- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03416556
Manual Therapy in Chronic Shoulder Pain Treatment
The Initial Effects on Pain, Pain Sensitivity, Range of Motion and Muscle Strength of an Anteroposterior Mobilization of the Glenohumeral Joint in Overhead Athletes With Chronic Shoulder Pain
Background: Passive oscillatory mobilizations are often employed by physiotherapists to reduce shoulder pain and increase function. However, there is little data about the neurophysiological effects of these mobilizations.
Objectives: To investigate the initial effects of an anteroposterior (AP) shoulder joint mobilization on measures of pain and function in overhead athletes with chronic shoulder pain.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Madrid
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Alcala de Henares, Madrid, España, 2805
- Clinical University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- History of chronic shoulder pain lasting ≥3 months.
- Play overhead sport regularly.
Exclusion Criteria:
- Had a non-musculoskeletal origin of shoulder pain.
- Previous surgery to the shoulder complex.
- Frozen shoulder.
- Any co-existing inflammatory, infectious or neurological condition.
- The patient from physiotherapy treatment.
- Any evidence of pain referred from the cervical spine to the shoulder
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Mobilization to the glenohumeral joint
This condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder
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The treatment condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder.
In particular, a Grade III AP glide to the humeral head with the arm positioned in 90º of glenohumeral abduction and full internal rotation was used.
The posterior gliding force to the humeral head was applied maintaining the glide at right angles to the plane of movement and at a frequency of 2 Hz which was controlled by means of a metronome.
The arm was returned to its original position between each set.
Otros nombres:
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Comparador falso: The manual contact condition
In this condition the therapist positioned the patient in a mid-range position of glenohumeral abduction and internal rotation and applied the hands to the same contact point as in the treatment condition.
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During the manual contact condition the therapist positioned the patient in a mid-range position of glenohumeral abduction and internal rotation and applied the hands to the same contact point as in the treatment condition.
However, a simulated posterior glide was performed but with minimal pressure actually applied.
The number of repetitions and sets were as per the treatment condition.
During the no-contact condition, the subject remained in the initial starting position thorough the entire session but there was no manual contact between the therapist and the participant.
The total treatment time was the same as per the other conditions.
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Sin intervención: No-contact condition
There was no manual contact between the therapist and the participant
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-reported shoulder pain
Periodo de tiempo: Change from Baseline at 5 minutes after intervention
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Participants were asked to indicate the intensity of their current shoulder pain using a numeric rating pain scale (NRPS).
In this scale, 0 is not pain and 10 is the worse pain possible
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Change from Baseline at 5 minutes after intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Shoulder disability
Periodo de tiempo: Change from Baseline at 24 hours after treatment
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The DASH is comprised of 30 items (disability/symptom section) and two optional sections related to the impact of pathology on work and sports.
Each item is scored from 1 to 5 with increasing values representing more severity of symptoms.
The total score for the disability/symptoms section ranges from 30 to 150, but it is then transformed to a scale from 0 (better score possible) to 100 (worse score possible).
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Change from Baseline at 24 hours after treatment
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Shoulder range of movement (ROM)
Periodo de tiempo: Change from Baseline at and 5 minutes after treatment
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Active elevation in the scapular plane and passive glenohumeral internal and external rotation were measured using a Standard BASELINE ® 12-inch plastic goniometer following previous guidelines.
The 0 degrees of movement is worse and 180 degrees is the better
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Change from Baseline at and 5 minutes after treatment
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Shoulder muscles strength
Periodo de tiempo: Change from Baseline at 5 minutes after treatment
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Isometric strength of the shoulder internal and external rotator musculature was measured using a portable hand-held dynamometer (Nicholas Manual Muscle Tester, Lafayette Instruments, USA).
Normal external rotation strength is 20 Newtons and 27 newton in internal rotation strength
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Change from Baseline at 5 minutes after treatment
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Pressure pain threshold (PPT)
Periodo de tiempo: Change from Baseline at 5 minutes after treatment
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The PPT was measured using an analogue Fisher algometer (Force Dial model FDK, Wagner Instruments) with a surface area at the round tip of 1cm2.
The algometer probe tip was applied perpendicular to the skin at a rate of 1kg/cm2/s until the first onset of pain.
The PPT value is specific in each subject.The minimal clinically important difference is 2Kg/cm
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Change from Baseline at 5 minutes after treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Daniel Pecos-Martin, Dr, Alcala University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- H1496053548524
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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