Effect Of Shock Waves Therapy On Post Natal De Quarvain Tenosynovitis
This randomized controlled trial aims to investigate the effect of extracorporeal shock wave therapy (ESWT) on pain, wrist and thumb range of motion, and upper limb function in postpartum women with De Quervain's tenosynovitis.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
De Quervain's tenosynovitis is a musculoskeletal condition affecting the abductor pollicis longus and extensor pollicis brevis tendons within the first dorsal compartment of the wrist. It is associated with pain, tenderness, restricted thumb and wrist movement, and difficulty performing daily activities. Postpartum women may be particularly affected because of repetitive wrist and thumb movements associated with infant care.
Extracorporeal shock wave therapy (ESWT) is a non-invasive treatment modality being investigated for its potential effects on pain reduction and functional recovery in musculoskeletal disorders.
This study is designed as a prospective randomized controlled trial involving 40 postpartum women diagnosed with De Quervain's tenosynovitis. Participants will be randomly allocated into two equal groups of 20 women each.
The study group will receive extracorporeal shock wave therapy combined with a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises.
The control group will receive the same therapeutic exercise program without shock wave therapy.
Outcome assessments will be conducted before and after the treatment period. Pain intensity will be evaluated using the Visual Analogue Scale (VAS), wrist and thumb range of motion will be measured using a goniometer, and upper limb function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
The study will compare changes within and between the two groups to evaluate the additional effect of shock wave therapy on pain, range of motion, and upper limb function in postpartum women with De Quervain's tenosynovitis.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Mai Kamel Anwar, B.Sc
- Número de teléfono: 01001813906
- Correo electrónico: Maikamel905@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Elham Shahat Hassan, PhD
Ubicaciones de estudio
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Giza, Egipto
- Kasr El Ainy University Hospital
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Contacto:
- Mai Kamel Anwar, B.Sc
- Número de teléfono: 01001813906
- Correo electrónico: Maikamel905@gmail.com
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Women in the postpartum period of > 6 months following labor
- Age: Between 25 and 35 years old.
- Body mass index: Between 25-30 kg / m2
- Diagnosis: Clinically diagnosed with De Quervain tenosynovitis by an orthopedic specialist or confirmed through clinical evaluation.
- Pain Severity: Presenting with moderate to severe pain (≥ 4 on the Visual Analogue Scale).
- Obstetric History: Multipara women (Cesarean section or normal labor)
- Stage of Condition Chronic stage: symptoms > 6 weeks
Exclusion Criteria:
- Previous Surgery: History of surgical intervention on the affected wrist or thumb.
- Skin Conditions: Open wounds, infections, or dermatological diseases at the application site that may interfere with shockwave therapy.
- Pregnancy: Pregnant or lactating women.
- Medication Use: Currently taking systemic corticosteroids, anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs) that may influence study outcomes.
- Pacemaker or Metal Implants: Presence of a cardiac pacemaker or metal implants near the treatment area.
- Other Physiotherapy: Receiving concurrent physiotherapy treatment for the same condition during the study period.
- Non-compliance: Inability or unwillingness to attend treatment sessions or follow instructions throughout the study duration.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Shock Wave Therapy + Therapeutic Exercises
Twenty postpartum women with De Quervain's tenosynovitis will receive extracorporeal shock wave therapy (ESWT) in addition to a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises. The exercise program will be performed for 30 minutes daily over four weeks. |
Extracorporeal shock wave therapy will be applied to the affected first dorsal compartment of the wrist using a radial shock wave device. Treatment parameters will include 1,000 impulses per session, with frequencies ranging from 18 to 21 Hz and pressure settings ranging from 1.4 to 1.8 bar, according to the study protocol.
Otros nombres:
A structured therapeutic exercise program consisting of tendon gliding, stretching, active range-of-motion exercises, and progressive strengthening exercises targeting the wrist and thumb. Exercises will be performed for 30 minutes daily over four weeks, according to participants' tolerance. |
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Comparador activo: Therapeutic Exercises
Twenty postpartum women with De Quervain's tenosynovitis will receive a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises for 30 minutes daily over four weeks, without shock wave therapy. |
A structured therapeutic exercise program consisting of tendon gliding, stretching, active range-of-motion exercises, and progressive strengthening exercises targeting the wrist and thumb. Exercises will be performed for 30 minutes daily over four weeks, according to participants' tolerance. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Intensity Measured by Visual Analogue Scale (VAS)
Periodo de tiempo: 4 weeks
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Pain intensity will be measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain. Changes in pain intensity will be compared between the study and control groups. |
4 weeks
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Wrist Flexion Range of Motion
Periodo de tiempo: 4 weeks
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Change in active wrist flexion range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Wrist Extension Range of Motion
Periodo de tiempo: 4 weeks
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Change in active wrist extension range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Wrist Radial Deviation Range of Motion
Periodo de tiempo: 4 weeks
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Change in active wrist radial deviation range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Wrist Ulnar Deviation Range of Motion
Periodo de tiempo: 4 weeks
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Change in active wrist ulnar deviation range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Thumb Flexion Range of Motion
Periodo de tiempo: 4 weeks
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Change in active thumb flexion range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Thumb Extension Range of Motion
Periodo de tiempo: 4 weeks
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Change in active thumb extension range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Thumb Abduction Range of Motion
Periodo de tiempo: 4 weeks
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Change in active thumb abduction range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Thumb Adduction Range of Motion
Periodo de tiempo: 4 weeks
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Change in active thumb adduction range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Upper Limb Disability Measured by DASH Questionnaire
Periodo de tiempo: 4 weeks
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Upper limb function and disability will be assessed using the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The total score ranges from 0 (no disability) to 100 (maximum disability). Lower scores indicate better upper limb function. |
4 weeks
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Silla de estudio: Hala Mohamed Hanafy, PhD, Professor, Cairo University
- Director de estudio: Sameh Hussien Samir, PhD, Professor, National Research Centre
- Director de estudio: Elham Shahat Hassan, PhD, Ass. Professor, Cairo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Enfermedades Musculares
- Tendinopatía
- Atrapamiento del tendón
- Enfermedad de De Quervain
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Terapia ultrasónica
- Diatermia
- Hipertermia, inducida
- Terapia de ondas de choque extracorpóeos
- Terapia de ejercicio
Otros números de identificación del estudio
Otros números de identificación del estudio
- P.T.REC/012/006319
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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