Bilateral Arthritis of WristNCT07553273
Vibratory Anesthesia on Pain Following Corticosteroid Injections
A study testing Digivibe Device in people with Bilateral Arthritis of Wrist and Tendinopathy, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bilateral Arthritis of Wrist, Tendinopathy, Arthropathy
- What is being tested?
- Digivibe Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Alice Lee, 409-772-1011, alklee@utmb.edu
John Faillace, MD, FAAOS, (409)772-1011, jofailla@utmb.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Bilateral Arthritis of Wrist, Tendinopathy, Arthropathy, Compression Neuropathy, Bilateral Arthritis of Hands
- Being tested
- Digivibe Device
- Keywords
- Pain in Hand, Pain in Elbow, Pain in Wrist
- Medical subject headings
- Tendinopathy, Joint Diseases, Tomaculous neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digivibe DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Digivibe Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: At time of injection (immediately following corticosteroid injection procedure)
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: Baseline (pre-injection) to time of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start14 Jan 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Arthritis of WristStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553273
- Sponsor's protocol ID
- 24-0303
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vibratory Anesthesia on Patient Pain Perception in Corticosteroid Injections of the Upper Extremity
- ClinicalTrials.gov ID
- NCT07553273
- Acronym / sponsor ID
- 24-0303
- Conditions
- Bilateral Arthritis of Wrist, Tendinopathy, Arthropathy, Compression Neuropathy, Bilateral Arthritis of Hands
- Keywords
- Pain in Hand, Pain in Elbow, Pain in Wrist
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Digivibe DeviceLimb 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. |
| Limb A: Vapocoolant Spray Anesthesia Limb B: Vibration Anesthesia (DigiVibe) | Experimental | Device: Digivibe DeviceLimb 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digivibe DeviceThe 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. | Device | Limb A: No Anesthesia and Limb B:Vibration Anesthesia (DigiVibe), Limb A: Vapocoolant Spray Anesthesia Limb B: Vibration Anesthesia (DigiVibe) |
Primary outcome
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Hand
Time frame: At time of injection (immediately following corticosteroid injection procedure)
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)
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Elbow
Time frame: At time of injection (immediately following corticosteroid injection procedure)
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)
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Wrist
Time frame: At time of injection (immediately following corticosteroid injection procedure)
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)
3 secondary outcomes
Change in Pain Intensity From Baseline to Injection in the Arm
Time frame: Baseline (pre-injection) to time of injection
Change in Pain Intensity From Baseline to Injection in the Elbow
Time frame: Baseline (pre-injection) to time of injection
Change in Pain Intensity From Baseline to Injection in the Wrist
Time frame: Baseline (pre-injection) to time of injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digivibe Device in people with Bilateral Arthritis of Wrist and Tendinopathy, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Faillace, MD,FAAOS (409-772-1011, jofailla@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.