Vibratory Anesthesia on Pain Following Corticosteroid Injections

The Effect of Vibratory Anesthesia on Patient Pain Perception in Corticosteroid Injections of the Upper Extremity

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.

Study Overview

• Status: Recruiting
• Conditions: Tendinopathy; Arthropathy; Compression Neuropathy; Bilateral Arthritis of Wrist; Bilateral Arthritis of Hands
• Intervention / Treatment: Device: Digivibe Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Faillace, MD,FAAOS; Phone Number: 409-772-1011; Email: jofailla@utmb.edu
• Study Contact Backup: Name: Alice Lee; Phone Number: 409-772-1011; Email: alklee@utmb.edu

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • Recruiting
      • University of Texas Medical Branch
      • Contact: Alice Lee; Phone Number: 409-772-1011; Email: alklee@utmb.edu
      • Contact: John Faillace, MD, FAAOS; Phone Number: (409)772-1011; Email: jofailla@utmb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity From Baseline to Injection in the Arm	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).	Baseline (pre-injection) to time of injection
Change in Pain Intensity From Baseline to Injection in the Elbow	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).	Baseline (pre-injection) to time of injection
Change in Pain Intensity From Baseline to Injection in the Wrist	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).	Baseline (pre-injection) to time of injection

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pain in Hand; Pain in Elbow; Pain in Wrist
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Joint Diseases; Tendinopathy; Tomaculous neuropathy
• Other Study ID Numbers: 24-0303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes