- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04776798
Biomechanical Taping on Low Back Pain With Increased Foot Pronation
The Effects of Biomechanical Taping on Individuals With Mechanical Low Back Pain With Increased Foot Pronation
It is stated that abnormal lower extremity posture and biomechanics are effective in the development and progression of Low Back Pain (LBP). Exercise, electrotherapy, insoles, and orthoses are used for the prevention and treatment of low back pain.The use of orthosis, insoles, and taping techniques stands out in the correction of foot posture and dysfunctions, which are stated to cause LBP. In studies examining the application of taping to improve foot posture and biomechanics, it is stated that taping is effective in improving foot posture and biomechanics in the short term.
Biomechanical taping has been used in the treatment of musculoskeletal disorders in recent years. It is aimed to correct the impaired joint biomechanics by reducing the load on the joint, supporting strength, and providing movement modification.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
In this study, it is assumed that correction of "increased foot pronation" with dynamic taping will result in the recovery of increased internal rotation and decreased shock absorption during weight-bearing, which is stated to cause pain. The study aims to investigate the effects of biomechanical tapping in combination with a home exercise program on LBP.
Participants with a diagnosis of LBP and bilateral increased flexible foot pronation will divide into two groups (Biomechanical Taping (BT) group or Placebo Taping (PT) group). Tape applications will repeat twice per week, for 4 weeks. And also a home-based exercise program will apply to both groups.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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İstanbul
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Küçükçekmece, İstanbul, Pavo
- Ayşe Alpözgen
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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:
- Mechanical low back pain for at least 6 months
- Age between 18-65 years
- Increased, bilateral, flexible pronation of the feet (Foot Posture Index-6 score> 0)
Exclusion Criteria:
- Rigid pes planus, pes cavus, equinus deformity, hallux valgus, hallux rigid or calcaneal epin in the feet
- Lower extremity injury or surgery in the last 6 months
- Radicular type back pain (patients with leg pain> low back pain)
- Body Mass Index (BMI)> 30,
- Use of analgesics
- Pregnancy
- Presence of symptoms related to a history of spinal surgery in the last 5 years.
- Neurological impairment or cognitive dysfunction (stroke, dementia, etc.)
- Rheumatological diseases
- Peripheral vascular diseases
- Difference in length between extremities
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Biomechanical Taping
Anti pronation taping will apply bilaterally with Dynamic Tape®. The tape will attach to the dorsal aspect of the foot. A home-based exercise program will apply in the first session. Printouts showing the exercises will give to the patients. Exercises will be done at home for 4 weeks, 5 d/w. |
Tape applications will repeat twice per week, for 4 weeks.
|
|
Comparador de placebos: Placebo Taping
Placebo Taping will apply bilaterally to each individual in the control group by the same physiotherapist, without any effect on increased pronation. A home-based exercise program will apply in the first session. Printouts showing the exercises will give to the patients. Exercises will be done at home for 4 weeks, 5 d/w. |
Tape applications will repeat twice per week, for 4 weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Analog Scale (VAS)
Periodo de tiempo: 4 week
|
It is used to evaluate the level of pain.The activity, rest and night pain levels of the patients will be question.
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4 week
|
|
Foot Posture Index (FPI-6)
Periodo de tiempo: 4 week
|
FPI-6 examines foot posture under 6 headings: talar head palpation, supra and infra lateral malleoli curvature, calcaneal frontal plane position, prominence in region of talonavicular joint, congruence of medial longitudinal arch, abduction/adduction of forefoot on rearfoot.
Each measure is scored from -2 to 2. A total score of 0 is considered a neutral foot; a positive score is for pronated foot, whereas a supinated foot is given a negative score.
|
4 week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
6 Minute Walk Test (6MWT)
Periodo de tiempo: 4 week
|
The 6MWT provides an indirect assessment of physical performance and endurance capacity.the person is asked to walk for 6 minutes as fast as possible in the 30-meter straight corridor, the patient does not speak during walking, but is supported with motivating sentences at the end of every 1 minute.
After 6 minutes, the distance traveled (meters-m) is recorded.
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4 week
|
|
Step-On-Stool Test
Periodo de tiempo: 4 week
|
The person tested is asked to step up onto and down from a stool at a self-selected speed.
The step height is 0.40 meters for women, 0.44 meters for men.
The number of steps managed will be record.
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4 week
|
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PILE Lumbar Lifting Test
Periodo de tiempo: 4 week
|
The lumbar Spine is tested by asking to lift the box with a weight of 76 cm shelf from the ground to waist level.
The test starts with weights of 3.6 kg for women and 5.9 kg for men.
It is asked to lift the box containing weight 4 times in 20 seconds.
For each completed round, a weight of 2.25 kg for women and 4.5 kg for men are added to the box.
If the patient reaches 85% of the maximum heart rate, lifts 55-60% of his body weight, shows pain or fatigue after a 20-second interval, and cannot complete 4 repetitions within 20 seconds, the test is terminated.
The maximum weight lifted & the number of repetitions multiplied so total work done will calculate and record.
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4 week
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Revised Oswestry Disability Index
Periodo de tiempo: 4 week
|
; It is a self-administered questionnaire and consists of 10 sections.
Each section is scored between 1 and 5 (the highest score for the last question is 6), test scores range from 0 to 51.
An increase in the score is interpreted as an increase in disability
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4 week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ayse Zengin Alpozgen, PhD, Istanbul University - Cerrahpasa (IUC)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- 05.SKHEK
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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Ensayos clínicos sobre Taping
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-
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-
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-
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-
Atlas UniversityAún no reclutandoTiempo de reacción | Jugadores de baloncesto | Estabilidad del tobillo | Rendimiento de salto vertical | Rendimiento del Equilibrio
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-
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-
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