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）评估长期治疗的安全性和副作用 经皮神经电刺激（TENS）在神经性眼痛（NOP）患者中的应用； 2）评估 主动和假 TENS 协议在未来随机使用的可行性和可接受性 对照试验； 3）估计长期使用TENS治疗NOP的镇痛效果的时程；和 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 试点研究将招募 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 疼痛等级量表中≥ 4）。 将对参与者的基线特征进行评估，包括人口统计、医疗和疼痛 眼部疼痛的病史、特征和影响、眼科检查指标以及诱发疼痛的敏感性（访视 1）。 然后，参与者将以 2:1 的比例随机接受主动 TENS 治疗或假 TENS 治疗。初始实验室 20 分钟 将进行 TENS 会议，并在多个时间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）。在指导参与者如何安全申请和开始后 TENS 设备，他们将带着主动或假设备离开实验室以启动每周 3 次 在家治疗方案（每次 20 分钟），持续 6 个月。参与者将接受评估 关于副作用的频率和严重程度、设备的使用频率以及通过双- 每周与研究人员通电话。治疗中期（3 个月）和治疗结束（6 个月）时 点后，参与者将返回实验室评估疼痛特征、眼科检查指标和诱发因素 疼痛敏感性测量（访视 3 和 4）。 TENS 设备记录的使用日志也将被记录 当时下载的。额外的长期后续数据收集将通过每月电话访谈进行， 长达 12 个月，以捕捉任何挥之不去的副作用的存在以及眼痛评级的变化。 所使用的 TENS 设备是 Cefaly Dual ®（Cefaly Technology，比利时），可提供双相 通过单个矩形脉冲（脉冲宽度 250μS，频率 60Hz）强度高达 16mAmps 电极放置在眉毛上方的前额上。该设备之前已被证明是 有效减少偏头痛。 初步分析将包括描述性统计数据，以评估：1) 招聘和保留的可行性 进入未来的疗效试验（目标是招募至少 50% 的合格患者，并保留其中 80% 已注册）； 2）设备的安全性（目标是不超过10%的参与者报告有轻度至中度副作用 不持续的影响； 0% 报告出现与 TENS 治疗相关的严重副作用）； 3） Sham TENS 设备的可行性（目标是至少 50% 分配给 Sham TENS 的参与者 不确定他们被分配到哪个治疗组）。此外，我们将探索之间的关联 我们的结果（遵守方案、副作用报告和镇痛效果）和个人的差异 特征（人口统计、眼部疼痛特征、眼部检查指标以及对有害物质的敏感性） 刺激/诱发疼痛）。