About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Digivibe Device
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Pain 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)
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)
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)
Secondary outcomes
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).
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).
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).
Sponsors and contacts
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