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).

拟开展的工作的目的是：1）评价长期使用的安全性和副作用。 经皮神经电刺激（TENS）用于神经性眼痛（NOP）患者; 2）评估 主动和假TENS方案用于未来随机化的可行性和可接受性- 对照试验; 3）估计长期使用TENS治疗NOP的镇痛效果的时间过程;以及4） 探索TENS治疗NOP的可行性、安全性和镇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， 最小中度强度（0 - 10疼痛评定量表≥ 4）。 将对参与者的基线特征进行评估，包括人口统计学、医疗和疼痛 眼部疼痛的病史、特征和影响、眼部检查指标和诱发的疼痛敏感性（访视1）。 然后，受试者将以2：1的比例随机分配至主动或假TENS治疗组。最初的20分钟实验室内 将进行TENS治疗，并记录多个时间点的副作用和眼部疼痛缓解报告。 120分钟后（访视2）。在指导参与者如何安全地申请和开始 TENS设备，他们将与Active或Sham设备一起离开实验室，以启动每周3次 治疗方案（每次20分钟）在家里，持续6个月。将对参与者进行评估 关于副作用的频率和严重程度、器械的使用频率以及通过双 每周与研究工作人员进行电话联系。治疗中期（3个月）和治疗结束（6个月）时 点，参与者将返回实验室进行疼痛特征评估，眼科检查指标， 疼痛敏感性测量（访视3和4）。TENS设备记录的使用日志也将 当时下载的。额外的长期随访数据收集将通过每月电话访谈进行， 长达12个月，以捕捉任何残留副作用的存在和眼部疼痛评级的变化。 待使用的TENS装置是Cefaly Dual ®（Cefaly Technology，比利时），其递送双相的 矩形脉冲（脉冲宽度250μS，频率60 Hz），通过单个 一个放置在前额眉毛上方的电极。该设备以前曾被证明是 对减轻偏头痛有效。 主要分析将包括描述性统计，以评估：1）招募和保留的可行性 进入未来的疗效试验（目标是招募至少50%的合格患者，并保留80%的患者） 入组）; 2）器械的安全性（目标是不超过10%的参与者报告轻度-中度侧 不持续的影响;和0%报告与TENS治疗相关的严重副作用）;和3） 假TENS设备的可行性（目标是至少50%的分配到假TENS的参与者是 不确定他们被分配到哪个治疗组）。此外，我们还将探讨 我们的结局（方案依从性、副作用报告和镇痛有效性）和个体差异 特征（人口统计学、眼痛特征、眼部检查指标和对有害物质的敏感性） 刺激/诱发疼痛）。