The Effect of Vibratory Anesthesia on Patient Pain Perception in Corticosteroid Injections of the Upper Extremity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Hand
研究概览
简要总结
This research study aims to evaluate injectional pain at the site of needle insertion for corticosteroid injections (CSI) of the upper extremity depending on different modes of anesthetics. Each individual's perception of pain upon receiving a CSI with two out of three modes of anesthesia (control/no anesthesia, vibrational anesthesia, vapo-coolant anesthesia) will be utilized to compare these variables and determine the method that is associated with the least pain.
详细描述
As part of standard medical care, participants receive corticosteroid injections to the bilateral upper extremities. Following written informed consent, participants undergo the study procedures described below. Each participant receives a total of two injections, with one injection administered in each arm during a single study visit.
The type of anesthesia used for each injection is determined by random assignment using a computer-generated randomization sequence within the REDCap system. Participants are assigned to one of the following anesthesia combinations:
No anesthesia and vapocoolant spray topical anesthetic applied prior to injection No anesthesia and vibration anesthesia using the DigiVibe device throughout the duration of the injection Vapocoolant spray topical anesthetic applied prior to injection combined with vibration anesthesia using the DigiVibe device throughout the duration of the injection
For participants assigned to a DigiVibe group, the device is applied directly to the skin. The device contains a circular component that contacts the skin surface and provides vibratory stimulation. The injection is administered within the circular area while vibration is applied.
Upon completion of each injection, participants complete a numeric pain rating scale to assess perceived pain and comfort associated with the anesthesia method used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Any patient of the Principal Investigator who has clinically diagnosed bilateral arthritis, tendinopathy, arthropathy, or compression neuropathy of the hand, wrist, or elbow where treatment with corticosteroid injection is indicated.
- •Participants who voluntarily consent to participate in the study and sign consent forms.
- •Participants who complete all numeric pain rating scales
- •Patients aged ≥ 18 years old
排除标准
- •Participants who opt out of the study or withdraw consent
- •Participants who are determined to be without capacity to consent to study participation or injection procedure by principal investigator
- •Participants with inability to complete numeric pain rating scales
- •Participants with known allergies to triamcinolone acetonide, lidocaine, or bupivicaine
- •Participants without clinically diagnosed bilateral arthritis, tendinopathy, arthropathy, or compression neuropathy of the hand, wrist, or elbow.
- •Participants where treatment with corticosteroid injection is not indicated bilaterally.
- •Patients ≤ 18 years old
研究组 & 干预措施
Limb A: No Anesthesia and Limb B: Vapocoolant Spray Anesthesia
No anesthesia and vapocoolant spray topical anesthetic prior to injection. Participant will complete post-injection numeric pain rating scale assessing pain of injection.
Limb A: No Anesthesia and Limb B:Vibration Anesthesia (DigiVibe)
Limb A: no anesthesia and Limb B:vibration anesthesia using the Digivibe device throughout the duration of the injection. Vibratory anesthesia will be administered throughout the duration of the injection. The circular part of the device will be applied directly to the surface of the skin. At the center of the circle is where the injection will be given, and the vibration will be turned on throughout the duration of the injection. After typical disposal of injection syringe, participant will complete post-injection numeric pain rating scale assessing pain of injection.
干预措施: Digivibe Device (Device)
Limb A: Vapocoolant Spray Anesthesia Limb B: Vibration Anesthesia (DigiVibe)
Limb A: vapocoolant spray topical anesthetic prior to injection and Limb B: vibration anesthesia using the Digivibe device throughout the duration of the injection Vapocoolant spray anesthesia will be applied until the skin blanches, which is the standard clinical use. Corticosteroid injection will be given. After typical disposal of injection syringe, participant will complete post-injection numeric rating score.
干预措施: Digivibe Device (Device)
结局指标
主要结局
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Hand
时间窗: At time of injection (immediately following corticosteroid injection procedure)
Pain intensity will be assessed using a validated pain scale (e.g., 0-10 Numeric Rating Scale \[NRS\]) at the time of corticosteroid injection in the hand, wrist, or elbow. (0 being none 10 being worst possible pain)
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Elbow
时间窗: At time of injection (immediately following corticosteroid injection procedure)
Pain intensity will be assessed using a validated pain scale (e.g., 0-10 Numeric Rating Scale \[NRS\]) at the time of corticosteroid injection in the hand, wrist, or elbow. (0 being none 10 being worst possible pain)
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Wrist
时间窗: At time of injection (immediately following corticosteroid injection procedure)
Pain intensity will be assessed using a validated pain scale (e.g., 0-10 Numeric Rating Scale \[NRS\]) at the time of corticosteroid injection in hand, wrist, or elbow. (0 being none 10 being worst possible pain)
次要结局
- Change in Pain Intensity From Baseline to Injection in the Arm(Baseline (pre-injection) to time of injection)
- Change in Pain Intensity From Baseline to Injection in the Elbow(Baseline (pre-injection) to time of injection)
- Change in Pain Intensity From Baseline to Injection in the Wrist(Baseline (pre-injection) to time of injection)