An interventional study of Digivibe Device in Bilateral Arthritis of Wrist, Tendinopathy and Arthropathy, sponsored by The University of Texas Medical Branch, Galveston. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Supportive care
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.
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.
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
This study's planned enrollment of 165 is above the median of 48 across 332 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 257 studies on the registry; 38 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
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)
Time frame: 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)
Time frame: 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)
Time frame: At time of injection (immediately following corticosteroid injection procedure)
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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline (pre-injection) to time of injection
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jan 2026 (actual). Primary completion is estimated for Apr 2027, 15 months after the start.
Of 174 non-industry interventional studies with no phase under Tendinopathy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 15 months is below that.
Counting every sponsor, half of 183 studies reached it within 20 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Texas Medical Branch, Galveston →