Anestesia Vibratória na Dor Após Injeções de Corticosteroides
O Efeito da Anestesia Vibratória na Perceção de Dor do Paciente em Injeções de Corticosteroides na Extremidade Superior
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: John Faillace, MD,FAAOS
- Número de telefone: 409-772-1011
- E-mail: jofailla@utmb.edu
Estude backup de contato
- Nome: Alice Lee
- Número de telefone: 409-772-1011
- E-mail: alklee@utmb.edu
Locais de estudo
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Texas
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Galveston, Texas, Estados Unidos, 77555
- Recrutamento
- University of Texas Medical Branch
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Contato:
- Alice Lee
- Número de telefone: 409-772-1011
- E-mail: alklee@utmb.edu
-
Contato:
- John Faillace, MD, FAAOS
- Número de telefone: (409)772-1011
- E-mail: jofailla@utmb.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: 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. |
|
|
Experimental: 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. |
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. |
|
Experimental: 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. |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Hand
Prazo: 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
Prazo: 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
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Pain Intensity From Baseline to Injection in the Arm
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 24-0303
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