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Impact of Neuromuscular Control With and Without Electrical Stimulation and Long-term Effect of Kinetic Chain Exercises in Multidirectional Shoulder Instability Patients

20 de mayo de 2026 actualizado por: National Taiwan University Hospital

Background: Shoulder instability is commonly observed in adolescents and young females, ranging from asymptomatic multidirectional instability (MDI) to symptomatic conditions. Patients with MDI often experience shoulder pain, muscle tension, and episodes of subluxation. This condition is associated with hypermobility spectrum disorder (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS), both characterized by generalized joint laxity and recurrent joint dislocations, significantly affecting daily activities and athletic performance. Current literature lacks clarity on the actual humeral head displacement, shoulder joint kinetics, and muscle activity characteristics during movement in patients with MDI accompanied by HSD or hEDS. Additionally, the effects of electrical stimulation on different shoulder muscles and its impact on humeral head displacement in MDI patients remain to be validated.

Objective: The purposes of this study are to (1) examine whether patients with hEDS/HSD and MDI have increased humeral head translation compared to healthy controls during three isometric contraction ; (2) investigate the relationship between humeral head translation and associated muscle activity during three isometric exercises ; (3) examine the effect of NMES and NMCT to humerus/scapula muscles on humeral head translations in MDI patients with hEDS/HSD Outcome measurements: The primary outcomes include changes in acromiohumeral distance (AHD) or humeroglenoid distance (HGD) under four conditions (no stimulation, NMCT, BLH/Infraspinatus/MD stimulation, and SA stimulation) during three isometric contractions (shoulder flexion, horizontal adduction, and fully extended elbow holding weight).

The secondary outcomes assess muscle activation differences in BLH, infraspinatus, MD, UT, LT, and SA before and after NMCT.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

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.

Estudio Contacto

  • Nombre: Jiu Jenq Lin
  • Número de teléfono: 886233668126
  • Correo electrónico: jiujlin@ntu.edu.tw

Ubicaciones de estudio

      • Taipei, Taiwán, 100
        • Reclutamiento
        • School and graduate institution of physical therapy
        • 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

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Age: Between 20 and 50 years old.

Patients with Multidirectional Shoulder Instability Must Meet the Following Conditions:

(A) Generalized Joint Hypermobility: Beighton score ≥ 4/9. (B) Shoulder Laxity Verified in at Least Two Directions During Clinical Examination (must meet A and B, or A and C): Inferior: Presence of a sulcus sign under the acromion or a positive Gagey hyperabduction test.

Anterior: Positive anterior load and shift test or active shoulder external rotation > 85 degrees or passive shoulder external rotation > 90 degrees.

Posterior: Positive posterior load and shift test or positive posterior jerk test.

(C) Shoulder Pain for at Least Three Months Before the Start of the Study. (D) Signs of Shoulder Instability in Daily Life Without a Traumatic Cause. (E) Ability to Raise the Arm Above 120 Degrees Without Experiencing Subluxation or Dislocation of the Shoulder.

Exclusion Criteria:

  • Shoulder pain caused by trauma. History of shoulder fractures or dislocations. Cervical radiculopathy. Degenerative joint disease of the shoulder. Previous shoulder surgery. Frozen shoulder. Pain score greater than 5 during experimental movements. Redness, swelling, or open wounds on the skin within the experimental area. Sensory abnormalities. Cognitive impairment.

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: multidirectional instability with HSD
The GM300TE COMBO NMES (Gemore Technology Co., Ltd., New Taipei City, Taiwan), a portable machine with dual controllable channels and a manual switch, will be applied to the biceps long head, infraspinatus, middle deltoid, LT and SA. Muscle force generation is modulated by stimulated frequency, pulse width, and intensity [Bdaiwi et al., 2015]. It linearly increases with stimulated amplitude and pulse duration. The electronics of the unit creates the electrical impulses with an output frequency of 50 Hz and a pulse width of 300 microseconds. The synchronous (S) mode and asymmetrical rectangular wave-pulse will be used throughout the experiment following protocol from previous research (Bdaiwi, et al., 2015). The amplitude will be settled as muscle motor-level contraction with self-perception of maximal tolerable intensity. The time of tetanic stimulation is 7 seconds with 20-second intervals between stimulations to avoid muscle fatigue. The two circular electrodes are used on each muscl
To ensure that the humeral head remains centered during the three specific isometric tasks, the examiner positioned the shoulder according to the direction of instability (anterior, inferior, or posterior) by placing the arm in 20° of shoulder flexion, 0° (neutral), or 10° of extension, respectively. In each position, the examiner gently applied a downward force on the upper arm in a horizontal direction, and the participant was instructed to gently resist the force. The goal was to guide the humeral head gradually toward the center of the glenoid, without excessive scapular movement. This training was directly supervised by a physical therapist, who provided verbal and tactile feedback to ensure correct movement execution (Figure 1). The physical therapist was also responsible for conducting the USG assessment. After a 5-minute familiarization session, participants performed the designated instability-specific isometric task for 3 repetitions.
Comparador activo: patients with multidirectional instability
The GM300TE COMBO NMES (Gemore Technology Co., Ltd., New Taipei City, Taiwan), a portable machine with dual controllable channels and a manual switch, will be applied to the biceps long head, infraspinatus, middle deltoid, LT and SA. Muscle force generation is modulated by stimulated frequency, pulse width, and intensity [Bdaiwi et al., 2015]. It linearly increases with stimulated amplitude and pulse duration. The electronics of the unit creates the electrical impulses with an output frequency of 50 Hz and a pulse width of 300 microseconds. The synchronous (S) mode and asymmetrical rectangular wave-pulse will be used throughout the experiment following protocol from previous research (Bdaiwi, et al., 2015). The amplitude will be settled as muscle motor-level contraction with self-perception of maximal tolerable intensity. The time of tetanic stimulation is 7 seconds with 20-second intervals between stimulations to avoid muscle fatigue. The two circular electrodes are used on each muscl
To ensure that the humeral head remains centered during the three specific isometric tasks, the examiner positioned the shoulder according to the direction of instability (anterior, inferior, or posterior) by placing the arm in 20° of shoulder flexion, 0° (neutral), or 10° of extension, respectively. In each position, the examiner gently applied a downward force on the upper arm in a horizontal direction, and the participant was instructed to gently resist the force. The goal was to guide the humeral head gradually toward the center of the glenoid, without excessive scapular movement. This training was directly supervised by a physical therapist, who provided verbal and tactile feedback to ensure correct movement execution (Figure 1). The physical therapist was also responsible for conducting the USG assessment. After a 5-minute familiarization session, participants performed the designated instability-specific isometric task for 3 repetitions.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Western Ontario Shoulder Index (WOSI)
Periodo de tiempo: At baseline, week 4, and week 8 after the intervention
The Western Ontario Shoulder Instability Index (WOSI) is a patient-reported questionnaire used to evaluate shoulder-related quality of life in individuals with shoulder instability. The questionnaire includes items related to physical symptoms, sports and work function, lifestyle, and emotional well-being. Total scores range from 0 to 2100, with higher scores indicating greater impairment and poorer shoulder function.
At baseline, week 4, and week 8 after the intervention

Colaboradores e Investigadores

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

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)

9 de noviembre de 2025

Finalización primaria (Estimado)

15 de junio de 2026

Finalización del estudio (Estimado)

30 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

3 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2026

Publicado por primera vez (Actual)

28 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de mayo de 2026

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

20 de mayo de 2026

Última verificación

1 de marzo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 202501014RINA

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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