- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07624136
Effects of Kinesio Taping on Thoracolumbar Fascia Flexibility in Patients With Shoulder Injury
Effects of Kinesio Taping on Thoracolumbar Fascia Flexibility in Patients With Subacromial Impingement Syndrome
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Subacromial Impingement Syndrome (SIS) is one of the most common causes of shoulder pain and is characterized by pain, movement limitation, and functional impairment. Contemporary biomechanical perspectives suggest that shoulder function is influenced not only by local anatomical structures but also by proximal structures such as the thorax, spine, and thoracolumbar fascia. The thoracolumbar fascia plays an important role in force transmission between the upper and lower extremities and contributes to postural control and movement coordination. Therefore, interventions targeting the thoracolumbar fascia may influence shoulder function and related clinical outcomes.
This randomized controlled trial will include a total of 60 participants diagnosed with Subacromial Impingement Syndrome. Participants will be randomly assigned into two groups: an intervention group receiving fascia correction Kinesio Taping using the Ram's Head technique applied to the thoracolumbar fascia, and a control group receiving sham Kinesio Taping without therapeutic fascia correction.
In the intervention group, Y-shaped Kinesio Tape will be applied to the thoracolumbar region using the fascia correction technique. Low-to-moderate tape tension (10-50%) combined with manual oscillatory movements will be used to facilitate fascial mobilization and modulate tissue glide capacity. The sham group will receive taping without therapeutic fascial correction.
Assessments will be performed immediately before the intervention and 45 minutes after tape application. Outcome measures will include pain intensity during rest and activity assessed using the Visual Analog Scale (VAS), trunk range of motion measured by goniometry, trunk flexibility assessed by tape measurements, thoracolumbar fascia flexibility evaluated using a goniometric platform, lumbar mobility assessed by the Modified Schober Test, and posterior shoulder capsule tightness measurement.
The primary aim of this study is to investigate the acute clinical effects of fascia correction Kinesio Taping applied to the thoracolumbar fascia in individuals with Subacromial Impingement Syndrome and to provide evidence regarding the potential effects of fascial modulation on pain, mobility, range of motion, and tissue flexibility.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: GÜL BALTACI, Prof. Dr.
- Número de teléfono: +905323963279
- Correo electrónico: ygulbaltaci@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: KÜBRA SARIOĞLU, PhD
- Número de teléfono: +905369370561
- Correo electrónico: fztkubrasarioglu@gmail.com
Ubicaciones de estudio
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Altindag
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Ankara, Altindag, Turquía (Türkiye), 06100
- Reclutamiento
- Hacettepe Sporcu Sağlığı Ünitesi
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Contacto:
- KÜBRA SARIOĞLU, PhD
- Número de teléfono: 05369370561
- Correo electrónico: fztkubrasarioglu@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- age between 20 and 40 years,
- Body Mass Index (BMI) within the normal range (20-24.9 kg/m²),
- a chronic (symptoms persisting for >3 months) SIS diagnosis
Exclusion Criteria:
- any shoulder pathology other than SIS (e.g., rotator cuff tear, glenohumeral joint problems),
- inability to perform 90° shoulder flexion due to joint limitation or pain ≥8 on the VAS,
- overweight or obesity (BMI >25 kg/m²),
- previous back surgery,
- low back pain within the last six months, scoliosis, radiologically diagnosed kyphosis or thoracolumbar disc herniation, sacroiliac joint problems, restricted pelvic range of motion (anterior-posterior pelvic tilt), and scapular dyskinesia.
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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Comparador activo: Kinesio Taping Group
Participants in this group will receive the "Ram's Horn" fascia correction technique using Kinesio Taping applied to the thoracolumbar fascia region.
The base (anchor) of a Y-shaped kinesiology tape will be applied without tension between the lateral iliac crest and the axillary line.
From this anchor point, the tape will be divided into two tails.
The first tail will be directed superiorly over the scapular region and attached along the superior border of the scapula.
The second tail will be directed inferiorly and posteriorly across the lumbar region toward the superior aspect of the iliac crest, creating a configuration resembling a ram's horn.
During the application of both tape tails, oscillatory fascial correction movements will be performed manually by shifting the underlying fascia while the tape is applied.
No tension will be applied to the anchor portion of the tape.
The technique is intended to provide a fascial correction effect throughout the thoracolumbar region.
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Assessments will be performed immediately before the intervention and 45 minutes after tape application in both groups.
Outcome measures will include pain intensity during rest and activity assessed using the Visual Analog Scale (VAS), trunk range of motion measured by goniometry, trunk flexibility assessed by tape measurements, thoracolumbar fascia flexibility evaluated using a goniometric platform, lumbar mobility assessed by the Modified Schober Test, and posterior shoulder capsule tightness.
Participants in the intervention group will receive corrective kinesio taping applied in a horn-shaped configuration, whereas the sham group will receive a tension-free tape application from the lateral trunk/axillary region toward the hip without therapeutic fascial correction.
Otros nombres:
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Comparador falso: control group
Participants in the sham group will receive a placebo taping application using a Y-shaped kinesiology tape.
The tape will be applied without tension and without the oscillatory fascial correction maneuvers used in the Ram's Horn technique.
The anchor will be placed near the axillary region, and both tails of the Y-shaped tape will be directed inferiorly toward the iliac crest in a random, non-corrective configuration.
The tape will not be arranged in the characteristic ram's horn pattern and will be applied without any intended therapeutic fascial correction effect.
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Assessments will be performed immediately before the intervention and 45 minutes after tape application in both groups.
Outcome measures will include pain intensity during rest and activity assessed using the Visual Analog Scale (VAS), trunk range of motion measured by goniometry, trunk flexibility assessed by tape measurements, thoracolumbar fascia flexibility evaluated using a goniometric platform, lumbar mobility assessed by the Modified Schober Test, and posterior shoulder capsule tightness.
Participants in the intervention group will receive corrective kinesio taping applied in a horn-shaped configuration, whereas the sham group will receive a tension-free tape application from the lateral trunk/axillary region toward the hip without therapeutic fascial correction.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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thoracolumbar fascia flexibility
Periodo de tiempo: 15 minutes
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The flexibility of the thoracolumbar fascia was evaluated using a goniometric platform.
A goniometric platform was placed on a table in front of the participants.
Patients were asked to clasp their hands in front at 90° of shoulder flexion, holding a wooden marker between their hands.
Patients performed maximum trunk rotation, first to the right and then to the left, while ensuring their arms followed the movement of the trunk.
The rotation degree reached by the marker was recorded on the goniometric platform.
The test was repeated three times for each direction with one-minute rest intervals, and the average values were recorded.
A decrease in rotation range during repeated trials or restricted movement was considered indicative of TLF tightness.
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15 minutes
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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pain assessment, rest and active
Periodo de tiempo: 3 minutes
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Pain intensity was evaluated using a 10 cm VAS (0: no pain, 10: worst pain).
Measurements were recorded at baseline and 45 minutes post-taping in two conditions: Resting Pain: Pain level while the participant was in a relaxed position.
Activity Pain: Pain level during basic activities, such as arm movements and walking.
The distance between the marked point and the zero point was measured in centimeters using a ruler
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3 minutes
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Modified schober test
Periodo de tiempo: 5 minutes
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The physiotherapist determined the SIPS with a pencil.
The midpoint of the line connecting the Spina İliaca Posterior Superior (SIPS) is marked.
The point 10 cm above and 5 cm below this point was determined with a tape measure.
The person was asked to perform maximum trunk flexion.
The distance between these two points was measured.
The difference was less than 5 cm, indicating low back flexibility
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5 minutes
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Shoulder posterior capsule shortness:
Periodo de tiempo: 5 minutes
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Shoulder posterior capsule shortness was measured and evaluated with a tape measure.
Participants were positioned in a side-lying position at the edge of the examination table.
The scapula of the measured side was stabilized by the physiotherapist.
The shoulder was moved into horizontal adduction and the arm was allowed to drop toward the table.
The distance between the olecranon and the table surface was measured and recorded in centimeters
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5 minutes
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Trunk Range of Motion:
Periodo de tiempo: 5 minutes
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The ROM values were evaluated using a goniometer.
The results were recorded in degrees (°) for lateral flexion, flexion and extension directions
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5 minutes
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Trunk flexibility
Periodo de tiempo: 5 minutes
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both sides rotation, lateral flexion and extension
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5 minutes
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: KÜBRA SARIOĞLU, PhD, HACETTEPE ÜNİVERSİTESİ ,Anafartalar, Talatpaşa Blv No:47, 06100 Altındağ/Ankara
- Director de estudio: Gül Baltacı, Prof.Dr., Atlas University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- HU-FTR-KS-03
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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