Vibratory Anesthesia on Pain Following Corticosteroid Injections

Официальное название

The Effect of Vibratory Anesthesia on Patient Pain Perception in Corticosteroid Injections of the Upper Extremity

Обзор

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.

Подробное описание

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.

Both corticosteroid injections are administered as part of routine clinical care. The use of topical anesthetic and/or vibratory anesthesia is performed solely for research purposes. The total duration of the study visit is approximately 20 minutes.

Вмешательства

• Устройство Digivibe Device
  The Digivibe device uses pulsed vibrations to activate larger nerve fibers to interfere with pain signals. It has a circular shape to allow for injections in an area surrounded by pain-blocking vibrations.

Первичные конечные точки

• Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Hand [Срок оценки: At time of injection (immediately following corticosteroid injection procedure)]
• Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Elbow [Срок оценки: At time of injection (immediately following corticosteroid injection procedure)]
• Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Wrist [Срок оценки: At time of injection (immediately following corticosteroid injection procedure)]

Вторичные конечные точки (3)

• Change in Pain Intensity From Baseline to Injection in the Arm [Срок оценки: Baseline (pre-injection) to time of injection]
• Change in Pain Intensity From Baseline to Injection in the Elbow [Срок оценки: Baseline (pre-injection) to time of injection]
• Change in Pain Intensity From Baseline to Injection in the Wrist [Срок оценки: Baseline (pre-injection) to time of injection]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Texas Medical Branch — Galveston

Идентификаторы

NCT: NCT07553273 · 24-0303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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