- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07788287
Transfer of Energy Capacitive and Resistive Therapy on Shoulder Range of Motion In Idiopathic Adhesive Capsulitis
Effect of Transfer of Energy Capacitive and Resistive (TECAR) Therapy on Shoulder Range of Motion In Idiopathic Adhesive Capsulitis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Adhesive capsulitis or frozen shoulder is often defined as insidious shoulder pain and range of motion (ROM) loss of more than 25% in at least 2 planes. Furthermore, there was passive external rotation loss of more than 50% of the unaffected shoulder, or less than 30° of available external rotation. The specific cause of the rotator interval contracting and the capsule thickening, which results in shoulder pain and a decrease in capsular volume, is still a mystery One of the alternate methods used for the treatment of musculoskeletal diseases is transfer energy capacitive and resistive or TECAR therapy, which is a deep heat-generating modality delivering radiofrequency energy ranging from 300 kHz to 1 MHz. TECAR therapy enhances the physiological tissue metabolism by transferring energy and increasing electrolytic motions within tissues, causing increased deep temperature, microcirculation, vasodilatation, and muscle flexibility Considering the importance of proper adhesive capsulitis treatment and the lack of rigorous studies, especially randomized controlled studies, on the effects of TECAR Therapy in adhesive capsulitis management and capsular extensibility.
Besides, application of TECAR therapy may show added benefit, like decreasing the time needed to gain ROM when compared to stretching only and pain and function. Results could provide more insight into the directional preference of modalities during treatment. Therefore, the results of the current study might help to improve practice, helping clinicians to consider using TECAR therapy as an effective treatment for primary frozen.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohamed H Nasser, Master
- Número de teléfono: 01007966818
- Correo electrónico: Mohamed.hemiednasser@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Nesrin F Mahmoud, PHD
- Número de teléfono: 01127283925
- Correo electrónico: Dr-nesreenfawzy@cu.edu.eg
Ubicaciones de estudio
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Cairo, Egipto
- Cairo University
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Contacto:
- Mohamed H Nasser, Master
- Número de teléfono: 01007966818
- Correo electrónico: Mohamed.hemiednasser@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients of both genders with primary adhesive capsulitis.
- Patients aged between 40-65.
- Pain duration of three months or more.
- Range of motion loss of greater than 25% in at least 2 planes and passive external rotation loss that is greater than 50% of the uninvolved shoulder or less than 30° of external rotation.
Exclusion Criteria:
- Bilateral adhesive capsulitis,
- Systemic diseases such as rheumatoid arthritis,
- Malignancies,
- Heart diseases
- Infections
- Coagulation disorders
- Full rotator cuff tear
- History of recent shoulder surgery
- Neurological problems involving the upper extremity
- Shoulder joint osteoarthritis
- Upper extremity fractures
- Cervical radiculopathy
- Impaired sensation
- Having a heart pacemaker
- Pregnancy
- Physiotherapy treatment in the previous 6 weeks
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: Transfer of Energy Capacitive and Resistive (TECAR) Therapy and stretching exercise group
The participants will receive transfer of energy capacitive and resistive (TECAR) therapy with stretching for limited ROM (Flexion, abduction, internal rotation, and external rotation).
Patients will receive three sessions per week for 1 month.
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To apply TECAR therapy, the patient will lie supine, with the passive electrode, a flexible rectangular stainless steel plate measuring 150 £ 200 mm, placed under the affected side's scapula.
A rigid circular metallic electrode with a 60-mm diameter will be used as the active electrode.
Using the resistive mode with the power of 8 to 10 mA, the active electrode will be circularly moved continuously for 10 minutes on the anterior-inferior shoulder capsule while the patient's arm will be held at the end existing range of abduction and external rotation.
As well, a conductive cream will be used as a coupling medium between the electrodes and the skin.
Based on the manufacturer's recommendation for safe performance, the TECAR intensity will be set as the most effective method, causing no pain based on each patient's feedback.
While the patients were lying on the bed, they would receive cyclic (intermittent) stretching.
Cyclic stretching is the application, release, and reapplication of a relatively short-duration stretch force repeatedly but progressively.
Twenty seconds of stretching and 10 seconds of rest will be used 10 times in each of the following directions (flexion, scapular plane abduction, external rotation, and internal rotation) and stretch to target rotator cuff interval.
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Comparador activo: Stretching exercise group
The participants will receive stretching alone for limited ROM (Flexion, abduction, internal rotation and external rotation).
Patients will receive three sessions per week for 1 month.
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While the patients were lying on the bed, they would receive cyclic (intermittent) stretching.
Cyclic stretching is the application, release, and reapplication of a relatively short-duration stretch force repeatedly but progressively.
Twenty seconds of stretching and 10 seconds of rest will be used 10 times in each of the following directions (flexion, scapular plane abduction, external rotation, and internal rotation) and stretch to target rotator cuff interval.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Glenohumeral External Rotation range of motion (ROM) in Adducted shoulder
Periodo de tiempo: 1 month
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To measure external rotation range of motion (ROM) with the shoulder adducted, the patient will be positioned in supine with the upper arm positioned at the side and the elbow flexed to 90°.
The examiner will passively externally rotate the glenohumeral joint until end range is reached.
Range of motion will be measured by placing the axis of the goniometer on the olecranon process.
The stationary arm will be aligned with the vertical position.
The movable arm will be aligned with the ulnar styloid process.
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1 month
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Glenohumeral External Rotation range of motion (ROM) in Abducted shoulder
Periodo de tiempo: 1 month
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External rotation range of motion (ROM) may also be measured with the shoulder abducted to 45° or to 90° in the frontal plane (if the patient has the available abduction ROM).
The stationary arm of goniometer will be aligned with the vertical position.
The movable arm will be aligned with the ulnar styloid process.
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1 month
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Glenohumeral Internal Rotation range of motion (ROM) in Abducted shoulder
Periodo de tiempo: 1 month
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Internal rotation range of motion (ROM) will be measured while the patient is positioned in supine, the shoulder abducted to 90°, and the elbow flexed to 90°.
If glenohumeral abduction is less than 90°, a 45° abduction angle can be used.
The examiner passively internally rotates the glenohumeral joint until end range is reached, ensuring that there is no scapular compensation.
Range of motion will be measured by placing the axis of the goniometer on the olecranon process.
The stationary arm will be aligned with the vertical position.
The movable arm will be aligned with the ulnar styloid process
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1 month
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Shoulder Flexion range of motion (ROM)
Periodo de tiempo: 1 month
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To measure flexion range of motion (ROM), the patient will be positioned in supine with the arm rest at the side.
The examiner will passively flex the shoulder until end range is reached (with no compensatory movements from the thorax and the lumbar spine).
Range of motion will be measured by placing the axis of the goniometer on the greater tuberosity.
The stationary arm will be aligned with the midline of the trunk.
The movable arm will be aligned with the lateral epicondyle.
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1 month
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Shoulder Abduction range of motion (ROM)
Periodo de tiempo: 1 month
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To measure abduction range of motion (ROM), the patient will be positioned in supine with the arm comfortably by the side.
The examiner passively abducts the shoulder until end range is reached (shoulder must remain in the same plane).
Range of motion will be measured by placing the axis of the goniometer on the head of the humerus.
The stationary arm will be aligned parallel with the midline of the sternum.
The movable arm will be aligned with the midshaft of the humerus.
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1 month
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Shoulder extension range of motion (ROM)
Periodo de tiempo: 1 month
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To measure extension range of motion (ROM), the patient is positioned in prone position with the arm rest at the side.
The examiner passively extends the shoulder until the end range is reached.
Range of motion will be measured by placing the axis of the goniometer on the greater tuberosity.
The stationary arm will be aligned with the midline of the trunk.
The movable arm will be aligned with the lateral epicondyle.
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1 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Assessment of shoulder pain
Periodo de tiempo: 1 month
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The Arabic version of the shoulder pain and disability index (SPADI) will be used.
The 13-item SPADI consists of two primary components, five pain items, and eight disability items.
The five pain items will be recorded to determine pain level.
The weighting of each domain score for the overall score is equal.
The total score for pain is 50.
The overall score is between 0 and 100, with 0 denoting no pain or difficulty.
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1 month
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Assessment of shoulder function
Periodo de tiempo: 1 month
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The Arabic version of the shoulder pain and disability index (SPADI) will be used.
The 13-item SPADI consists of two primary components, five pain items, and eight disability items.
The eight disability items will be recorded to determine shoulder function.
The weighting of each domain score for the overall score is equal.
The total score for the disability scale is 80.
A percentage is used to represent the overall SPADI score.
The overall score is between 0 and 100 ; 0 for best and 100 for worst.
More disability is indicated by a higher score.
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1 month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Mohamed A Mohamed, As.professor, Cairo University
- Silla de estudio: Mona M Ibrahim, As.Professor, Cairo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
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
Última actualización publicada (Actual)
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
- Enfermedades musculoesqueléticas
- Enfermedades Articulares
- Bursitis
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Ejercicio
- Terapéutica
- Ejercicios de estiramiento muscular
Otros números de identificación del estudio
- P.T.REC/012/006279
Información sobre medicamentos y dispositivos, documentos del estudio
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