Anestesia vibratoria y el dolor tras inyecciones de corticoides
El Efecto de la Anestesia Vibratoria en la Percepción del Dolor del Paciente en Inyecciones de Corticosteroides en la Extremidad 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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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 estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: John Faillace, MD,FAAOS
- Número de teléfono: 409-772-1011
- Correo electrónico: jofailla@utmb.edu
Copia de seguridad de contactos de estudio
- Nombre: Alice Lee
- Número de teléfono: 409-772-1011
- Correo electrónico: alklee@utmb.edu
Ubicaciones de estudio
-
-
Texas
-
Galveston, Texas, Estados Unidos, 77555
- Reclutamiento
- University of Texas Medical Branch
-
Contacto:
- Alice Lee
- Número de teléfono: 409-772-1011
- Correo electrónico: alklee@utmb.edu
-
Contacto:
- John Faillace, MD, FAAOS
- Número de teléfono: (409)772-1011
- Correo electrónico: jofailla@utmb.edu
-
-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Intensity During Corticosteroid Injection With Topical Anesthesia in the Hand
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Pain Intensity From Baseline to Injection in the Arm
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 24-0303
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .