A pilot study of the safety and feasibility of transcutaneous electrical nerve stimulation (TENS) for chronic ocular pain

经皮神经电刺激 (TENS) 治疗慢性眼痛的安全性和可行性初步研究

• 批准号: 10656409
• 负责人: Elizabeth Roy Felix
• 金额: --
• 依托单位: MIAMI VA HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10656409
• 关键词: Activities of Daily Living; Acute; Address; Adherence; Adjuvant Therapy; Analgesics; Award; Belgium; Benchmarking; Characteristics; Chronic; Clinical; Data; Data Collection; Devices; Diagnosis; Dry Eye Syndromes; Dryness; Effectiveness; Electrodes; Eligibility Determination; Enrollment; Ensure; Environmental Wind; Esthesia; Eyebrow structure; Feasibility Studies; Film; Forehead; Frequencies; Functional disorder; Future; Goals; Health; Home; Hypersensitivity; Individual; Intervention; Interview; Laboratories; Light; Long-Term Effects; Longterm Follow-up; Measures; Medical; Methodology; Metric System; Migraine; Nervous System; Neuropathy; Outcome; Pain; Pain Measurement; Participant; Patients; Peripheral; Persons; Phase; Phenotype; Pilot Projects; Protocols documentation; Qualifying; Quality of life; Randomized; Randomized, Controlled Trials; Recording of previous events; Reporting; Research; Research Design; Resources; Risk; Safety; Serious Adverse Event; Severities; System; Technology; Telephone; Testing; Time; Transcutaneous Electric Nerve Stimulation; Translating; Treatment Protocols; Variant; Veterans; Visit; Width; Work; acceptability and feasibility; chronic pain; chronic painful condition; clinical diagnosis; clinically relevant; clinically significant; demographics; design; effective therapy; effectiveness evaluation; efficacy trial; eligible participant; experience; eye dryness; improved; interest; longitudinal analysis; multidisciplinary; ocular pain; ophthalmic examination; overtreatment; pain patient; pain relief; pain sensation; pain sensitivity; pain symptom; participant enrollment; pilot trial; prevent; programs; randomized placebo controlled study; recruit; reduce symptoms; response; safety and feasibility; safety study; screening; side effect; somatosensory; sound; statistics; treatment arm; treatment duration; treatment effect

The aims of the proposed work are to: 1) evaluate the safety and side-effect profile of long-term Transcutaneous Electrical Nerve Stimulation (TENS) use in neuropathic ocular pain (NOP) patients; 2) assess the feasibility and acceptability of the Active and Sham TENS protocols for use in a future, randomized- controlled trial; 3) estimate the time-course of analgesic effect of long-term use of TENS for NOP; and 4) explore between-subject variability in feasibility, safety, and analgesic responsiveness to TENS for NOP. This pilot study will enroll 50 Veterans with chronic (>6 mo) NOP (without associated tear film abnormalities) of at least moderate intensity (≥ 4 on a 0 – 10 pain rating scale). Participants will be assessed with regard to baseline characteristics, including demographics, medical and pain history, characteristics and impact of ocular pain, eye exam metrics, and evoked pain sensitivity (Visit 1). Participants will then be randomized, in a 2:1 ratio, to Active or Sham TENS therapy. An initial in-lab 20-minute session of TENS will be performed and reports of side effects and ocular pain relief will be recorded at multiple time points for 120 minutes afterward (Visit 2). After participants are instructed on how to safely apply and start the TENS device, they will leave the laboratory with the Active or Sham device to initiate the 3-times-per-week treatment protocol (20 mins per session) at home, for a duration of 6 months. Participants will be assessed with regard to the frequency and severity of side-effects, frequency of use of the device, and pain ratings via bi- weekly phone calls with the study staff. At the mid-point (3 months) and end-of-treatment (6 months) time points, participants will return to the lab for assessments of pain characteristics, eye exam metrics, and evoked pain sensitivity measures (Visits 3 and 4). The utilization log recorded by the TENS device will also be downloaded at that time. Additional long-term follow-up data collection will occur via monthly phone interviews, up to 12 months, to capture the presence of any lingering side-effects and change in ocular pain ratings. The TENS device to be used is the Cefaly Dual ® (Cefaly Technology, Belgium), which delivers biphasic rectangular impulses (impulse width 250μS, frequency 60Hz) of up to 16mAmps in intensity via a single electrode that is placed on the forehead just above the eyebrows. The device has previously been shown to be effective for the reduction of migraine. Primary analyses will consist of descriptive statistics to assess: 1) the feasibility for recruitment and retention into a future efficacy trial (goal is enrollment of at least 50% of eligible patients, and retention of 80% of those enrolled); 2) the safety of the device (goal is that no more than 10% of participants report mild-moderate side effects that do not persist; and 0% report a severe side-effect related to the TENS treatment); and 3) the feasibility of the Sham TENS device (goal is that at least 50% of participants allocated to Sham TENS are unsure of which treatment arm they were assigned to). In addition, we will explore associations between variation in our outcomes (adherence to protocol, side-effect report, and analgesic effectiveness) and individual characteristics (demographics, ocular pain characteristics, ocular exam metrics, and sensitivity to noxious stimulation/evoked pain).

拟议工作的目的是：1）评估长期的安全性和副作用概况 神经性眼疼痛（NOP）患者的经牙性电神经刺激（TENS）使用； 2）评估 活动和假手术的可行性和可接受性，用于将来的随机 - 随机使用 对照试验； 3）估计长期使用TEN的镇痛作用的时间顺序；和4） 探索对NOP的可行性，安全性和镇痛反应性的受试者间变异性。这 试点研究将招募50名退伍军人，以慢性（> 6 mo）NOP（没有相关泪液异常）的AT招募 最低强度（在0 - 10疼痛评级量表上≥4）。 将对参与者的基线特征进行评估，包括人口统计学，医学和疼痛 眼部疼痛，眼科检查指标和诱发疼痛敏感性的病史，特征和影响（访问1）。 然后，参与者将以2：1的比例随机分配与主动或假疗法的比例。最初的外部时间20分钟 将进行数十个会议，并记录多个副作用和副作用的报告 时间点持续120分钟（访问2）。在指示参与者有关如何安全申请和开始之后 他们将使用活跃或假装置离开实验室，每周启动3倍的设备 在家中的治疗方案（每次疗程20分钟），持续6个月。参与者将被评估 关于副作用的频率和严重程度，设备的使用频率以及通过bi-的疼痛等级 每周与学习人员打来电话。在中点（3个月）和治疗终点（6个月）时间 要点，参与者将返回实验室以评估疼痛特征，眼科检查指标，并引起了人们的注意 疼痛敏感性措施（访问3和4）。 TENS设备记录的利用日志也将是 当时下载。额外的长期随访数据收集将通过每月电话采访， 长达12个月，以捕获任何挥之不去的副作用和眼部疼痛等级的变化。 要使用的TENS设备是CefalyDual®（Cefaly Technology，Belgium），可提供双相 矩形脉冲（冲动宽度250μs，频率60Hz）的强度高达16MAMPS 放在眉毛上方的额头上的电极。该设备以前已显示为 有效减少偏头痛。 主要分析将包括描述性统计数据：1）招聘和保留的可行性 进入未来的效率试验（目标是至少有50％的合格患者入学，保留80％ 注册）； 2）设备的安全性（目标是不超过10％的参与者报告温和中度的一侧 不持续存在的效果； 0％报告与TENS治疗相关的严重副作用）； 3） 假手机设备的可行性（目标是至少有50％分配给假的参与者 不确定他们被分配到哪个治疗臂）。此外，我们将探讨 我们的结果（遵守协议，副作用报告和镇痛有效性）和个人的变化 特征（人口统计学，眼部疼痛特征，眼考试指标和对有害的敏感性 刺激/诱发疼痛）。