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Measurement of Muscle Strength Using a Manual Muscle Tester in Women With Electrophysiologically Confirmed Carpal Tunnel Syndrome

28 de septiembre de 2026 actualizado por: Bezmialem Vakif University

The aim of this cross-sectional study is to evaluate muscle strength in female patients with carpal tunnel syndrome (CTS) who have only sensory involvement detected on electromyography. Muscle strength will be assessed using the "Lafayette Manual Muscle Tester®".

The main questions of the study are:

  1. Is there a difference in muscle strength between healthy individuals and female patients with carpal tunnel syndrome?
  2. Is there a difference in muscle strength between female patients with carpal tunnel syndrome who have only sensory involvement and those who have both sensory and motor involvement?
  3. Are there differences in the strength of thumb palmar abduction and adduction, radial adduction and abduction, thumb flexion, extension and opposition, and flexion of the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the fingers between these groups?

The investigators will measure the muscle strength associated with these movements using the "Lafayette Manual Muscle Tester®" in order to objectively evaluate motor involvement in female patients with carpal tunnel syndrome and to compare muscle strength between healthy individuals and patients with different degrees of electrophysiological involvement.

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and develops as a result of compression of the median nerve within the carpal tunnel at the level of the wrist. It manifests with pain in the wrist and hand, paresthesia and sensory loss in the dermatome of the median nerve in the hand (paresthesias may sometimes extend to the entire hand and even the arm), as well as weakness in thumb abduction, opposition, and flexion, and flexion of the second and third fingers at the metacarpophalangeal joints. The carpal tunnel is a structure located in the proximal palmar region of the wrist, bounded superiorly by connective tissue and the carpal ligament and inferiorly by the carpal bones, through which the median nerve and flexor tendons pass. The motor fibers of the median nerve passing through the carpal tunnel innervate the thenar muscle group (abductor pollicis brevis, flexor pollicis brevis-superficial head, and opponens pollicis), as well as the first and second lumbrical muscles; its sensory fibers provide innervation to the first three digits and the lateral aspect of the fourth digit

Among the risk factors for this common entrapment neuropathy are female sex, obesity, age, occupations and activities involving repetitive rotational and flexion movements of the hand, trauma, and pregnancy . The diagnosis of CTS is primarily clinical. It is established based on typical signs and symptoms, such as hand and wrist pain, symptoms occurring or worsening at night, relief with shaking of the hand, and positive Tinel and Phalen signs. Electrophysiological studies (nerve conduction studies and needle electromyography) are used both to confirm the diagnosis of CTS and to exclude other conditions included in the differential diagnosis, such as polyneuropathy, hereditary neuropathy with liability to pressure palsies, and C6 radiculopathy. Nerve ultrasonography (US) is also valuable for demonstrating compression of the median nerve within the carpal tunnel and can additionally identify other lesions affecting the nerve at this level, such as a ganglion cyst .

Although patients with CTS may not have overt motor involvement, clumsiness and impairment of fine motor functions are frequently observed. It has been suggested that these findings may result from impaired sensory feedback required for motor coordination or from a central sensory-motor integration disorder

Changes in muscle strength in patients with sensory involvement only on electromyography can be measured precisely using hand-held dynamometers . Hand-held dynamometers have long been used for the objective assessment of muscle strength. In recent years, electronic versions of these devices have been developed. In our study, muscle strength will be objectively assessed using the "Lafayette Manual Muscle Tester®" by measuring the force exerted by the relevant muscle group during isometric contraction against the measurement pad of the device. Quantitative parameters, including peak force, mean force, and time-dependent changes in force, will be obtained.

Tipo de estudio

De observación

Inscripción (Estimado)

42

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.

Estudio Contacto

  • Nombre: Ozan Volkan Yurdakul, Prof.
  • Número de teléfono: +902124530453
  • Correo electrónico: yurdakul_ozan@yahoo.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Fatih
      • Istanbul, Fatih, Turquía (Türkiye), 34093
        • Bezmialem Vakif University
        • Contacto:
        • Contacto:

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

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

Patients who applied to the Bezmialem Vakıf University, Neurology Outpatient Clinic appropriate for eligibility criteria will be enrolled

Descripción

Inclusion Criteria:

  • Age ≥18 years.
  • Female sex.
  • Unilateral or bilateral carpal tunnel syndrome according to the Boston Carpal Tunnel Syndrome criteria.
  • Sensory or motor involvement on electromyography (EMG).
  • Paresthesia, pain, or numbness in the area of the hand innervated by the median nerve for more than 3 months.
  • Presence of Tinel's and Phalen's signs.

Exclusion Criteria:

  • History of hand surgery.
  • Severe cardiovascular disease.
  • Neuromuscular disease affecting muscle strength.
  • Gout.
  • History of hand trauma.
  • History of rheumatoid arthritis or osteoarthritis of the hand or wrist.
  • Pregnancy.
  • Cervical radiculopathy or any upper extremity neuropathy other than carpal tunnel syndrome.

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

  • Modelos observacionales: CASE_CONTROL
  • Perspectivas temporales: CROSS_SECTIONAL

Cohortes e Intervenciones

Grupo / Cohorte
CTS-affected hand

Participants with unilateral or bilateral carpal tunnel syndrome according to the Boston Carpal Tunnel Syndrome criteria will be admitted to this group.

Median and ulnar sensory and motor nerve conduction studies will be performed in both upper extremities.

The comparison of the peak latency of the median and ulnar sensory responses with fourth-finger stimulation will be performed.

Needle electromyography will be performed when necessary to exclude radiculopathy.

Muscle strength of thumb palmar abduction, radial abduction, thumb flexion, extension and opposition, and proximal and distal interphalangeal joint flexion of the fingers will be evaluated using a hand-held dynamometer (Lafayette Manual Muscle Tester®).

Healthy Control Group

Participants without carpal tunnel syndrome will be included in this group. Muscle strength of thumb palmar abduction, radial abduction, thumb flexion, extension and opposition, and proximal and distal interphalangeal joint flexion of the fingers will be evaluated using a hand-held dynamometer (Lafayette Manual Muscle Tester®).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
Periodo de tiempo: 1 day

A questionnaire consisting of 11 questions assessing symptom severity and 8 questions assessing functional status. Higher scores indicate greater disease severity. The Turkish version of the questionnaire has demonstrated validity and reliability. Numerical Rating Scale (NRS), A scale in which patients rate their pain on a numerical scale from 0 to 10. Higher scores indicate greater pain intensity.

1 day
Phalen Test
Periodo de tiempo: 1 day

The patient is asked to flex both wrists and hold the dorsal surfaces of the hands together for 60 seconds. The test is considered positive if pain or paresthesia occurs in the areas innervated by the median nerve, including the thumb, second and third fingers, the radial half of the fourth finger, or the forearm.

1 day
Durkan Test
Periodo de tiempo: 1 day

The patient's forearm is placed in supination, and pressure is applied over the median nerve between the thenar and hypothenar eminences for 30 seconds. The test is considered positive if paresthesia or pain is experienced.

1 day
Tinel Test
Periodo de tiempo: 1 day

In the symptomatic hand, the distal portion of the palmaris longus tendon near the palmar aspect of the wrist is gently percussed with a neurological reflex hammer. The test is considered positive if paresthesia or pain is experienced.

1 day
Electrophysiological Tests
Periodo de tiempo: 1 day

Median and ulnar sensory and motor nerve conduction studies will be performed in both upper extremities. The peak latency of the median and ulnar sensory responses with fourth-finger stimulation will be compared. Needle electromyography will be performed when necessary to exclude radiculopathy.1

1 day
Thumb Palmar Abduction
Periodo de tiempo: 1 day

The hand will be stabilized with the dorsal surface facing the table. The thumb will be positioned in maximum palmar abduction, perpendicular to the plane of the palm. The measurement pad of the device will be placed on the radial aspect of the proximal phalanx of the thumb. The patient will be instructed to push against the measurement pad with maximum force.Thumb Palmar Abduction Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Thumb Radial Abduction Muscle Strength
Periodo de tiempo: 1 day

The forearm will be positioned in supination with the palm facing upward. The patient will be instructed to move the thumb away from the palm in the radial direction. The measurement pad will be placed against the radial aspect of the proximal phalanx of the thumb, and the patient will be instructed to perform maximal radial abduction against the pad. Radial Abduction Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Thumb Extension Muscle Strength
Periodo de tiempo: 1 day

The hand will be stabilized with the dorsal surface facing the table, and the patient will be asked to lift the thumb upward in the sagittal plane. The measurement pad will be positioned against the radial aspect of the distal phalanx of the thumb, and the patient will be instructed to push against the pad with maximum force. Thumb Extension Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Thumb Opposition Muscle Strength
Periodo de tiempo: 1 day

The measurement device will be placed in the palm, with the measurement pad positioned at the level of the fifth finger. The patient will be instructed to perform thumb opposition and push against the measurement pad with maximum force. Thumb Opposition Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Thumb IP Flexion Muscle Strength
Periodo de tiempo: 1 day

The measurement device will be stabilized on a flat surface while the patient performs flexion of the thumb interphalangeal (IP) joint. The patient will be instructed to press the fingertip against the measurement pad with maximum force. Thumb IP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Thumb MCP Flexion Muscle Strength
Periodo de tiempo: 1 day

The measurement device will be placed in the palm, with the measurement pad positioned over the third metacarpophalangeal (MCP) joint. The patient will be instructed to perform thumb MCP flexion and push against the measurement pad with maximum force.Thumb MCP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Second Finger PIP Flexion
Periodo de tiempo: 1 day

The measurement device will be placed on a flat surface. The patient will be instructed to perform flexion of the proximal interphalangeal (PIP) joint of the second finger and press the fingertip against the measurement pad with maximum force. Second finger pıp flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Second Finger DIP Flexion Muscle Strength
Periodo de tiempo: 1 day

The measurement device will be placed on a flat surface. The patient will be instructed to perform flexion of the distal interphalangeal (DIP) joint of the second finger while the metacarpophalangeal (MCP) and distal interphalangeal (DIP) joints are stabilized and press the fingertip against the measurement pad with maximum force. Second Finger DIP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Third Finger PIP Flexion Muscle Strength
Periodo de tiempo: 1 day

The measurement device will be placed on a flat surface. The patient will be instructed to perform flexion of the proximal interphalangeal (PIP) joint of the third finger and press the fingertip against the measurement pad with maximum force. Third Finger PIP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Third Finger DIP Flexion muscle strength
Periodo de tiempo: 1 day

The third finger will be positioned with the MCP and PIP joints stabilized. The measurement pad will be positioned against the palmar aspect of the distal phalanx. The patient will be instructed to perform maximal flexion of the DIP joint against the pad.

1 day

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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Publicaciones Generales

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 (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

1 de enero de 2027

Finalización del estudio (Estimado)

1 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

9 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Publicado por primera vez (Actual)

29 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de septiembre de 2026

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

28 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

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INDECISO

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. .

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