Investigation of Non-Invasive Pulsed Electromagnetic Field (PEMF) Therapy for Female Patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

非侵入性脉冲电磁场​​ (PEMF) 治疗女性间质性膀胱炎/膀胱疼痛综合征 (IC/BPS) 患者的研究

• 批准号: 10593955
• 负责人: STEPHEN WALKER
• 金额: $ 31万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10593955
• 关键词: Adult; Analgesics; Anesthetics; Area; Bladder; Brief Pain Inventory; Characteristics; Clinic; Clinical Trials; Cognitive; Controlled Clinical Trials; Cystectomy; Data; Databases; Degenerative polyarthritis; Devices; Diagnosis; Disease; Double-Blind Method; Electrocoagulation; Electromagnetic Fields; Enrollment; Exclusion Criteria; Exhibits; Female; Fibromyalgia; Flare; Frequencies; Goals; Home; Inflammatory; Injections; Interstitial Cystitis; Intervention; Investigation; Lesion; Maintenance; Microcirculation; Mission; Multi-Institutional Clinical Trial; National Institute of Diabetes and Digestive and Kidney Diseases; Numeric Rating Scale; Opioid Analgesics; Outcome Measure; Pain; Pain management; Patient Recruitments; Patients; Pelvic Pain; Pelvis; Phenotype; Physiologic pulse; Placebo Control; Process; Publishing; Quality of life; Questionnaires; Randomized; Regenerative capacity; Regimen; Registries; Research Design; Rheumatoid Arthritis; Risk; Safety; Site; Symptoms; Syndrome; Testing; Therapeutic; Training; Treatment Protocols; Urologist; Work; antinociception; chronic painful condition; chronic pelvic pain; cohort; comparison group; diaries; experience; follow-up; pain perception; pain reduction; pain score; patient subsets; placebo controlled study; placebo group; primary outcome; recruit; regenerative tissue; response; safety testing; secondary outcome; treatment duration; treatment group

PROJECT SUMMARY The goal of this pilot and feasibility clinical trial is to acquire preliminary data regarding the safety and efficacy of the non-invasive pulsed electromagnetic field (PEMF) therapy for pain management in interstitial cystitis/bladder pain syndrome (IC/BPS) patients. We present preliminary data suggesting that IC/BPS comprises at least two distinct phenotypic subpopulations; one characterized as a bladder-centric disease process and the other characterized as a non-bladder-centric systemic pain syndrome. We propose to leverage our large patient database to recruit patients into this clinical trial wherein we will test the safety and efficacy of PEMF therapy. The trial will employ a single-site, randomized, double-blind, sham placebo-controlled study design. To accomplish the goals of this clinical trial, we propose the following three Specific Aims. Specific Aim 1: Determine the impact of PEMF therapy on pain reduction in IC/BPS patients. From our registry of 488 IC/BPS patients we will recruit 60 adult female patients who have met all inclusion/exclusion criteria, that includes: (1) 30 patients with an anesthetic BC≤400 anesthetic (i.e., bladder centric phenotype), and (2) 30 patients with an anesthetic BC>400 cc (i.e., those with a non-bladder centric (systemic) phenotype); all having a current numeric rating scale (NRS) pain score of ≥6. Patients within each of the two phenotypic groups will be randomly assigned (1:1 ratio) to either the PEMF treatment or sham group, trained in the clinic on the use of the PEMF device, and then undergo twice daily PEMF therapy (or sham) sessions at home for four weeks. The sham device is identical in every way to the treatment devices except it does not deliver a pulsed electromagnetic field. Patients will be assessed at enrollment, at follow-up after the 4-week treatment period, and then monthly for the next 3 months. The primary outcome measure will be a significant change in their pelvic pain score (i.e., a decrease ≥ 2). Secondary outcomes will be assessed by validated IC/BPS questionnaires (O’Leary-Sant), voiding characteristics (voiding diary), Brief Pain Inventory (BPI) Short Form, Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale, and Global Response Assessment (GRA). Specific Aim 2: Determine the duration of benefit from PEMF therapy with and without maintenance treatments. An additional cohort of 15 adult female patients with non-bladder centric IC/BPS will be recruited and undergo the standard 4-week regimen, followed by a one-week-per-month of twice daily PEMF therapy regimen for an additional 3 months. Primary and secondary outcomes will be assessed monthly, out to 4 months, as described in Aim 1. The results will be compared to the non-bladder centric patients treated for 4 weeks only in Aim 1. If results from Aim 1 show that there is no difference in the positive response between the two groups, or that PEMF therapy benefits bladder-centric patients more than non-bladder centric patients, then the patient make-up for Aim 2 will be adjusted accordingly (i.e., 8 patients from each group (N=16), or all 15 will be bladder- centric, respectively) and the comparator group(s) will be adjusted accordingly.

项目摘要 该试点和可行性临床试验的目的是获取有关安全性和效率的初步数据 用于间隙的疼痛管理的非侵入性脉冲电磁场​​（PEMF）治疗 膀胱炎/膀胱疼痛综合征（IC/BPS）患者。我们提出了提示IC/BPS的初步数据 包括至少两个不同的表型亚群；一种特征是以膀胱为中心的疾病 过程，另一个被认为是一种以非叶子为中心的全身性疼痛综合征。我们建议利用 我们的大型患者数据库将患者招募到该临床试验中，我们将测试 PEMF疗法。该试验将采用单点，随机，双盲，假安慰剂对照研究 设计。为了实现这项临床试验的目标，我们提出了以下三个特定目标。 具体目标1：确定PEMF疗法对IC/BPS患者疼痛减轻的影响。来自我们的 注册表为488名IC/BPS患者，我们将招募60名符合所有包容/排除的成年女性患者 标准，其中包括：（1）30例麻醉BC≤400麻醉的患者（即以膀胱为中心表型）和 （2）30例麻醉BC> 400 cc的患者（即具有以非叶片为中心的（全身）表型的患者；全部 当前的数字评分量表（NRS）疼痛评分为≥6。两个表型组中的每个患者 将随机分配（1：1比率）与PEMF治疗或假手术组，在诊所接受培训 PEMF设备，然后在家中每天进行两次PEMF治疗（或假）课程四个星期。 假设备在各种方面都与治疗设备相同，除了未提供脉冲 电磁场。在入学期间，在4周治疗期后随访时将对患者进行评估， 然后每月在接下来的3个月中。主要结局指标将是其骨盆的重大变化 疼痛评分（即减少≥2）。次要结果将通过经过验证的IC/BPS问卷进行评估 （O'Leary-Sant），空隙特征（空隙日记），短暂疼痛清单（BPI）短形式，骨盆疼痛和 紧迫性/频率（PUF）患者症状量表和全球反应评估（GRA）。 特定目的2：确定PEMF治疗的福利持续时间，并没有维护 治疗。还将招募另外15名具有以非叶片为中心的IC/BP的成年女性患者组成的队列 并接受标准的4周治疗方案，其次是每天两次PEMF疗法 方案又有3个月。初级和次要结果将每月评估，到4个月， 如AIM 1所述。结果将与仅治疗4周的非叶片中心患者进行比较 在AIM 1中。如果AIM 1的结果表明两组之间的正反应没有差异， 或PEMF疗法比以非叶片为中心的患者对以膀胱为中心的患者有益于患者，然后患者 AIM 2的化妆将进行相应调整（即每组的8例患者（n = 16），或所有15例均为Bladeder- 分别以中心为中心）和比较组将进行相应调整。