A Pilot Study of the Safety and Feasibility of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Ocular Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Reported Device-related Side-effects
研究概览
简要总结
Approximately 20% of Veterans have a diagnosis of dry eye (DE) syndrome which is often accompanied by ocular pain that significantly impacts activities of daily living. Currently very few treatments are available for chronic ocular pain, likely because the mechanisms underlying this type of pain have only recently begun to be studied. New treatments that target the neuropathic mechanisms contributing to this type of pain are needed. The proposed research provides a crucial step in addressing the lack of treatments for neuropathic ocular pain by validating the methodology needed to support a randomized controlled trial of transcutaneous electrical nerve stimulation (TENS). TENS is a non-pharmacologic, non-addictive, non-invasive treatment that has been shown to be effective in other chronic pain conditions. The present pilot study aims to address the need for preliminary support of safety and efficacy of TENS for ocular pain, t to advance the study of new treatments for the long-term relief of chronic ocular pain and its impact on health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants and all study staff involved in participant evaluations will be blinded to treatment allocation. Each device will have the stimulation program pre-set according to the randomization assignment and be numbered. The randomization assignment will be held by the study statistician to match the device number to the intervention assignment. Devices will be distributed in numeric order according to the participant's chronologic order of enrollment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female
- •all races and ethnicities
- •at least 18 years of age
- •persistent eye pain for at least 6 months
- •average eye pain intensity of 4 or more on a 0-10 numerical rating scale
- •on a stable medication regimen for at least the past 3 months
- •naïve to TENS use for orofacial conditions
- •eye pain having neuropathic-like characteristics
排除标准
- •presence of ocular diseases that are the likely cause of pain (i.e., corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, etc.)
- •contraindication to TENS (i.e., pacemaker, cardioverter defibrillator, neuro-stimulation (brain or spinal cord), bone growth stimulations, indwelling blood pressure monitors, epilepsy, pregnancy)
- •patients with confirmed signs of tear dysfunction
- •current participation in another study with an investigational drug or device within one month prior to screening
研究组 & 干预措施
high frequency TENS
high frequency (60Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
干预措施: High frequency forehead TENS (Device)
low frequency TENS
low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
干预措施: Low frequency forehead TENS (Device)
结局指标
主要结局
Reported Device-related Side-effects
时间窗: 6 months
An open-ended question of side-effects will be used to assess any bothersome changes in physical or mental health symptoms every 2 weeks during the 6-month at-home course of treatment. Presence, description of symptom, severity of symptoms, participant assessment of device/treatment-relatedness of symptoms, and desire or actual discontinuation of device use will be recorded.
Time to Peak Change in Numerical Rating Scale (NRS, 0-10)
时间窗: 6 months
Calculation of time (weeks) to peak reduction in eye pain will be made based on NRS scores obtained every two weeks after initiation of intervention protocol.
Number of Screen Failures
时间窗: 6 months
The number of individuals who meet pre-screening requirements, consent to study procedures, but who do not meet full criteria after screening visit is conducted
Treatment Compliance Rate
时间窗: 6 months
Count of the number (and calculated percentage) of individuals who reported completing at least 75% of treatment sessions.
次要结局
- Rate of Uncertainty in Participant Treatment Allocation Guess(6 months)
- Percentage of Individuals Who Score 100% on Checklist for Proper Use of TENS Device(baseline)