Effects of Magnetic Tape Over Hip Flexion in Patients With Low Back Pain.
The tape will be applied on the lumbar area bilateralemten to the spine without creating any tension.
The possible variation in the range of motion in hip flexion is measured with the KInovea program. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A triple-blind cross-sectional observational study is designed where subjects with low back pain will be selected and blinded to receive the Magnetic Tape® (tape with magnetic effects of less than 2 Gauss) or placebo Tape. Likewise, the evaluator who puts the Magnetic Tape® does not know what material he is using, as it is supplied by another researcher. The patient does not know what tape will be placed on him.
The recommendations of the "Consolidated Standards of Reporting Trials" (CONSORT) will be followed. All participants will receive a participant information sheet and sign informed consent. Patients aged 18 to 65 years with low back pain will be recruited from different private clinics in the city of Valencia, Spain.
The hypothesis is that when Magnetic Tape® comes into contact with electromagnetic fields such as those generated by living beings, due to the movement of electrical charges (ions), as defined by Ampere's Law, the domains of the tape are oriented or aligned in parallel with the external magnetic field creating a magnetic flux with a north pole and a south pole. This generated field in turn produces a magnetic induction proportional to the variation of the magnetic flux, as defined by the Faraday Law.
This electric potential produces a redistribution of the electric charge (ions) generating a magnetic field due to the orientation of the tape domains, then exerting a force on the moving charges within the electrolyte.
Physiological, Lorentz's Law, regulating Magnetic Tape® aberrant electromagnetic fields.
The protocol for data collection will be as follows:
After signing the informed consent and data protection, the groups with low back pain will be formed that will receive the application of both Magnetic Tape® and the intervention of a placebo tape. To avoid that the order of the intervention influences the results of the study, the subjects will be randomized into two different groups, Group A and Group B. Group A will receive Magnetic tape® and Group B will do the opposite. The next day the other tape will be applied Passive joint flexion of both hips is assessed by placing the patient in a supine position. The video camera is located paralelar to the hip to make recordings and measurements.
The tapes will be placed on the paravertebral skin from L1 to L5 without creating tension.
Subsequently, both hips are assessed again, performing hip flexion again and recording the degrees of range of motion.
Each subject will be your control since one day a tape will be placed and the next day the other.
Tipo de estudio
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subjects with low back pain.
- Subjects aged 18-65 years.
Exclusion Criteria:
- Tape allergies
- Adhesive allergies
- Pregnant
- People with pacemakers
- People who have any contraindication of electromagnetic fields
- People with neurological diseases
- Taking any medication that may interact with magnetic fields.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: No Intervention:hip flexion
hip flexion pre measurement with extension knee will be performed
|
|
|
Experimental: Experimental: hip flexion
hip flexion post experimental application measurement with Magnetic tape Application with extension knee will be performed
|
La cinta magnética® se aplica sin crear ninguna tensión sobre la parte baja de la espalda.
|
|
Comparador de placebos: Placebo Comparator: hip flexion
hip flexion post placebo application measurement with kinesiology tape Application with extension knee will be performed
|
Kinesiology Tape se aplica sin crear ninguna tensión sobre la parte baja de la espalda
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hip flexion
Periodo de tiempo: Changes from Range of motion first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape.
|
Maximum degrees of hip flexion measured with the Kinovea® program.
Validated Video Program
|
Changes from Range of motion first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- 3
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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