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临床试验/NCT06649604
NCT06649604尚未招募不适用

Alleviating Panretinal Photocoagulation Associated Ocular Pain With Vibratory Stimulation

University of Alberta2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
2
主要终点
Pain Rating Scale

研究概览

简要总结

The goal of this clinical trial is to learn if Vibration Anesthesia Device works to reduce pain during retinal laser for diabetic retinopathy. The main question it aims to answer is:

Does the Vibration Anesthesia Device reduces the pain felt by patients during the laser treatment? Researchers will compare the standard method (no vibration device) to the standard method with the Vibration Anesthesia Device to see if the device works to reduce discomfort during treatment.

Eligible participants will have both eyes treated as required, one eye with the device and the other one without. Both the side that will be treated with the device in place and the first side to be treated will be decided by random sequence.

详细描述

Background:

Panretinal photocoagulation (PRP) is a widely used laser treatment for proliferative diabetic retinopathy (PDR). However, the associated ocular pain can make the procedure uncomfortable, leading to increased treatment visits or missed appointments. This pain is multifactorial and can be exacerbated by factors such as anxiety and hypervigilance. Traditional pain management techniques, such as regional anesthesia, are effective but invasive and carry potential complications. Oral medications have largely proven ineffective in alleviating PRP-related pain.

The Gate-Control Theory of pain posits that non-noxious stimuli can inhibit pain signals by activating A-β fibers, effectively "closing the gate" to pain transmission through A-δ and C fibers. The most relatable example is the mother rubbing a child's knee after an impact injury in the affected region. Transcutaneous electrical nerve stimulation (TENS) which utilizes the Gate-Control Theory of pain, has been shown to reduce ocular pain during PRP. However, its use raises practical concerns, including the need to carefully adjust pulse width, intensity, and frequency for effective pain relief. Additionally, some patients may find the muscular contractions or paresthesia uncomfortable. TENS is also contraindicated in individuals who are pregnant, have epilepsy, or have pacemakers. Vibratory stimulation activates cutaneous mechanoreceptors to reduce pain during intramuscular and subcutaneous injections. This technique is safer and less invasive than TENS and is therefore an ideal candidate for evaluating its effect in pain reduction during PRP. This study has the potential for an innovative concept by utilizing a vibratory device integrated within the PRP machine headrest.

Hypothesis:

Vibratory stimulation is expected to reduce ocular pain during PRP by activating cutaneous mechanoreceptors and inhibiting pain transmission, as suggested by the Gate-Control Theory. Its non-invasive nature makes it a practical alternative to traditional pain management methods, potentially enhancing patient comfort during the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Only the collaborator who will analyse the data will be masked, due to the manifest presence or absence of the vibratory device for both the clinician and the patient.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Treatment naïve patients
  • Bilateral PRP for proliferative diabetic retinopathy required
  • >500 applications to each eye
  • < 51 applications difference between each eye, in the superior or inferior hemisphere.

排除标准

  • Poor pupil dilation < 5mm
  • Media opacity preventing laser

结局指标

主要结局

Pain Rating Scale

时间窗: At time of enrolment

Patient are enrolled on the same day as the study treatment. Patients will rate their pain sensation. They will have their first eye (left or right and with or without the Anesthesia Vibration Device based on randomization) treated, then they will assess their pain sensation. After this assessment, during the same session, their second eye will be treated and they will be asked to complete the same assessment for this second eye. The provided form to assess this outcome is a numeric scale from 0 (no pain) to 10 (worst possible pain) using the Wong-Baker Faces scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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