- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04789265
Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain
Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain: a Randomized Controlled Trial
In this study, it was planned to investigate the effectiveness of instrument-assisted soft tissue mobilisation (IASTM) in patients with chronic neck pain. Forty eight individuals with chronic neck pain between the ages of 18-70 were included in the study. Individuals were randomly divided into two groups as Combined Therapy (CT) (n = 24) and Exercise Therapy (ET) (n = 24) groups. All exercises were applied to the participants for 4 weeks, 3 times a week, by an experienced physiotherapist for 5 years under supervision. ET which included stretching and strengthening exercises involving the neck, shoulder and around the scapula muscles applied according to the tolerance of the individuals and targeted to be most beneficial in daily life activities.
CT in addition to the ET applied 3 times a week for 4 weeks, the participants received a total of 8 sessions of IASTM on the days they came to the treatment twice a week, before the ET. As soon as the participants came to the session, IASTM was applied first. Following the IASTM application, ET was applied in the same protocol and under the same therapist supervise with the ET group.
Before and after treatment, deep neck flexor muscle endurance (DNFME), pain severity with Visual Analogue Scale (VAS) and Brief Pain Inventory (BPI), functional status with Neck Disability Index (NDI), quality of life with Nottingham Health Profile (NHP) treatment and treatment satisfaction was evaluated.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beykoz
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Istanbul, Beykoz, Pavo, 5557694774
- Aysegul Bostan
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Istanbul, Beykoz, Pavo
- Aysegul Bostan
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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, Exclusion Criteria:
Individuals aged 18-70 years with neck pain due to a nonspecific disorder for at least 3 months were included.
Individuals with history of cancer (within the last five years), pregnancy, serious skin disorders, previous neck surgery, disc prolapse, spondylolisthesis, vertebral fractures, spinal stenosis, arthritis, osteoporosis, recent neck trauma (within the last 48 hours), severe night pain, symptoms of infection, psychological disorder, and those who received therapy for neck pain in the last 6 months were not included.
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: Combined Therapy (Instrumented Soft Tissue Mobilization)
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IASTM is a new, non-invasive, conservative therapeutic approach.
Instead of the therapist's hands and fingers in treatment, these devices are used to provide contact mobilization power.
AYDM intervention, such as friction, rubbing massage treatments, requires the therapist to apply a significant amount of pressure.
The main purpose of IASTM is to eliminate scar tissue and to restore the normal function of the tissue following soft tissue regeneration.
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Sin intervención: Control Group (Exercise Therapy)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Neck Flexor Muscle Endurance
Periodo de tiempo: baseline to 4 weeks after
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Neck flexor endurance of the participants were evaluated with a stopwatch for holding their neck in lying position.
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baseline to 4 weeks after
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Nottingham Health Profile
Periodo de tiempo: baseline to 4 weeks after
|
NSP is a general health status questionnaire that measures the physical, emotional and social conditions of individuals.
The questionnaire consists of 38 items and 6 sub-sections: physical mobility (8 items), pain (8 items), sleep (5 items), emotional reactions (9 items), social isolation (5 items) and energy level (3 items).
consists of.
Each item is answered as "yes" or "no".
The score that can be obtained from each section varies between 0 and 100.
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baseline to 4 weeks after
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Neck Disability İndex
Periodo de tiempo: baseline to 4 weeks after
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The index, which evaluates subjective symptoms and activities of daily living, consists of 10 parts (pain intensity, personal care, lifting, reading, headache, concentration, work life, driving, sleep and leisure activities).
There are 6 options ranging from 0 to 5 points for each section.
The total score ranges from 0 to 50 (0: no apology; 50: maximum disability), with a higher total score indicating an increased disability.
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baseline to 4 weeks after
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Visual Analog Scale
Periodo de tiempo: baseline to 4 weeks after
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This scale consists of a 10 cm linear line.
The starting point of the line is 0, no pain; the last point, 10, the most severe pain encountered in life; 5 means a moderate pain.
The subjects were asked to rate the severity of their pain numerically on the scale.
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baseline to 4 weeks after
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Colaboradores e Investigadores
Patrocinador
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
- 10376522
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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