Vibratory Anesthesia on Pain Following Corticosteroid Injections

NCT07553273 | Recruiting FDA Device

• 1 other identifier: 24-0303
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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

Keywords

Pain in Hand; Pain in Elbow; Pain in Wrist

Outcome Measures

Primary Outcomes (3)

• 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)

  At time of injection (immediately following corticosteroid injection procedure)

• 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)

  At time of injection (immediately following corticosteroid injection procedure)

• 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)

  At time of injection (immediately following corticosteroid injection procedure)

Secondary Outcomes (3)

• Change in Pain Intensity From Baseline to Injection in the Arm

  Baseline (pre-injection) to time of injection

• Change in Pain Intensity From Baseline to Injection in the Elbow

  Baseline (pre-injection) to time of injection

• Change in Pain Intensity From Baseline to Injection in the Wrist

  Baseline (pre-injection) to time of injection

Study Arms (3)

Limb A: No Anesthesia and Limb B: Vapocoolant Spray Anesthesia

NO INTERVENTION

No anesthesia and vapocoolant spray topical anesthetic prior to injection. Participant will complete post-injection numeric pain rating scale assessing pain of injection.

Limb A: No Anesthesia and Limb B:Vibration Anesthesia (DigiVibe)

EXPERIMENTAL

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.

Device: Digivibe Device

Limb A: Vapocoolant Spray Anesthesia Limb B: Vibration Anesthesia (DigiVibe)

EXPERIMENTAL

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.

Device: Digivibe Device

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.

Limb A: No Anesthesia and Limb B:Vibration Anesthesia (DigiVibe); Limb A: Vapocoolant Spray Anesthesia Limb B: Vibration Anesthesia (DigiVibe)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Tendinopathy; Joint Diseases; Tomaculous neuropathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Central Study Contacts

John Faillace, MD,FAAOS

CONTACT

409-772-1011; jofailla@utmb.edu

Alice Lee

CONTACT

409-772-1011; alklee@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)