- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03635242
Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Healed Patients
Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Post-treatment Healed Patients by Therapeutic Exercise
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The records are made simultaneously with the different evaluation equipment, accelerometer and pressure platform. The tests are performed in a control group of healthy subjects, and in an experimental group with DLC receiving a program of therapeutic exercise based and pain education based on neuroscience.
After the collection of the records, the behavior patterns in both groups are evaluated, the possible differences among them are established for the clinimetric indicators analyzed related to the postural control, as well as a characteristic of the sample.
Subsequently, through the evaluation after the intervention of the experimental group we will analyze the effect of a physiotherapy treatment based on the therapeutic exercise of motor control on parameters related to postural control and clinical variables (perceived pain, mechanosensitivity, disability and proprioceptive repositioning of the lumbar spine )
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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Badajoz, España, 06071
- Universidad de Extremadura
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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:
- low back pain with painful perception on a daily or almost daily basis for more than three months of clinical course, with or without pain radiating to the lower extremities above the knee.
- not having metal implants in the spine
- own ability to read and write
- and access the study voluntarily.
Exclusion Criteria:
- vestibular disorders
- without severe visual impairment
- no medication intake with a potential effect on balance during the 90 days prior to data collection
- physiotherapy treatment 2 weeks before the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Control. no therapeutic program
The control group continued to perform their daily activities without changing any habit.
Group of healthy subjects Assessment of postural control through accelerometry and pressure platform
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The control group continued to perform their daily activities without changing any habit.
Group of healthy subjects Assessment of postural control through accelerometry and pressure platform
|
Experimental: Experimental. Therapeutic program
People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months. Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform |
People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months. Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
pressure platform and accelerometry
Periodo de tiempo: 4 weeks
|
Stay for 30 seconds each test on a pressure platform.
Accelerometer in the pelvis (center of mass), fixed by velcro tape.
Application of the Romberg test.
(Standing with open eyes and closed on stable and unstable surface).The unit of the accelerometer is mg (1 mg = 0.001) and the kinetic energy of the signal is measured in Julians x 10-6 The displacement unit of the pressure center of the platform is millimeters
|
4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
weight
Periodo de tiempo: 4 weeks
|
Descriptive variable.
Its unit of measurement is Kilograms
|
4 weeks
|
Height
Periodo de tiempo: 4 weeks
|
Descriptive variable.
Its unit of measurement is meters
|
4 weeks
|
age
Periodo de tiempo: 4 weeks
|
Descriptive variable.
Its unit of measurement is years
|
4 weeks
|
EVA (Visual Analog Scale).
Periodo de tiempo: 4 weeks
|
Used for pain assessment in an analogical way, that is, by means of a line of 10 centimeters.
0 (absence of pain); 10 (maximum pain)
|
4 weeks
|
Algometry
Periodo de tiempo: 4 weeks
|
Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral)
|
4 weeks
|
Joint Position Sense (JPS)
Periodo de tiempo: 4 weeks
|
Joint Position Sense (JPS) to evaluate the proprioceptive joint positioning of the lumbar spine with a digital goniometer at 30º flexion in standing and sitting
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4 weeks
|
Roland Morris
Periodo de tiempo: 4 weeks
|
determine the degree of disability.
The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)
|
4 weeks
|
Oswestry Disability Index
Periodo de tiempo: 4 weeks
|
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability Scoring instructions For each section of the total possible score is 5: if the first statement is mark ed the section score = 0; if the last statement is marked, it = 5. |
4 weeks
|
Pain Catastrophizing Scale (PCS)
Periodo de tiempo: 4 weeks
|
it measures the catastrophic thoughts before the pain, that is, the negative thought before the pain. In the PCS, people take the painful past experience as a reference and indicate the degree to which they experience certain thoughts and feelings. The PCS is composed of 13 items, on a Likert scale of 5 points that goes from 0 (never) to 4 (always). Higher scores indicate higher levels of catastrophism |
4 weeks
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The Tampa Kinesiofobia Scale (TSK)
Periodo de tiempo: 4 weeks
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It is commonly used in clinical practice to quantify pain levels related to fear of activity or to a new injury in patients with back pain.
Patients with high levels of kinesiofobia are often considered at greater risk of developing long-term activity limitation and chronicity
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4 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Mª Dolores MD Apolo-Arenas, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
- Director de estudio: Luis LE Espejo-Antúnez, PhD, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
- Investigador principal: Alejandro Caña-Pino, PT,MSc, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 08062018
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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