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Vibrationsanæstesi mod smerte efter kortikosteroidinjektioner

29. oktober 2026 opdateret af: The University of Texas Medical Branch, Galveston

Effekten af vibrationsanæstesi på patienters smerteopfattelse ved kortikosteroidinjektioner i overekstremiteten

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

165

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: John Faillace, MD,FAAOS
  • Telefonnummer: 409-772-1011
  • E-mail: jofailla@utmb.edu

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Texas
      • Galveston, Texas, Forenede Stater, 77555
        • Rekruttering
        • University of Texas Medical Branch
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
Enhed: 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.
Eksperimentel: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Hand
Tidsramme: 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)
At time of injection (immediately following corticosteroid injection procedure)
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Elbow
Tidsramme: 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)
At time of injection (immediately following corticosteroid injection procedure)
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Wrist
Tidsramme: 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)
At time of injection (immediately following corticosteroid injection procedure)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain Intensity From Baseline to Injection in the Arm
Tidsramme: Baseline (pre-injection) to time of injection

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
Tidsramme: Baseline (pre-injection) to time of injection

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
Tidsramme: Baseline (pre-injection) to time of injection

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Medical Branch, Galveston

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. januar 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

21. april 2026

Først opslået (Faktiske)

27. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 24-0303

Plan for individuelle deltagerdata (IPD)

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