- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06814821
Rehabilitación basada en la web después de procedimientos de rescate quirúrgico para la osteoartritis de muñeca
Web-based Rehabilitation After Surgical Salvage Procedures for Wrist Osteoarthritis: A Randomized Controlled Trial
Wrist osteoarthritis is often caused by past trauma to the wrist. The primary symptom is joint pain. Salvage surgery is the final solution if exercise therapy, analgesics, orthoses, or cortisone injections fail to relieve pain.
This trial aims to evaluate if a web-based rehabilitation protocol is non-inferior to standard, face-to-face, rehabilitation in terms of patient-reported outcome after surgical salvage procedures.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Osteoarthritis (OA) is a chronic disease which affects all tissues of the joint - cartilage, ligaments, synovial membrane, tendons, and bone. The primary symptom is joint pain but other symptoms like swelling, stiffness, crepitus, and joint instability may also be present.
OA is most in common in knee, hip, and hand but all joints can be affected. It is estimated that nearly 50% of women and 25% of men risk hand OA during their lifetime. Interphalangeal joints and thumb base are the primarily affected joints in the hand while the wrist is less common. Wrist OA is, in contrary to interphalangeal joints and thumb base, more common in men than in women and at a younger age.
Wrist OA is often caused by past trauma to the wrist e.g., fractures, dislocations, and ligament injuries. However, avascular necrosis i.e., Mb Kienböck and Mb Preiser, and other medical conditions may also lead to wrist OA.
Although there is no cure, patients with hip and knee OA, may benefit from self-management treatment options. For hand and wrist OA, the effects of exercise therapy are less studied. A Cochrane review found low-quality evidence of small positive effects of exercise on pain, function, and finger joint stiffness. In wrist OA, a recent randomized controlled trial reported that neuromuscular joint-protective exercise therapy was not superior to range of motion exercises in reducing pain and improving function.
Salvage surgery is the final solution if exercise therapy, analgesics, orthoses, or cortisone injections fail to relieve pain. Numerous studies describe different types of surgical salvage procedures in wrist OA but, to our knowledge, none compare different types of rehabilitation after surgery.
Telerehabilitation for acute and chronic musculoskeletal disorders including OA have been used for over a decade, with an increased demand during the Covid 19 pandemic, and continue to evolve. Telerehabilitation is defined as the "Delivery of therapeutic rehabilitation at a distance or offsite using telecommunication technologies" and includes a wide variety of interventions such as assessments, education, or exercises via mobile or tablet applications, web pages and so forth.
Systematic reviews have shown telerehabilitation to be equal to or superior to standard rehabilitation in various musculoskeletal conditions but without a high level of evidence. Few previous studies focus on disorders of the hand and wrist. In conservatively treated hand OA, operated carpal tunnel syndrome, and operatively and nonoperatively treated patients with bony or soft tissue conditions of the hand and wrist, mobile applications were better than home exercise programs on paper in improving upper limb function and decreasing the number of clinical appointments and referral for rehabilitation.
Telerehabilitation after OA surgery has shown good results in both patient satisfaction and clinical outcomes, but previous studies have mainly focused on hip and knee OA. Although a steadily increasing number of studies, investigators have not been able to find any studies comparing web-based or telerehabilitation to standard, face-to-face, rehabilitation after surgical salvage procedures for wrist OA.
Research question:
Is a web-based rehabilitation protocol non-inferior to standard, face-to-face, rehabilitation in terms of patient-reported outcome after surgical salvage procedures for wrist osteoarthritis?
Hypothesis:
A postoperative web-based rehabilitation protocol is non-inferior to standard rehabilitation in terms of patient-reported outcome measured by Patient Reported Wrist Evaluation (PRWE) 3 months after cast removal in patients operated with surgical salvage procedures for wrist osteoarthritis.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tobias Tandrup, MSc, PhD student
- Número de teléfono: +46812364394
- Correo electrónico: tobias.tandrup@ki.se
Copia de seguridad de contactos de estudio
- Nombre: Elin M Swärd, PhD
- Correo electrónico: elin.sward@regionstockholm.se
Ubicaciones de estudio
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Stockholm, Suecia, 11883
- Reclutamiento
- Department of hand handsurgery, Södersjukhuset
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Contacto:
- Tobias M Tandrup
- Número de teléfono: +4681236000
- Correo electrónico: tobias.tandrup@regionstockholm.se
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Contacto:
- Elin M Swärd, MD. PhD
- Número de teléfono: +4681236000
- Correo electrónico: elin.sward@regionstockholm.se
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Planned surgery:
- Four corner fusion (4CF)
- Lunate-Capitate fusion (LCF)
- Scaphoid-Trapezium-Trapezoid fusion (STT)
- Radius-Scaphoid-Lunate fusion (RSL)
- Proximal Row Carpectomy (PRC)
- Access to digital identification.
Exclusion Criteria:
- Unstable rheumatoid arthritis or other chronic inflammatory arthritis. However, stable inflammatory arthritis with unchanged medication during the last 12 weeks is not an exclusion criteria.
- History of psoriasis arthritis, gout, or pseudogout affecting the hand or wrist.
- Symptomatic OA in nearby joints.
- Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction, inability to use web-based tools).
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: Web-based rehabilitation
The web-based platform contains text, images, and videos which will educate and inform the patient regarding the operation and rehabilitation. There will be no scheduled physical consultations, however participants may request additional video consultations and can send text messages to the hand therapist. |
Participants perform their rehabilitation independently with the instructions from the web-based platform. |
|
Comparador activo: Standard rehabilitation
The control group receive the same education and exercises. The information is provided verbally and a booklet with images of the exercises is given. However, they do not get access to the web-based platform and follow-up appointments are face-to-face at the clinic. At the follow-up appointments, participants perform their exercises, and adjustments and corrections are made when needed. |
Participants attend physical visits at the clinic to get instructions and support in their rehabilitation. Written and verbal instructions will be given. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient Rated Wrist Evaluation (PRWE) score, 3 months after cast removal compared to baseline.
Periodo de tiempo: From enrollment to the end of treatment at 3 months after cast removal.
|
Patient Rated Wrist Evaluation (PRWE) score (0-100 points). A higher score indicates a worse outcome. |
From enrollment to the end of treatment at 3 months after cast removal.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain at rest and on load - change in score from baseline to cast removal and 3 months after cast removal.
Periodo de tiempo: From enrollment to the end of treatment at 3 months after cast removal.
|
Pain Numerical Rating Scale (PNRS). A higher score indicates a worse outcome. |
From enrollment to the end of treatment at 3 months after cast removal.
|
|
Quality of life (EQ-5D-5L) - change in score from baseline to cast removal and 3 months after cast removal.
Periodo de tiempo: From enrollment to the end of treatment at 3 months after cast removal.
|
EQ-5D-5L (0-1 points). A lower score indicates a worse outcome. |
From enrollment to the end of treatment at 3 months after cast removal.
|
|
Tampa Scale of Kinesiophobia - change in score from baseline to cast removal and 3 months after cast removal.
Periodo de tiempo: From enrollment to the end of treatment at 3 months after cast removal.
|
Tampa Scale of Kinesiophobia (TSK-17) (17-68 points). A higher score indicates a worse outcome. |
From enrollment to the end of treatment at 3 months after cast removal.
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|
Range of motion - change from baseline to cast removal and 3 months after cast removal.
Periodo de tiempo: From enrollment to the end of treatment at 3 months after cast removal.
|
Range of motion (ROM) of the wrist (extension/flexion, radial/ulnar deviation, pronation/supination). |
From enrollment to the end of treatment at 3 months after cast removal.
|
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Grip strength - change in score from baseline to 3 months after cast removal.
Periodo de tiempo: From enrollment to the end of treatment at 3 months after cast removal.
|
Grip strength (hydraulic hand dynamometer) |
From enrollment to the end of treatment at 3 months after cast removal.
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Patient Reported Experience Measures (PREM).
Periodo de tiempo: 3 months after cast removal.
|
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3 months after cast removal.
|
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Adherence to excercise program.
Periodo de tiempo: From enrollment to the end of treatment at 3 months after cast removal.
|
Adherence, using an exercise diary. |
From enrollment to the end of treatment at 3 months after cast removal.
|
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Differences in direct costs - between groups.
Periodo de tiempo: From enrollment to the end of treatment at 3 months after cast removal.
|
Differences in costs of rehabilitation, defined as hand therapist-delivered contacts, including face-to-face, telephone, and video consultations. |
From enrollment to the end of treatment at 3 months after cast removal.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elin M Swärd, PhD, KI Department of Clinical Science and Education, Södersjukhuset
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Web-based rehab - wrist OA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Access to de-identified study data may be granted to qualified researchers upon reasonable request and subject to approval by the Swedish Ethical Review Authority. Requests should be directed to the corresponding author.
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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