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

The Use of Ultrasound to Quantify Muscle Overlying the Carpal Tunnel

24 de enero de 2018 actualizado por: Clalit Health Services

Carpal tunnel syndrome (CTS) is a common condition that still lacks a reliable, objective screening test. Many anatomical aspects of the syndrome have been studied including the dimensions of the carpal tunnel and shape of the nerve within the tunnel. The investigators have observed varying amounts of muscle overlying the carpal tunnel in patients undergoing surgery for the condition. Assuming that this muscle may have a dynamic role in the development of the condition, the investigators attempted to quantify this muscle using ultrasound (US).

The purpose of this study was to devise a technique to evaluate the amount of muscle overlying the carpal tunnel.

The hypothesis is that patients with carpal tunnel syndrome will have significantly more muscle overlying the carpal tunnel than individuals without carpal tunnel syndrome.

Descripción general del estudio

Estado

Retirado

Descripción detallada

Introduction:

The pathophysiology of carpal tunnel syndrome (CTS) is in all probability multifactorial including many parameters that ultimately increase the pressure within the carpal tunnel. It is likely that the increased pressure then causes injury to the median nerve and the signs and symptoms of CTS. The relationship between the size or dimensions of the hand and the occurrence of CTS has been evaluated and "square-shaped" hands have also been examined to determine if there is an increased tendency to develop CTS. The literature remains inconclusive at this time. Other static anatomical parameters that have been evaluated include the size of the carpal tunnel and the thickness and biomechanical properties of the transverse carpal ligament again without absolute consensus in the literature.

Additional studies have evaluated the role of the intrinsic musculature within and surrounding the carpal tunnel in the etiology of CTS. Most of these studies have evaluated the muscles as space occupying lesions that add to the pressure within the carpal tunnel. The investigators believe that some of the muscles described, specifically those that are found within the transverse carpal ligament and that cross the area of the carpal tunnel, actually have a dynamic role in the etiology of CTS, especially in manual laborers that use their hands in a forceful manner in a repetitive fashion. It is also possible that this anatomic variant (muscles crossing the area of the carpal tunnel) is related to the "square "hand configuration and that this dynamic contribution to the pressure within the carpal tunnel is the reason for the increased incidence of CTS in these patients. The purpose of this study is to quantify the amount of muscle crossing the area of the carpal tunnel in normal individuals and to compare it to the amount of muscle in the wrists of patients with CTS.

Hypothesis: Participants with CTS will have more muscle crossing the carpal tunnel that normal controls (without CTS).

Purpose: To compare the amount of muscle crossing the carpal tunnel in normal controls (without CTS) and in patients with CTS

Specific aims:

  1. To develop a system to quantify the amount of muscle crossing the carpal tunnel area using ultrasound of the wrist area.
  2. To compare this measurement in normal wrists and in wrists with CTS
  3. To compare the measurements in the CTS patients to intraoperative evaluation of the amount of muscle crossing the carpal tunnel area .
  4. To compare these measurements to the external measurements of the hand (palm width/palm length)

Methods:

Fifty participants will be recruited for the study. Twenty five participants with no CTS- and twenty five with CTS.

The CTS group inclusion criteria:

The diagnosis of CTS will include:

  1. Signs and symptoms of CTS: nighttime numbness and tingling or numbness and tingling in a median nerve distribution with a positive phalen or tinel or forearm compression test
  2. A nerve conduction test and electromyography (NCT and EMG) that is positive for CTS.

The participants without CTS inclusion criteria:

1) Individuals that do not have any signs and or symptoms of CTS.

Exclusion criteria:

  1. Individuals that have a known history of peripheral neuropathy or other condition in the hand including recent significant trauma.
  2. Patients with incomplete or unclear evaluation and tests.
  3. Individuals unwilling to sign a consent form to participate in the study.

Patients that meet the inclusion criteria and that are sent for carpal tunnel release surgery will be consented and examined on the day of surgery. Their US results, external palmar measurements as well as the amount of overlying muscle will be recorded as well as demographic data. Demographic information, occupational history, history of hand diagnoses and procedures as well as history pertinent to CTS (nighttime numbness and tingling, pain, perceived pinch weakness, and duration of symptoms) will be collected. Results of nerve conduction testing (NCT) will be recorded.

Physical examination findings pertinent to CTS will be collected including pinch strength, grip strength, 2-point discrimination, and the hand measurements of palm width (PW), palm length (PL).

External measurements: PL is measured as the vertical length from the midline of the distal wrist crease to the proximal middle finger. PW is measured as the horizontal length from the base of the 1st metacarpophalangeal (MP) joint along the proximal palmar crease.

Tipo de estudio

De observación

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

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Patients with the diagnosis of CTS and those without

Descripción

Inclusion Criteria:

  • The diagnosis of CTS will include signs and symptoms of CTS: nighttime numbness and tingling or numbness and tingling in a median nerve distribution with a positive phalen or tinel or forearm compression test as well as a nerve conduction test and electromyography (NCT and EMG) that is positive for CTS.
  • The normal subjects: individuals that do not have any signs and or symptoms of CTS.

Exclusion Criteria:

  • Patients or individuals that have a known history of peripheral neuropathy or other condition in the hand including recent significant trauma.
  • Patients with incomplete or unclear evaluation and tests.
  • Individuals unwilling to sign a consent form to participate in the study.

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

Cohortes e Intervenciones

Grupo / Cohorte
carpal tunnel syndrome
No intervention
normals
no intervention

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
amount-depth of muscle overlying the carpal tunnel
Periodo de tiempo: 2 years
As determined by ultrasound
2 years

Colaboradores e Investigadores

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

Patrocinador

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

1 de julio de 2016

Finalización primaria (Anticipado)

1 de julio de 2018

Finalización del estudio (Anticipado)

1 de julio de 2018

Fechas de registro del estudio

Enviado por primera vez

16 de agosto de 2015

Primero enviado que cumplió con los criterios de control de calidad

16 de febrero de 2016

Publicado por primera vez (Estimar)

17 de febrero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de enero de 2018

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

24 de enero de 2018

Última verificación

1 de julio de 2015

Más información

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