Vibratory Anesthesia on Pain Following Corticosteroid Injections

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Medical Branch, Galveston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: Limb A: No Anesthesia and Limb B: Vapocoolant Spray AnesthesiaNo intervention 0 interventions
Group B: Limb A: No Anesthesia and Limb B:Vibration Anesthesia (DigiVibe)Experimental treatment 1 intervention
Group C: Limb A: Vapocoolant Spray Anesthesia Limb B: Vibration Anesthesia (DigiVibe)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)

Secondary outcomes

1

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
2

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
3

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

Other outcomes

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