Closing the Gate: Investigating a No-Cost, Noninvasive, Patient-Driven Approach to Pain Reduction for Trigger Finger Injections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS) Score
研究概览
简要总结
The goal of this clinical trial is to investigate a new noninvasive technique that patients may use to help reduce the pain that they experience during cortisone injections for trigger fingers. It will also help provide information that may help support the gate control theory of pain as a framework for understanding and managing acute pain.The main questions it aims to answer are:
Can a physical stimulus near the site of cortisone injection reduce the pain experienced by the patient during the injection? Does the physical stimulation or the cognitive distraction contribute more to pain relief?
Researchers will compare a physical stimulus near the injection site to a placebo (a similar task that theoretically should not reduce the experience of pain) to see if physical stimuli work to improve pain during injections.
Participants will:
Estimate how much pain they expect to experience during a cortisone injection Receive a cortisone injection for a trigger finger while performing one of three possible actions (control, placebo task, or the investigated physical stimulus near the injection site) Express how much pain they actually experienced during the injection
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
- Single (Participant)
盲法说明
Patients remained blinded to their assigned intervention until after all study procedures were complete.
Injecting provider was technically blinded but was functionally unblinded at the time of the injection itself due to the visible and audible differences between each group throughout the course of the injection.
Outcome assessor was blinded while instructing patients how to denote their pain level after the procedure, but was unblinded at the time of the injection. No input was given by the outcome assessor after they were unblinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are at least 18 years of age.
- •Have been diagnosed with one or more "trigger fingers" of the index, middle, ring, or small fingers.
- •Have decided to try a cortisone injection for one or more trigger fingers today as advised by your physician.
- •Are able to read and understand these study procedures.
排除标准
- •Are severely visually impaired.
- •Have a history of spinal cord injury.
- •Have taken opioid pain medications in the last 28 days.
- •Are currently pregnant.
结局指标
主要结局
Visual Analog Scale (VAS) Score
时间窗: Immediately after injection (within 10 seconds)
Patients denote the pain they experienced during the injection based on a standard 100-mm Visual Analog Scale. Scores range from 0-100, with lower scores indicating less pain. A score of 0 indicates no pain at all, while a score of 100 indicates the worst pain possible.
次要结局
未报告次要终点
研究者
Aidan Crislip
Principal Investigator
Grand Canyon University