Vibratory Anesthesia on Pain Following Corticosteroid Injections

Part of paid clinical trials in Galveston, Texas.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT07553273
Status
Recruiting
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Conditions

  • Arthropathy
  • Bilateral Arthritis of Hands
  • Bilateral Arthritis of Wrist
  • Compression Neuropathy
  • Tendinopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Digivibe Device — 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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Limb A: No Anesthesia and Limb B: Vapocoolant Spray Anesthesia
    No anesthesia and vapocoolant spray topical anesthetic prior to injection. Participant will complete post-injection numeric pain rating scale assessing pain of injection.
  • Experimental: Limb A: No Anesthesia and Limb B:Vibration Anesthesia (DigiVibe)
    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: Limb A: Vapocoolant Spray Anesthesia Limb B: Vibration Anesthesia (DigiVibe)
    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.

Primary Outcome Measure

Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Hand [ Time Frame: At time of injection (immediately following corticosteroid injection procedure) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Medical BranchGalvestonTexas77555
Alice Lee
[email protected]
409-772-1011
John Faillace, MD, FAAOS
[email protected]
(409)772-1011

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