Vibratory Anesthesia on Pain Following Corticosteroid Injections
Purpose
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.
Conditions
- Bilateral Arthritis of Wrist
- Tendinopathy
- Arthropathy
- Compression Neuropathy
- Bilateral Arthritis of Hands
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Any patient of the Principal Investigator, Dr. John Faillace, 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Arm 1 |
No anesthesia and vapocoolant spray topical anesthetic prior to injection. Participant will complete post-injection numeric pain rating scale assessing pain of injection. |
|
|
Experimental Arm 2 |
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. |
|
|
Experimental Arm 3 |
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. |
|
Recruiting Locations
Galveston, Texas 77555
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Medical Branch, Galveston
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.