Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia

12 de agosto de 2021 actualizado por: Ioannis Tassiulas, Icahn School of Medicine at Mount Sinai

Vestibular Caloric Stimulation and the Modulation of Pain in Fibromyalgia: An Open Label Pilot Study

The management of chronic pains is challenging and fraught with limitations. Fibromyalgia is a common pain disorder characterized by chronic widespread pains, associated with fatigue and impaired quality of life. Fibromyalgia affects millions of people and is among the most common reasons for consulting with a rheumatologist. The food and drug administration (FDA) approved three medications to treat fibromyalgia, though there are many patients for whom these medications are ineffective, poorly tolerated or cost-prohibitive. Accordingly, there exists a need for novel therapeutics.

The researchers would like to test the therapeutic efficacy of a non-pharmacologic non-interventional bedside technique called vestibular caloric stimulation (VCS). VCS, irrigating the external ear canal with water, is a simple, non-invasive, cost-free procedure with preliminary data suggesting potential for improving pain. VCS is a form of neuromodulation and there are anatomically defined pathways elucidated to help explain how this works. There currently exists limited data on the topic, only case reports and case series. Given a clear need for additional therapeutics in many patients with fibromyalgia, the researchers have elected to conduct this trial.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

This is an open label pilot study testing the potential therapeutic efficacy of vestibulocortical stimulation via cold water calorics in fibromyalgia. The trial will entail 6 weeks of total involvement for each participant including 3 weeks of active participation, with 4 weeks follow up: the irrigation happens at the beginning of week 2, so 4 weeks later is week 6.

Tipo de estudio

Intervencionista

Inscripción (Actual)

21

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New York
      • New York, New York, Estados Unidos, 10029
        • Icahn School of Medicine at Mount Sinai

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • At least 18 years old with ability to comprehend and consent to protocol.
  • Diagnosis of fibromyalgia by American College of Rheumatology (ACR) criteria (questionnaire).
  • At least a 4/10 baseline on the visual analogue pain scale (VAS).
  • Stable fibromyalgia medications for at least 4 weeks.
  • Owns or has access to a smart phone or computer to complete outcome measures.

Exclusion Criteria:

  • Use of opioids
  • Otitis externa or media within the past six months.
  • Current ear pain with or without other symptoms of otitis externa.
  • History of tympanic membrane rupture or surgery.
  • Current pregnancy.
  • Inability to lay supine for 30 minutes.
  • Limited decision making capacity.
  • Engaged in litigation, currently or prior, related to FMS.
  • Inability to commute to clinic once.
  • Primary language not English.
  • Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study
  • Treatment with the medication meclizine for vertigo
  • History of seizures
  • Diagnosis of bipolar disorder (treated or untreated)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cold water caloric stimulation
50 cc of ice-cold water irrigation into the right ear at 1-2 cc/second, once per participant.
Irrigation of the right external ear canal
Otros nombres:
  • VCS
  • Cold water caloric stimulation

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Numeric Rating Scale (NRS)
Periodo de tiempo: baseline and 1 week after VCS
Change in average diary pain scores assessed by daily report on a 11 point numeric rating scale at 1 week after VCS as compared to baseline. Full scale range from 0-10, higher score indicates more pain.
baseline and 1 week after VCS

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Acute change in NRS
Periodo de tiempo: baseline and 5, 15 and 30 minutes after VCS
Acute effect of VCS assessed by acute change in pain scores post VCS 5, 15 and 30 minutes post irrigation compared to baseline. Full scale range from 0-10, higher score indicates more pain.
baseline and 5, 15 and 30 minutes after VCS
Percentage of participants with NRS pain scores >= to 30% and 50%
Periodo de tiempo: 30 minutes, 24 hours, 1 week, 2 weeks after VCS
Percentage of patients with change in pain assessed by NRS pain scores > or equal to 30% and 50%.
30 minutes, 24 hours, 1 week, 2 weeks after VCS
Patient Global Impression of Change (PGIC)
Periodo de tiempo: at 1 weeks, 2 weeks and 4 weeks after VCS
Full score from 0-7, with higher score indicating more improvement.
at 1 weeks, 2 weeks and 4 weeks after VCS
Change in Multidimensional Assessment of Fatigue (MAF)
Periodo de tiempo: baseline and at 1, 2 and 4 weeks after VCS
MAF is a 16 item instrument, full scale from 0-50, with higher score indicating more fatigue.
baseline and at 1, 2 and 4 weeks after VCS
Michigan Neuropathy Screening Instrument (MNSI)
Periodo de tiempo: baseline and at 1, 2 and 4 weeks after VCS
15 "yes or no" questions - full score from 0-13, with higher score indicating more neuropathic symptoms.
baseline and at 1, 2 and 4 weeks after VCS
Change in Brief Pain Inventory Short Form 36 (BPI SF36)
Periodo de tiempo: baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
A 9-item instrument with total score from 0 to 10, with higher score indicating worse outcomes. Will exclude question 2 which is a diagram and question 7 which asks about medications.
baseline and at 24 hours, 1 week, 2 weeks, 4 weeks after VCS
Change in Fibromyalgia Impact Questionnaire (FIQ)
Periodo de tiempo: baseline and at 1, 2 and 4 weeks after VCS
Full scale from 0-100, with higher score indicating a greater impact of fibromyalgia syndrome.
baseline and at 1, 2 and 4 weeks after VCS
Change in Numeric Rating Scale (NRS) for pain in different regions of the body
Periodo de tiempo: baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
Pain measured on a numeric rating scale in different regions of the body: the left upper extremity, right upper extremity, left lower extremity, right lower extremity, front of torso, back of torso, head/neck. Full scale range from 0-10, higher score indicates more pain.
baseline and at 24 hours, 1 week, 2 week, 4 week after VCS
VCS Tolerability Survey
Periodo de tiempo: 24 hours post VCS
A seventeen question tolerability instrument developed specifically for caloric stimulation to assess tolerability by measuring the frequency and intensity of headaches, nausea, and vertigo. the tolerability scale does not have a total score just individual questions re headache nausea vertigo discomfort and grades intensities rated on a 0-10 scale, higher numbers reflecting higher severity of symptoms.
24 hours post VCS
Number of participants willing to trial VCS again
Periodo de tiempo: 24 hours post VCS
Number of participants expressing willingness to trial VCS again
24 hours post VCS
Change in Subjective Overall Well Being Scale
Periodo de tiempo: at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative
Subjective Overall Well Being Scale is a 11 point scale with full scale from 0-10, with higher score reflecting the best possible overall subjective disposition
at baseline and at 30 minutes after VCS, 24 hours, 1 week, 2 week and 4 weeks after VCS relative

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Ioannis Tassiulas, MD, Icahn School of Medicine at Mount Sinai

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

19 de marzo de 2021

Finalización primaria (Actual)

2 de julio de 2021

Finalización del estudio (Actual)

2 de julio de 2021

Fechas de registro del estudio

Enviado por primera vez

9 de agosto de 2021

Primero enviado que cumplió con los criterios de control de calidad

9 de agosto de 2021

Publicado por primera vez (Actual)

13 de agosto de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de agosto de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

12 de agosto de 2021

Última verificación

1 de agosto de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Suscribir