Effectiveness of Lateral Wedge Insole on Knee Osteoarthritis Outcomes in Pakistani Population
26 de octubre de 2021 actualizado por: Rabbiya Riaz, Isra University
Osteoarthritis (OA) is a persistent joint disorder, which normally affects the weight bearing joints especially knee joint.
Lateral wedge insole is one such approach suggested by professionals to manage the knee osteoarthritis.Effectiveness of lateral wedge insoles (LWI) group (n=20), and conventional physical therapy (CPT) group (n=20) with home exercises as baseline treatment were assessed on Urdu version of Knee Injury and Osteoarthritis Outcome Score scale (KOOS).
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
A total of n=104 patients were recruited through the non-probability convenience sampling technique and were thus evaluated for the inclusion criteria.
Of which, n=40 participants fulfilled the inclusion criteria.
Participants were randomly divided through the sealed envelope method in two groups; lateral wedge insoles with home exercises group (n=20), and traditional physiotherapy with home exercises group (n=20).
The data was collected through a general demographic questionnaire and Knee injury and Osteoarthritis Outcome Score (KOOS) in Urdu to determine the severity of pain, stiffness, functional activities, recreational activities and Quality of life to promote functional independence in osteoarthritic patients.[20]
The level of significance was set at p<0.05.
Statistical Package for the Social Sciences (SPSS) ver.
23 was used for data analysis.As the assumption of the parametric test was met, mixed ANOVA was used for the interaction effect of between-subject factor (group) and within-subject factor (time).
With-in group analysis and one way ANOVA was used for between-group comparisons to determine the effect size (ɳp2).
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Punjab
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Islamabad, Punjab, Pakistán
- Rabbiya Riaz
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients with the age criteria of 40-70 years, and who had a history of knee OA were included in the study.
Exclusion Criteria:
- Patients had knee OA due to trauma or any pathology, multiple fractures, or had a medical condition due to which rehabilitation wasn't possible, and not willing to participate in the clinical trials were excluded from the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Lateral wedge insoles with home exercises group(Group 1)
In this group, participants were advised to use lateral wedge insole during walking and long-standing.
Non customized full-length lateral wedge insoles of 7mm made of silicon material with 5 degrees angulation (because greater wedging is associated with foot discomfort) was used.
Full-length wedge extends under the lesser metatarsal heads which increases the lever arm for rearfoot eversion and thus can prevent subtalar joint rotation.
The evaluations were performed every week till fourth week.
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In this group, participants were advised to use lateral wedge insole during walking and long-standing.
Non customized full-length lateral wedge insoles of 7mm made of silicon material with 5 degrees angulation (because greater wedging is associated with foot discomfort) was used.
Full-length wedge extends under the lesser metatarsal heads which increases the lever arm for rearfoot eversion and thus can prevent subtalar joint rotation.
The evaluations were performed every week till fourth week.
|
|
Comparador activo: Traditional physiotherapy with home exercises group (Group 2)
Each participant received 40-45 minutes long session, started in lying position.
The therapeutic low-intensity pulsed ultrasound (US) was used for 7 minutes with the frequency of 1 MHz, Spatial Average Intensity was 0.2 W /cm2, pulsed duty cycle 20%, therapeutic dose was 112.5 J/cm2 with fixed application on the medial side of the knee joint.
The model of US was Unit Intelect Mobile, (Chattanooga Inc).
After US therapy passive stretching of calf, hamstring, quadriceps, hip flexors, adductors & abductor s was done, which was followed by the manual strengthening exercises and strengthening with quadriceps bench.
The session was repeated thrice a week and 12 sessions per month.
The home program was guided in both groups including avoiding low sitting, cross leg sitting along with Isometrics of quadriceps atleast 3 times a day, with 5-10 seconds hold of each contraction.
|
Each participant received 40-45 minutes long session, started in lying position.
The therapeutic low-intensity pulsed ultrasound (US) was used for 7 minutes with the frequency of 1 MHz, Spatial Average Intensity was 0.2 W /cm2, pulsed duty cycle 20%, therapeutic dose was 112.5 J/cm2 with fixed application on the medial side of the knee joint.
The model of US was Unit Intelect Mobile, (Chattanooga Inc).
After US therapy passive stretching of calf, hamstring, quadriceps, hip flexors, adductors & abductor s was done, which was followed by the manual strengthening exercises and strengthening with quadriceps bench.
The session was repeated thrice a week and 12 sessions per month.
The home program was guided in both groups including avoiding low sitting, cross leg sitting along with Isometrics of quadriceps atleast 3 times a day, with 5-10 seconds hold of each contraction.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knee injury and osteoarthritis outcome pain score
Periodo de tiempo: Upto 4 weeks
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Pain associated with daily tasks is measured through Knee injury and osteoarthritis outcome pain score with categories as 'None' for no pain and 'Extreme' for maximum pain value.
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Upto 4 weeks
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Knee injury and osteoarthritis outcome stiffness score
Periodo de tiempo: Upto 4 weeks
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It is measured through Knee injury and osteoarthritis outcome stiffness score with categories as 'None' for no stiffness and 'Extreme' for maximum stiffness.
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Upto 4 weeks
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Knee injury and osteoarthritis outcome functional status score
Periodo de tiempo: Upto 4 weeks
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Degree of difficulty in performing daily tasks associated with knee joint is measured through Knee injury and osteoarthritis outcome functional status score with categories as 'None' for no difficulty in tasks and 'Extreme' for maximum difficulty in performing tasks. .
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Upto 4 weeks
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Knee injury and osteoarthritis outcome quality of life score
Periodo de tiempo: Upto 4 weeks
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Quality of life regarding knee joint disease is measured through Knee injury and osteoarthritis outcome quality of life score with categories as according to patient's satisfaction.
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Upto 4 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de septiembre de 2020
Finalización primaria (Actual)
20 de junio de 2021
Finalización del estudio (Actual)
20 de junio de 2021
Fechas de registro del estudio
Enviado por primera vez
26 de octubre de 2021
Primero enviado que cumplió con los criterios de control de calidad
26 de octubre de 2021
Publicado por primera vez (Actual)
2 de noviembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de noviembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
26 de octubre de 2021
Última verificación
1 de octubre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BIHS-RABBIYA/Lecturer DPT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Formulario de consentimiento informado (ICF)
- Informe de estudio clínico (CSR)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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