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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
165
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.
University of Texas Medical Branch
Galveston, Texas, United States
RECRUITINGPain Intensity During Corticosteroid Injection With Topical Anesthesia in the Hand
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)
Time frame: At time of injection (immediately following corticosteroid injection procedure)
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Elbow
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)
Time frame: At time of injection (immediately following corticosteroid injection procedure)
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Wrist
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)
Time frame: At time of injection (immediately following corticosteroid injection procedure)
Change in Pain Intensity From Baseline to Injection in the Arm
Change in participant-reported pain intensity will be calculated as the difference between baseline pain (prior to injection) and pain during injection using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Scores will be compared across intervention groups (vibratory anesthesia, vapocoolant spray anesthesia, and no anesthesia).
Time frame: Baseline (pre-injection) to time of injection
Change in Pain Intensity From Baseline to Injection in the Elbow
Change in participant-reported pain intensity will be calculated as the difference between baseline pain (prior to injection) and pain during injection using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Scores will be compared across intervention groups (vibratory anesthesia, vapocoolant spray anesthesia, and no anesthesia).
Time frame: Baseline (pre-injection) to time of injection
Change in Pain Intensity From Baseline to Injection in the Wrist
Change in participant-reported pain intensity will be calculated as the difference between baseline pain (prior to injection) and pain during injection using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Scores will be compared across intervention groups (vibratory anesthesia, vapocoolant spray anesthesia, and no anesthesia).
Time frame: Baseline (pre-injection) to time of injection
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