Recruiting

Corticosteroid Injection

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT07553273

Conditions

Bilateral Arthritis of Wrist

Tendinopathy

Arthropathy

Compression Neuropathy

Bilateral Arthritis of Hands

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digivibe Device

Study Details

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.

Conditions

Bilateral Arthritis of Wrist

Tendinopathy

Arthropathy

Compression Neuropathy

Bilateral Arthritis of Hands

Study ID

NCT07553273

Start date

Jan 14, 2026

Status verified date

Jul, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Digivibe 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.

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

Central Contacts and Locations

Central contacts

John Faillace, MD,FAAOS

409-772-1011jofailla@utmb.edu

Alice Lee

409-772-1011alklee@utmb.edu

Locations

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Alice Lee

409-772-1011alklee@utmb.edu

John Faillace, MD, FAAOS

(409)772-1011jofailla@utmb.edu

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Pain in Hand
  • Pain in Elbow
  • Pain in Wrist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2026-07-10.