- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07785427
Effect of Mechanically Loaded Neuro-dynamics in Subjects With Thoracic Outlet Syndrome
Effect of Mechanically Loaded Neuro-dynamics on Physiological Findings and Functional Outcomes in Subjects With Thoracic Outlet Syndrome
the study was done to: To assess the effect of Mechanically Loaded Neuro-dynamics on pain reduction in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on shoulder range of motion in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on clinical provocative tests in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on neurophysiological findings in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on quality of life and psychological status in subjects with thoracic outlet syndrome.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohammed Abdulmohsen Almohamadi, physical therapist
- Número de teléfono: 01050366830
- Correo electrónico: ptmohammed1993@gmail.com
Ubicaciones de estudio
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Kafr ash Shaykh, Egipto
- out-patient clinic, faculty of physical therapy - Kafrelsheikh University.
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Contacto:
- Mohammed Abdulmohsen Almohamadi, physical therapist
- Número de teléfono: 01050366830
- Correo electrónico: ptmohammed1993@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Subjects from both genders diagnosed with Thoracic Outlet Syndrome will be recruited through direct referrals from their neurosurgeon.
- Subjects age between 30.8±7.4 years
- Subjects body mass index = 19.5±2.8
- Control group includes health volunteer subjects with negative root test results under supervision of neurosurgeon.
Exclusion Criteria:
The exclusion criteria are:
- head injury, stroke.
- epilepsy episodes.
- mental disorders.
- cardiovascular disease.
- having a pacemaker or cochlear implant.
- pregnancy, oncological episodes, inflammatory disease, myelopathy, degenerative changes in the cervical spine (after verification on computed tomography or magnetic resonance imaging scans).
- peripheral neuropathies from the level of the arm and COVID-19-related symptoms
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Mechanically Loaded Neuro-dynamics
involved 18 participants and received physical therapy management will include 11 visits over 11 weeks, Mechanically Loaded Neuro-dynamics was implemented using green medium-resistance bands (approximately 4.6-6.9
lbs. at 100% elongation).
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Physical therapy management will include 11 visits over 11 weeks, utilizing green medium-resistance bands (4.6-6.9 pounds at 100% elongation).
The protocol involves: weeks 3-4 with low tension isometric holds (5-10 seconds) in partial range; weeks 5-7 with dynamic repetitions (10-15 repetitions, 3 sets) in full range; and weeks 8-11 featuring sport-specific load progression with cycling postures and upper extremity tasks.
Repetitions will be slow and controlled, with cues to minimize guarding or Valsalva.
Progression will depend on symptom response and visual analogue scale scores, with Mechanically Loaded Neuro-dynamics performed 1-2 times weekly in-clinic and daily home exercises.
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Comparador activo: traditional physical therapy program
involved 18 participants and received a traditional physical therapy program for Thoracic Outlet Syndrome (TOS)
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traditional physical therapy program
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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assessment of Active and passive Range of motion
Periodo de tiempo: At baseline and after 11 weeks
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Cervical spine range of motion (ROM) was assessed using a goniometer.
Participants were positioned comfortably in a standardized sitting position, with the trunk stabilized to minimize compensatory movements.
Cervical flexion, extension, lateral flexion, and rotation were measured in degrees.
The goniometer was aligned according to standard anatomical landmarks for each movement, and the active ROM was recorded at the end of the available pain-free range.
Measurements were performed consistently for all participants under the same testing conditions.
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At baseline and after 11 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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assessment of sensory nerve conduction velocity
Periodo de tiempo: At baseline and after 11 weeks
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For the digital sensory nerve conduction study, we will use standard antidromic techniques with a fixed distance of 11 cm between the recording and stimulating electrodes for the ulnar and 13 cm for the median sensory nerves.
Standard techniques and distances between recording and stimulating electrodes will be used for the medial antebrachial cutaneous (12 cm), lateral antebrachial cutaneous (12 cm), and the dorsal ulnar cutaneous (8 cm) nerve conduction study.
Sensory nerve conduction study parameters included sensory nerve action potential, amplitude and peak latency
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At baseline and after 11 weeks
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assessment of motor nerve conduction velocity
Periodo de tiempo: At baseline and after 11 weeks
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For motor nerve conduction study, also will be used a fixed distance of 7 cm between the recording and stimulating electrodes for both median and ulnar nerves.
motor nerve conduction study parameters included compound muscle action potential amplitude, area, distal latency, duration of the negative phase, and forearm conduction velocity.
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At baseline and after 11 weeks
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assessment of physical function and symptoms of the upper limb
Periodo de tiempo: At baseline and after 11 weeks
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The Disabilities of the Arm, Shoulder and Hand is a 30-item instrument assessing health status in daily activities, symptoms, social functioning, and psychological factors over the past week.
Responses range from 1 (no difficulty) to 5 (unable to perform), yielding scores from 0 to 100, where higher scores indicate greater disability.
The he Disabilities of the Arm, Shoulder and Hand demonstrates strong reliability, with an intraclass correlation coefficient of 0.74-0.95.
The minimum detectable change is 11 points, while the minimum clinically important difference is 10.83 points, indicating significant changes in patient function.
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At baseline and after 11 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Mohammed_Msc
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.
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