Arthropathy, Bilateral Arthritis of Hands, Bilateral Arthritis of Wrist, Compression Neuropathy, Tendinopathy
Conditions
Keywords
Pain in Hand, Pain in Elbow, Pain in Wrist
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDigivibe 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.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Hand | 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 | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity From Baseline to Injection in the Arm | Baseline (pre-injection) to time of injection | 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 | Baseline (pre-injection) to time of injection | 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 | Baseline (pre-injection) to time of injection | 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). |
Countries
United States
Contacts
CONTACTJohn Faillace, MD,FAAOS
CONTACTAlice Lee
Outcome results
None listed