肉（IZS），通过 阻止乙酰胆碱释放，导致短暂的肌肉松弛和缓解疼痛症状。 尽管具有效力和安全性，但BONT仍会引起剂量依赖性的不良反应，并且很昂贵。研究 已经证明，将注入距离增加与IZS的1厘米降低了BONT的影响 46％。在体内定位IZ分布在骨盆底肌肉中以指导精度很重要 注射BONT，以降低治疗成本，以进行最佳治疗功效。 我们的团队已成功开发了一种新型的高密度表面肌电图（HD-SEMG）技术 到1）可靠，定量评估PFH，2）准确地对高渗PFM的IZ分布进行成像， 3）成功证明了BONT注射的治疗结果的显着改善 在管理肌肉痉挛方面，使用HD-SEMG与没有HD-SEMG指导的无指导。该提议的目的是 开发一种个性化的，精确的BONT注入方法，由阴道内HD-SEMG进行优化 IC/BPS管理中的治疗结果。这项研究代表了定量和 客观地研究使用体内hd-semg进行个性化的，精确的指导性Bont的可行性 注射以优化IC/BP的诊断和治疗。提出的技术将作为体内 骨盆底表型工具，可用于向个性化的个性化注入BONT 具有个性化剂量的注射部位，这将导致更有效的BONT治疗 治疗成本（通过减少注射剂量）。这项研究还将提高我们对 PFH的病理生理学和BONT管理机制，并帮助建立高级标准 PFH和BONT注射的客观评估。