Vibratory Anesthesia on Pain Following Corticosteroid Injections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digivibe Device.
- Who it may be relevant to
- Registry conditions: Bilateral Arthritis of Wrist, Tendinopathy, Arthropathy, Compression Neuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Vibratory Anesthesia on Patient Pain Perception in Corticosteroid Injections of the Upper Extremity
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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)]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Texas Medical Branch — Galveston
Identifiers
NCT: NCT07553273 · 24-0303