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Investigation The Efficacy of Manual Therapy and Exercise in Patients With Glenohumeral Arthritis

30 de diciembre de 2019 actualizado por: Sibel Gayretli Atan, Istanbul University

Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation

The aim of the investigator's study is to compare the efficacy of manual therapy and exercise practices compared to exercise practice in patients with Glenohumeral Arthritis. Thirty volunteer patients will include into the study.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Patients will randomly divide into two groups. A common exercise program was applied to both groups during 15 sessions. Manual therapy techniques will apply to the manual therapy group in addition to exercise practices. Patients will evaluate in terms of functional status, pain, range of motion, muscle strength and health-related quality before and after 5 weeks of treatment. Also, patient's satisfaction from treatment will evaluate at the 5th week of the treatment. DASH and ASES forms for functional status, VAS for pain, digital goniometer for range of motion, manual muscle test for muscle strength, SF-12 for health-related quality of life, and Global Rating of Change (GRC) Scale for patient satisfaction will be used as evaluation criteria.

Tipo de estudio

Intervencionista

Inscripción (Actual)

30

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.

Ubicaciones de estudio

  • Pavo
    • Istanbul
      • Bakırköy, Istanbul, Pavo, 34180
        • Istanbul University

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

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 40 years and older patients
  • To be diagnosed with GHOA by specialist physician via MRI, US or radiography and physical examination
  • Unilateral shoulder pain lasting more than 2 months seen during daily living activities and at rest

Exclusion Criteria:

Patients with:

  • Severe arthrosis
  • Tumor
  • Cervical radiculopathy
  • Emotional or cognitive problems
  • A neurological disease that causes muscle weakness on the shoulder
  • A skin disease that may affect upper extremity assessment.
  • Frozen shoulder
  • Thoracic outlet 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

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: ''Manuel Therapy group''
This treatment group will be received Manuel Therapy techniques and exercise interventions.
Otro: Manuel Therapy plus Exercise Intervention
Shoulder mobilization techniques include glenohumeral traction, anterior, posterior and inferior glide. We will also use anterior, posterior and inferior joint stretching exercises and scapular mobilization. Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.
Experimental: ''Exercise group''
This treatment group will be received only exercise interventions.
Otro: Exercise Intervention
Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Shoulder Range of Motion (ROM)
Periodo de tiempo: Evaluation will be performed first time at baseline and second time will be performed after 5 weeks rehabilitation program. After treatment "change" will be assessed.
The shoulder flexion, abduction, internal and external rotation ROM will be evaluated with digital goniometer while the patient will be in supine position.
Evaluation will be performed first time at baseline and second time will be performed after 5 weeks rehabilitation program. After treatment "change" will be assessed.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
Periodo de tiempo: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections. The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Visual Analogue Scale (VAS)
Periodo de tiempo: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
The levels of pain is felted at rest / activity / night will be measured using Visual Analogue Scale (VAS).Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Manual Muscle Test
Periodo de tiempo: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Manual Muscle Test is a procedure for the evaluation of strength of individual muscle or muscles group, based upon the effective performance of a movement in relation to the forces of gravity or manual resistance through the available ROM.
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Short Form 12 (SF-12)
Periodo de tiempo: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
SF-12 will be used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Global Rating of Change (GRC) Scale
Periodo de tiempo: Evaluation will be performed after 5 weeks rehabilitation program.
Global Rating of Change (GRC) scale will be used to assess the overall satisfaction levels of the patients. Patients will be asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
Evaluation will be performed after 5 weeks rehabilitation program.
The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Periodo de tiempo: Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment.
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

Colaboradores e Investigadores

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

Patrocinador

Istanbul University

Investigadores

  • Investigador principal: Sibel Gayretli Atan, sssibel_38@hotmail.com

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)

20 de mayo de 2019

Finalización primaria (Actual)

29 de noviembre de 2019

Finalización del estudio (Actual)

30 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

11 de abril de 2019

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2019

Publicado por primera vez (Actual)

21 de mayo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de enero de 2020

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

30 de diciembre de 2019

Última verificación

1 de noviembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ''IU''

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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