- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07714031
Comparative Effects of 3-Dimensional Articular and Soft Tissue Myofascial Release Approach in Patients With Overuse Syndrome of Wrist Joint
Overuse syndrome or RSI is challenging condition among clinicians now a days. These are MSK disorders which are related to bones, muscles and tendons peripheral nerve entrapment and vascular changes. These MSK disorders commonly effects back, neck and upper limbs although it least effect lower limbs. These problems occur from repetitive movements, ergonomic hazards, awkward postures and work related problems. This study aims to assess the comparative effects of 3 dimensional articular myofascial release approach and soft tissue myofascial release approach in patients with overuse syndrome of wrist joint. A randomized controlled trial will be conducted age between 20-55 years, both male and female genders will be included diagnosed with overuse syndrome of wrist. Diagnosis will be made on the basis of diagnostic criteria which will include tenderness present in intrinsic muscles and pain in radial ligament of wrist. Participants will be chosen through consecutive sampling.
Each participant will sign a consent form before taking part in the study. According to sample size 46 participants will be divided into two groups. Each group will include 23 participants which will be divided through lottery method. Both groups will receive baseline treatment which will include hot-pack for 15 minutes. Group a will be treated with articular fascial release and group b will be treated with soft tissue release for 3 sessions per week, for 3 weeks. After therapy session both groups will perform wrist rom exercises including wrist flexion, extension, radial and ulnar deviation 5 repetitions each. Outcome measuring tools will be numeric pain rating scale (NPRS) for pain, disabilities of arm, shoulder and hand (DASH) for functional disability, patient rated wrist evaluation (PRWE) specifically wrist functions evaluation and goniometer for range of motion. Data will be investigated through SPSS.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr Rubina Zulfqar
- Número de teléfono: +923414291664
- Correo electrónico: drrubinazulfqar355@gmail.com
Ubicaciones de estudio
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Punjab Province
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Faisalabad, Punjab Province, Pakistán, 38000
- Reclutamiento
- Dr Rubina Zulfqar
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Contacto:
- Dr Rubina Zulfqar
- Número de teléfono: +923414291664
- Correo electrónico: drrubinazulfqar355@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Patients between 20-55 years of age
- Male and female
- Participants involved in repetitive movements of hands e.g computer workers ( 2026/3/4
- Patients who have gradual onset of pain not sudden
- Reproduction of pain with wrist flexion, extension, ulnar and radial deviation
- Patients with >10% reduced ROM of wrist joint as compared to contralateral side
- Participants who will willing to participate
Exclusion Criteria:
Specific disease of wrist e.g RA, gout, infection
- Patients with traumatic wrist pathology (such as scaphoid fracture, distal radius fracture)
- Neuropathic compromise patients such as diabetic neuropathy, CTS
- Open wound
- Suspected or confirmed malignancy in wrist joint
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 |
|---|---|
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Experimental: 3- dimensional Articular fascial release approach
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Hot pack for 15 mins.3-
dimensional Articular fascial release approach
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Experimental: 3 Dimensional soft tissue release approach
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Hot pack for 15 mins. 3 Dimensional soft tissue release approach
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Intensity
Periodo de tiempo: 3 weeks
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Pain Intensity will be measured by using the Numeric Pain Rating Scale, the patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).NPRS scale consists of 11 points in which 0 is no pain while 10 is worst pain.
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3 weeks
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Range of Motion
Periodo de tiempo: 3 weeks
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Range of Motion will be measured by using Goniometry the improvement in ROM shows good results.
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3 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional disability
Periodo de tiempo: 3 weeks
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Functional disability will be measured by using The Disabilities of Arm, Shoulder and Hand (DASH) and Patient-rated wrist evaluation form (PRWE).
The DASH questionnaire is consists of thirty items which asses the physical function and symptoms.
It involve five options for response of each item.
Ultimate score is calculated through the formula below: DASH score = {(sum of n responses)-1}*25, n=number of complete responses, the highest score showed improvement.
While The PRWE is a self administrated questionnaire which is patient specific which consist of 15 items.
It was designed for measurement of activities of daily living of wrist pain and disability and consist of 2 subscales; pain and function.A score of 100 represent the worst functional score while the score 0 indicate no disability.
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3 weeks
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Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- TUF/EIRB/177/26
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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