- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07657195
Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstruction (ACLR)
Effects of Dry Needling on Quadriceps Muscle Strength in Acute Post-Operative Anterior Cruciate Ligament Reconstruction With Quadriceps Autograft in the Pediatric Population
Dry needling is a skilled intervention provided by trained physical therapists to treat pain, myofascial dysfunction, and a variety of other diagnosis. While there is research demonstrating the benefits of dry needling in reduction of pain and improvement in strength, research in regards the pediatric population is very limited. A recent retrospective chart review regarding dry needling trends and outcomes in the pediatric orthopedic population showed the pediatric population is tolerating this treatment and seeing benefits. Physical therapists are already pushing the boundaries and finding additional benefits in the use of dry needling with current patients. A diagnosis frequently seen in sports medicine is surgical reconstruction of the anterior cruciate ligament (ACL). Over the last couple of years, therapists have seen an increase in the use of quadriceps tendon autograft for reconstruction following ACL tears due to lower incidence rate of retears. Patients have been struggling to regain strength of the quadriceps to meet desired outcomes. The quadricep muscles are one of the major stabilizers of the knee and with a reduction in strength places the patient at a significant increase of retear.
Subjects will be categorized into an experimental group (dry needling intervention + physical therapy) or the control group (physical therapy only) with a N of 20 in each group.
The goal for this research is to determine if dry needling use in the subacute phase of post-operative ACLR following quadriceps autograft can assist with increasing quad strength and improve post-surgical outcomes.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mellony J Mann, DPT
- Número de teléfono: 913- 717-4750
- Correo electrónico: mjmann@cmh.edu
Copia de seguridad de contactos de estudio
- Nombre: Shannon R Margherio, PT
- Número de teléfono: 816-816-6927
- Correo electrónico: srmargherio@cmh.edu
Ubicaciones de estudio
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Kansas
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Kansas City, Kansas, Estados Unidos, 66111
- Children's Mercy Sports Medicine Center- Village West
-
Contacto:
- Mellony R. Mann, DPT
- Número de teléfono: (913) 717-4750
- Correo electrónico: mjmann@cmh.edu
-
Contacto:
- Shannon Margherio, PT
- Número de teléfono: 816-816-6927
- Correo electrónico: srmargherio@cmh.edu
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Overland Park, Kansas, Estados Unidos, 66223
- Children's Mercy - Blue Valley
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Contacto:
- Mellony R. Mann, DPT
- Número de teléfono: (913) 717-4750
- Correo electrónico: mjmann@cmh.edu
-
Contacto:
- Shannon Margherio, PT
- Número de teléfono: 816-816-6927
- Correo electrónico: srmargherio@cmh.edu
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital- Kansas City
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Contacto:
- Mellony R. Mann, DPT
- Número de teléfono: (913) 717-4750
- Correo electrónico: mjmann@cmh.edu
-
Contacto:
- Shannon Margherio, PT
- Número de teléfono: 816-816-6927
- Correo electrónico: srmargherio@cmh.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Status post subacute quadriceps autograft 6 weeks or less
- Ages 10-20 years
- English and/or Spanish speaking
Exclusion Criteria:
- History of surgery on the knee or hip on the testing lower extremity.
- Any surgical intervention to other ligamentous or meniscus structures during time of ACLR
- Any post-surgical complications such as infection
- Current pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Dry Needling Group
For the Intervention Group, dry needling will be completed to the quadriceps muscle.
Strength measurements will be taken using a handheld dynamometer in post-operative weeks 6, 7, and 9.
|
Dry needling is defined as a skilled intervention that utilizes a thin filiform needle to stimulate underlying myofascial trigger points, muscular, and connective tissue in managing pain and movement dysfunction. For the Intervention Group, dry needling will be completed to the quadriceps as stated below. Two sessions of dry needling will be done once per week starting in week 6 and finishing by end of week 7. The patient will be laying in supine. Needles will be placed in the quadriceps muscle. Placement will be at identified trigger points or in mid muscle belly if no trigger point is identified. Electrical stimulation will be applied and increased to an intensity of the patient's tolerance with a visual contraction noted. Electrical stimulation will remain on for 5 minutes. |
|
Sin intervención: Control Group (No dry needling)
Participants will not receive dry needling intervention.
Strength measurements will be taken using a handheld dynamometer in post-operative weeks 6, 7, and 9.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Quadriceps Muscle Strength
Periodo de tiempo: Muscle strength measurements taken at post-operative week 6, 7, and 9.
|
Muscle strength measurement will be taken with use of the handheld dynamometer and use of stabilizing gait belt.
A max force production will be created over three seconds.
Three trials will be recorded, and average will be used as the final number.
For the intervention group, measurements will be taken immediately prior to dry needling and immediately following dry needling for both sessions of intervention (week 6 and week 7).
Additional post intervention measurements will be taken 2 weeks following dry needling intervention (week 9).
For the Control Group, measurements will be taken during week 6, week 7, and week 9. Measurements will be taken at the start of the physical therapy visit.
|
Muscle strength measurements taken at post-operative week 6, 7, and 9.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mellony J Mann, DPT, Children's Mercy Hospital Kansas City
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00003889
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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