- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07710404
Effectiveness of Joint Distraction Versus Passive End Range Overpressure in Osteoarthritis:
Comparative Effectiveness of Joint Distraction Versus Passive End Range Overpressure in Managing Knee Osteoarthritis: A Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Punjab Province
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Faisalābad, Punjab Province, Pakistán, 3800
- The University of Faisalabad
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria
- Patients diagnosed with Grade 2 or Grade 3 Knee Osteoarthritis.
- A Kellgren-Lawrence Grade (KLG) of at least 2.
- Age between 40-60 years.
- Knee pain for at least 6 months.
- A minimum pain score of 3 on the Visual Analogue Scale (VAS).
Exclusion Criteria
- Acute inflammation.
- Total Knee Replacement (TKR) surgery.
- Any lumbar spine disease (disc herniation or lumbar stenosis).
- Intra-articular injection.
- Recent tibia or femur fracture.
- Any systemic inflammatory arthritic condition or neurological condition (e.g., rheumatoid arthritis or stroke).
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 |
|---|---|
|
Experimental: GROUP A
The joint distraction is the manual approach in knee osteoarthritis.
This is very efficient in managing pain, to increase range of motion and reduce stiffness of joint due to osteoarthritis.
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The joint distraction is the manual approach in knee osteoarthritis. This is very efficient in managing pain, to increase range of motion and reduce stiffness of joint due to osteoarthritis. A specialized greave would be created to distract the knee joint. Using a platform beneath the lower leg to create counterpressure, the knee would be put in flexion while sustained traction will be performed for 20 minutes while the patient would be in a supine posture. In each session, the traction would be adjusted to the patients' perceived threshold. The least amount of work that caused patients to get distracted would be employed as a diversion |
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Experimental: GROUP B
The passive joint end-range overpressure is the technique of Maitland grade IV which is performed passively.
End-range Individual Maitland mobilizations were carried out at the tibiofemoral joint.
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The passive joint end-range overpressure is the technique of Maitland grade IV which is performed passively.
End-range Individual Maitland mobilizations were carried out at the tibiofemoral joint.
Depending on the patient's level of pain and tolerance, an oscillatory accessory approach using Grade III or IV was carried out.
Patients positioned their knees in their true end range while lying supine on the plinth.
The most limited or reproducible knee pain was caused by the accessory approach that was employed.
By moving the therapist's body without making any additional movements, the physical contact accurately replicated the hand position of the mobilization.
For three minutes, Maitland mobilization was carried out twice at a rate of one oscillation every one or two seconds, with a 30-second break in between
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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pain intensity
Periodo de tiempo: 4 months
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Primary Outcome Measure Pain Tool Used: Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) was used to assess the patient's pain level. Participants were asked to rate their pain on a scale from 0 to 10. 0 = No pain 1-3 = Mild pain 4-6 = Moderate pain 7-10 = Severe pain This scale was used to categorize the intensity of pain experienced by patients with knee osteoarthritis. |
4 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of Life / Broader Function
Periodo de tiempo: 4 months
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Quality of Life / Broader Function Tool Used: KOOS Questionnaire (Knee Injury and Osteoarthritis Outcome Scale. The KOOS questionnaire was used to assess: Pain Symptoms Activities of Daily Living (ADLs) Sport and Recreation Function Knee-related Quality of Life It contains 42 items divided into five sections: Pain = 9 items Symptoms = 7 items Activities of Daily Living = 17 items Sport and Recreation Function = 5 items Quality of Life = 4 items Each item is scored from 0 to 4. Maximum score: 42 items × 4 = 168 Interpretation (Percentage Based): < 40% = Extreme disability 40-59% = Severe problems 60-79% = Moderate problems 80-99% = Mild disability This questionnaire evaluates the overall impact of knee osteoarthritis on function and quality of life.4 months |
4 months
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Disability
Periodo de tiempo: 4 months
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Secondary Outcome Measures 1) Osteoarthritis Symptoms and Functions Tool Used: WOMAC Questionnaire (Western Ontario McMaster Universities Osteoarthritis Index) The WOMAC questionnaire was used to assess: Pain Stiffness Physical function It contains 24 items divided into three sections: Pain = 5 items Stiffness = 2 items Physical Function = 17 items Each question has 5 response options ranging from None to Extreme. Scoring: Each item = 0-4 points Pain section total = 20 Stiffness section total = 8 Physical function section total = 68 Total WOMAC score = 96 Interpretation: 0-30 = Mild 31-60 = Moderate 61-96 = Severe The higher the score, the greater the symptoms and functional limitations. |
4 months
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Passive Range of Motion
Periodo de tiempo: 4 months
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Passive Range of Motion Tool Used: Goniometer A goniometer was used to assess joint range of motion. The instrument consists of three parts: Moving Arm - aligned with the body segment that moves. Stationary Arm - aligned with the body segment that remains stationary. Fulcrum - positioned over the joint being assessed. The goniometer was used to measure the knee joint's range of motion before and after treatment. |
4 months
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Colaboradores e Investigadores
Patrocinador
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TUF/EIRB/143/2025
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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