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 经皮电神经刺激(TENS)在神经性眼痛(NOP)患者中的应用 未来使用的Active和Sham Ten协议的可行性和可接受性，随机- 对照试验：3)评估NOP患者长期使用TENS的止痛效果时程；4) 探讨NOP患者TENS治疗的可行性、安全性和止痛反应的受试者间差异。这 初步研究将招募50名患有慢性(&>6个月)NOP(无相关泪膜异常)的退伍军人 最低中等强度(0-10分疼痛评分≥4)。 将评估参与者的基线特征，包括人口统计、医疗和疼痛 眼痛的病史、特征和影响、眼科检查指标和诱发疼痛敏感性(访问1)。 然后，参与者将按2：1的比例随机分为主动或假TENS治疗组。最初的实验室内20分钟 将进行TENS会议，并以多次记录副作用和眼部疼痛缓解的报告 之后120分钟的时间点(访问2)。在指导学员如何安全地申请和开始之后 TENS设备，他们将带着活动或假设备离开实验室，以启动每周3次 治疗方案(每次20分钟)在家中进行，为期6个月。参赛者将接受评估 关于副作用的频率和严重程度，使用该设备的频率，以及通过双向评分进行的疼痛评级 每周与研究人员进行电话交流。治疗中点(3个月)和治疗结束(6个月)时间 积分，参与者将返回实验室进行疼痛特征评估、眼部检查和诱发 疼痛敏感性测量(访问3和4)。TENS设备记录的使用日志也将 当时已下载。将通过每月电话访谈进行额外的长期跟踪数据收集， 长达12个月，以捕捉任何挥之不去的副作用和眼痛评级的变化。 要使用的TENS设备是Cefaly Dual®(Cefaly Technology，比利时)，它提供双相 矩形脉冲(脉冲宽度250μS，频率60赫兹)，强度高达16 mA，通过单个 放置在额头眉毛正上方的电极。此前，该设备已被证明是 对减轻偏头痛有效。 初步分析将由描述性统计数据组成，以评估：1)招聘和保留的可行性 进入未来的疗效试验(目标是登记至少50%的符合条件的患者，并保留80% 登记)；2)设备的安全性(目标是不超过10%的参与者报告轻-中度 效果不会持续；0%报告与TENS治疗相关的严重副作用)；以及3) Sham TENS设备的可行性(目标是分配到Sham TENS的参与者中至少有50% 不确定他们被分配到哪个治疗臂)。此外，我们还将探索两者之间的关联 我们的结果(遵守方案、副作用报告和止痛效果)和个体的差异 特征(人口统计数据、眼部疼痛特征、眼科检查指标和对有害物质的敏感性 刺激/诱发疼痛)。