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MECHANICAL TRACTION APPLIED BEFORE VERSUS AFTER THERAPEUTIC EXERCISES IN PRIMARY KNEE OSTEOARTHRITIS (MT-KOA)

22 de mayo de 2026 actualizado por: HEBA AHMAD AWAD ABDELRAZEK, Cairo University

EFFECT OF MECHANICAL TRACTION APPLIED BEFORE VERSUS AFTER THERAPEUTIC EXERCISES ON CLINICAL AND FUNCTIONAL OUTCOMES IN PRIMARY KNEE OSTEOARTHRITIS

To study the effect of application of mechanical traction before versus after therapeutic exercises and exercise alone ,on pain severity , disability , knee joint range of motion , knee joint position sense , knee isometric muscle strength and functional performance in patients with primary knee OA.

Descripción general del estudio

Descripción detallada

OA is widespread condition and a major contributor to disability in the United States and globally . In Egypt, the one-year prevalence of knee OA ranges from 6.6% to 9.25% . OA is associated with functional impairments and diminished quality of life . OA ensues a substantial social and economic burden, including healthcare expenses, lifestyle modifications, and reduced work productivity . Therapeutic exercise is widely recognized as an effective intervention for knee OA. It may slow cartilage degeneration, attenuate inflammation, and reduce the loss of subchondral bone. Growing evidence demonstrates that exercise improves pain, stiffness, joint function and muscle strength in patients with knee OA . Additionally, strong evidence suggests that exercise effectively improve knee proprioception and decrease knee joint repositioning error . Evidence suggests that addition of therapeutic exercise to other noninvasive methods that routinely are used for knee OA have a boosting effect in relieving pain and improving knee function . Recent studies report that mechanical traction can reduce knee pain and enhance physical function in patients with knee OA . It can also provide joint gapping and temporary joint unloading that suppress articular cartilage degeneration . Applying mechanical traction may also stimulate mechanoreceptors, thereby improving joint position sense and neuromuscular control. Despite its clinical use, there is limited evidence regarding the optimal sequencing of mechanical traction in relation to therapeutic exercises. Findings support that the addition and the application of mechanical traction after conventional physiotherapy contributes to better pain reduction and improvement in physical activity in patients with knee OA . Findings also support that the addition and the application of mechanical traction before therapeutic exercises was reported to reduce pain and disability; improve functional performance, isometric quadriceps & hamstring muscle strength in patients with knee OA . Understanding whether the timing of mechanical traction influences pain severity, disability, range of motion, proprioception, muscle strength, and functional performance is essential for optimizing rehabilitation protocols. Previous studies have primarily investigated outcomes such as pain and disability , isometric muscle strength, functional performance However, up to the author's knowledge no study investigated the effect of mechanical knee joint traction on knee proprioception (joint position sense) in patients with knee osteoarthritis.

Therefore, the aim of this randomized controlled trial to investigate the effect of application of mechanical traction before versus after therapeutic exercises and exercise alone ,on pain severity , disability, knee joint range of motion , knee joint position sense , knee isometric muscle strength and functional performance in patients with primary knee OA.

A total of 63 patients aged 50 to 56 years with knee OA. Patients will be randomly assigned into three groups. Group A, exercise group will receive therapeutic exercises Group B ,Traction & exercise group will receive mechanical knee joint traction followed by the same therapeutic exercises of 1st group .Group C, • Exercise & traction group will receive the same therapeutic exercises of 1st group followed by mechanical knee joint traction. All groups will receive 18 sessions, 3 times per week each other day for 6 weeks. Adherence will be ensured using attendance logs and checklists. Outcome measures will include pain severity measured using Arabic Numeric Pain Rating Scale (NPRS-Ar), disability measured using Arabic Version Of Western Ontario And Mcmaster Universities Osteoarthritis Index (WOMAC-Ar) , flexion/ extension knee joint ROM measured using digital goniometer, knee joint position sense (active knee joint repositioning test) measured using Dual digital inclinometer , quadriceps/ hamstring isometric muscle strength measured using hand Held Dynamometer (HHD) and functional performance measured using 12 Steps Stairs Climb Test (12SS_CT).

All assessments will be conducted at baseline (pre-treatment; 24-48 hrs. before the first treatment session) and after 6 weeks of intervention (post-treatment; 24-48 hrs. before the first treatment session

Tipo de estudio

Intervencionista

Inscripción (Estimado)

63

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Cairo, Egipto
        • Faculty of physical therapy in Cairo university
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Heba Ahmad Awad, PhD

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Patients with grade II or III primary knee OA .
  • Patients with bilateral primary knee OA, the more painful knee will be selected as the affected knee .
  • Duration of illness will be more than 3 months
  • Age of patients will range from 50-65
  • Body Mass Index (BMI) between 25 and 35 kg/m²

Exclusion Criteria:

  • Rheumatoid arthritis .
  • Intra-articular knee joint injection in the last three months
  • Previous knee surgeries .
  • Malignancy, infections or knee joint instability .
  • Pregnancy .
  • Patients who have received physical therapy on the knee within the last 3 months.

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Group A : exercise group
Group A : will receive therapeutic exercises (Stretching and Strengthening Exercises for all major lower-limb muscles), Stretching will be performed(Rectus femoris, hamstring, calf muscle) for 1 set of 3 repetitions, 30 seconds hold, a rest period of 30 seconds between repetitions. Stretching will be carried out slowly and in a controlled manner until the feeling of mild tightness or discomfort. Strengthening exercises for (Knee extensors, knee flexor, hip extensor, hip flexor, hip abductor, hip external rotator, ankle dorsi flexor and plantar flexor) will be performed for 3 sets of 10 repetitions each, 10 seconds hold, a rest period of 2 seconds between repetitions and 30 seconds between sets. The resistance will be applied using sandbags and therabands of different weight and tension. The initial resistance will be determined based on 10RM, and the resistance will progress each week
therapeutic exercises (Stretching and Strengthening Exercises for all major lower-limb muscles), Stretching will be performed(Rectus femoris, hamstring, calf muscle) for 1 set of 3 repetitions, 30 seconds hold, a rest period of 30 seconds between repetitions. Stretching will be carried out slowly and in a controlled manner until the feeling of mild tightness or discomfort. Strengthening exercises for (Knee extensors, knee flexor, hip extensor, hip flexor, hip abductor, hip external rotator, ankle dorsi flexor and plantar flexor) will be performed for 3 sets of 10 repetitions each, 10 seconds hold, a rest period of 2 seconds between repetitions and 30 seconds between sets. The resistance will be applied using sandbags and therabands of different weight and tension. The initial resistance will be determined based on 10RM, and the resistance will progress each week
Experimental: Group B: Traction and exercise group
Group B : will receive mechanical knee joint traction followed by the same therapeutic exercises of 1st group Mechanical traction will be applied for 20 minutes continuously in the supine lying position with the affected knee flexed at 25-30° (where joint structures are the most relaxed and the maximum amount of joint play is enabled) by a wedge placed under the thigh, before starting, the angle will be measured using a goniometer. The thigh will be stabilized by a strap and the leg will be held by the specially designed greave with the weight of traction hanging throughout the pulley system. The initial traction force will be set at 10% of the body weight. Traction force will be increased each week by 1% of body weight if the patient could tolerate
Mechanical traction will be applied for 20 minutes continuously in the supine lying position with the affected knee flexed at 25-30° (where joint structures are the most relaxed and the maximum amount of joint play is enabled) by a wedge placed under the thigh, before starting, the angle will be measured using a goniometer. The thigh will be stabilized by a strap and the leg will be held by the specially designed greave with the weight of traction hanging throughout the pulley system. The initial traction force will be set at 10% of the body weight. Traction force will be increased each week by 1% of body weight if the patient could tolerate then the same exercise of the firs group will be applied .
Experimental: Group C: Exercise and traction group
Group C: will receive the same therapeutic exercises of 1st group followed by mechanical knee joint traction
This group will receive the same therapeutic exercises of 1st group followed by mechanical knee joint traction

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
pain severity
Periodo de tiempo: pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs.
Arabic Numeric Pain Rating Scale; NPRS-Ar 0-10 scale
pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs.
Disability
Periodo de tiempo: pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs
Arabic Version Of Western Ontario And Mcmaster Universities Osteoarthritis Index (WOMAC-Ar)
pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs
Knee Joint Range Of Motion
Periodo de tiempo: at baseline (pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment
Easy Angle Digital Goniometer
at baseline (pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment
Knee Joint Position Sense (JPS
Periodo de tiempo: at baseline (pre-treatment; 24-48 hrs before the first treatment session) and after 6 weeks of intervention post-treatment; 24-48 hrs.
Digital Inclinometer
at baseline (pre-treatment; 24-48 hrs before the first treatment session) and after 6 weeks of intervention post-treatment; 24-48 hrs.
Isometric Knee Muscle Strength
Periodo de tiempo: at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment; 24-48 hrs.
handheld dynamometer
at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment; 24-48 hrs.
Functional performance
Periodo de tiempo: at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention(post-treatment; 24-48 hrs
12-step stair climb test (12 _SSCT)
at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention(post-treatment; 24-48 hrs

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Heba Ahmad Awad, PhD, Cairo University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de julio de 2027

Finalización del estudio (Estimado)

1 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2026

Publicado por primera vez (Actual)

29 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • P.T.REC/012/006479

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

sensitive patient data

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

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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