- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05104957
Evaluation of the Kinesiology Taping Effectiveness in the Treatment of Lumbar Spine Pain
Evaluation of the Kinesiology Taping Effectiveness in the Treatment of Lumbar Spine Pain in Subjects Under 30 Years of Age
Lumbar spine pain syndromes are one of the most common pain conditions in our society.
The purpose of kinesiotaping is to normalize muscle function, improve blood and lymph flow, reduce pain, improve proprioception, promote tissue healing and restore normal tissue function. Today, this method is used in many fields of medicine. Its primary purpose is to support the musculoskeletal system by using various types of applications.
There is a lack of publications in the global literature on the effect of kinesiotaping of the external oblique muscles on lumbar spine pain. The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Back pain occurs in people of all ages, regardless of their job. Both blue-collar and white-collar workers are exposed to strain and pain in the lumbar spine. The presence of pain is also promoted by low physical activity, poor motor habits, as well as stress.
There are numerous factors affecting the quality of life in patients with lower back pain. These include degree of pain, physical fitness, individual factors, degree of social support, and a potential for adapting forces to match constantly changing conditions.
The contemporary functional model of lumbar spinal muscles divides them into local stabilizers, single-joint global stabilizers, and multi-joint global stabilizers. The abdominal external oblique muscles are classified as global stabilizers. They generate force to control range of motion and allow limitation of that range (eccentric control), and functionally control rotation in all movements, regardless of the load acting on the spine.
The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Biała Podlaska, Polonia, 21-500
- Pope John Paul II State School Of Higher Education in Biała Podlaska
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Biała Podlaska, Polonia
- Laboratory of Pope John Paul II State School Of Higher Education in Biala Podlaska
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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:
- participants' age between 18 and 30,
- the presence of pain in the lumbar region of the spine,
- participants who have not been using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to study entry,
- no contraindications to the use of dynamic kinesiology taping patches,
- informed, written consent to participate in the study.
Exclusion Criteria:
- status of the post lumbar spine surgery,
- subjects who have had a spinal injury within 6 months prior to the start of the study,
- neoplastic diseases,
- congenital structural pathologies of the spine,
- allergy to the adhesive substance of kinesiology taping or paper patch,
- being a physiotherapy student.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Dynamic tape
Experimental group will use a special dynamic tape on the lumbar extensor muscles
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The experimental group will use a special dynamic patch made of cotton, coated with a hypoallergenic acrylic heat-activated adhesive arranged in sinusoidal-shaped layers.
The tape will be applied using the muscle technique with a Y-shaped cut patch directly to the dried and non-greased skin.
The application will be performed in a standing position, with the participant's lower extremities straight.
The therapist will place the beginning of the tape (the base) on the participant's sacrum and then, asking them to bend 45 degrees forward, tape the tails of the tape along the spine on the extensor muscles of the lumbar region, without changing the tension of the tape, keeping the base in the initial position.
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Comparador falso: Paper tape
Control group will use a paper tape on the lumbar extensor muscles
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In the control group, a plain paper patch will be used to conduct the study, which, like the dynamic patch, will be applied using the same form of tape cutting and the same application technique.
The entire method of applying the patch will also take place in the participant's standing position with forward bending.
The paper patch will be placed at the levels from the L3 segment to the sacrum, along the spine on the lumbar extensor muscles.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Visual analogue scale of pain (VAS)
Periodo de tiempo: Visual analogue pain scale (VAS) will be carried out before the start of the therapy.
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Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
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Visual analogue pain scale (VAS) will be carried out before the start of the therapy.
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Visual analogue scale of pain (VAS)
Periodo de tiempo: Visual analogue pain scale (VAS) will be carried out 4 days of therapy, immediately after its completion.
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Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
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Visual analogue pain scale (VAS) will be carried out 4 days of therapy, immediately after its completion.
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Visual analogue scale of pain (VAS)
Periodo de tiempo: Visual analogue pain scale (VAS) will be carried out four weeks after the end of the treatment.
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Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
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Visual analogue pain scale (VAS) will be carried out four weeks after the end of the treatment.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Modified Laitinen's pain questionnaire
Periodo de tiempo: Modified Laitinen's pain questionnaire will be carried out three times (before the start of the therapy, after 4 days of therapy, immediately after its completion and four weeks after the end of the treatment
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The Laitinen questionnaire takes into account four indicators evaluated in a scale of 0 to 4: the intensity of pain, the frequency of its occurrence, the use of analgesic medications and limitation of the participant's motor activity.
A research participant could be granted from 0 to 16 points, the maximum score meaning the highest level of pain.
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Modified Laitinen's pain questionnaire will be carried out three times (before the start of the therapy, after 4 days of therapy, immediately after its completion and four weeks after the end of the treatment
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Oswestry Disability Index
Periodo de tiempo: Oswestry Disability Index will be carried out three times (before the start of the therapy, after 4 days of therapy, immediately after its completion and four weeks after the end of the treatment
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Oswestry Disability Index takes into account ten indicators evaluated in a scale of 0 to 5. A research participant could be granted from 0 to 50 points, the minimum score meaning the highest level of disability.
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Oswestry Disability Index will be carried out three times (before the start of the therapy, after 4 days of therapy, immediately after its completion and four weeks after the end of the treatment
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Colaboradores e Investigadores
Investigadores
- Silla de estudio: Kamil Zaworski, Ph.D., John Paul II University of Applied Sciences in Biala Podlaska
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
- PopeJohnPaulIIStateSchHigherE2
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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