Impact of Neuromuscular Control With and Without Electrical Stimulation and Long-term Effect of Kinetic Chain Exercises in Multidirectional Shoulder Instability Patients
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jiu Jenq Lin
- Número de telefone: 886233668126
- E-mail: jiujlin@ntu.edu.tw
Locais de estudo
-
-
-
Taipei, Taiwan, 100
- Recrutamento
- School and graduate institution of physical therapy
-
Contato:
- Jiu Jenq Lin
- Número de telefone: 886233668126
- E-mail: jiujlin@ntu.edu.tw
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Western Ontario Shoulder Index (WOSI)
Prazo: 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
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 202501014RINA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .