Development of a Pain Rehabilitation Program for Chronic Pain After SCI
Feasibility of a New Digital Pain Rehabilitation Program for People With SCI
Pain rehabilitation programs are essential for optimal treatment of chronic pain and are usually based on the biopsychosocial model. This is, however, not standard care for people with chronic pain after a spinal cord injury (SCI) due to a biomedical focused perspective of SCI and lack of adapted programs.
The aims of this feasibility study:
- Develop a new digital pain rehabilitation program, adapted for the needs of people living with an SCI.
- To investigate the feasibility and acceptability of a new digital pain rehabilitation program.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study follows the guidelines of Medical Research Council for complex interventions and the proposed iterative feasibility process to improve and prepare the intervention for future testing in an RCT study. The research group will, toghether with a reference groups, develop a digital intervention porposal. The program will be a team-based, goal-oriented program for patients with spinal cord injury (SCI) and chronic pain.
In this study, eligible participants are included in an 8 week pain rehabilitation program. The program is developed through user-involvement i.e. together with clinicians (experienced in pain rehabilitation and/or SCI rehabilitation), stakeholders, researchers and individuals with SCI. The program will include video material for education, home exercises and group discussions led by clinicians with long experience in pain rehabilitation and SCI.
The participants will fill in self-assessed questionaries at baseline and after the finish of the program about their pain, sleep, mood and quality of life. After the program some of the participants will be asked to participate in semi-structured interviews about how they navigate and engage with different components of the program. The patients will be recruited during a rutine follow up at an SCI clinic.
Seven factors will be studied to assess the feasibility and acceptability of the program, based on set goals according to the Traffic Light method.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gunilla Stenberg, Docent
- Número de teléfono: +46 90 7869895
- Correo electrónico: gunilla.stenberg@umu.se
Copia de seguridad de contactos de estudio
- Nombre: Sofia Björkbacka, MSc
- Número de teléfono: 0046907869349
- Correo electrónico: sofia.bjorkbacka@umu.se
Ubicaciones de estudio
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Umeå, Suecia, 90736
- Inst. Community Medicine and Rehabilitation
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- two years since injury
- Stable pain medication?
Exclusion Criteria:
- severe cognitive impairment
- Alcohol or drug abuse
- does not understand Swedish
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Spinal cord injury (SCI) and chronic pain
People with chronic pain after spinal cord injury
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8- week pain rehabilitation program.
The first meeting of the program is located at a hospital facility and thereafter they will meet at a digital platform.The program include education, home exercises and group meetings.
The program consists of 4 modules.
1. Physical exercise and ergonomics.
2. Structure and recovery.
3. Employment/occupation and social support.
4. ACT and coping.
Each module lasts for two weeks.
The program will include video material for education, home exercises and group discussions led by clinicians with long experience in pain rehabilitation and SCI.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Recruitment rate, number recruited per quarter
Periodo de tiempo: At enrollment
|
Continue=6 Solve=4 Stop=3
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At enrollment
|
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Number of participant with treatment-related advere events as assessed by...
Periodo de tiempo: From enrollment to the end of tretment at 8 weeks
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From enrollment to the end of tretment at 8 weeks
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Participant retention- Completion rates
Periodo de tiempo: The end of the 8- week program
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>75% continue, 50-75% Solve, <50% stop
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The end of the 8- week program
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Program Adherence
Periodo de tiempo: The end of the 8-week program
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Continue >75%, solve 50-75%, stop <50%
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The end of the 8-week program
|
|
Patients' self-perceived relevance, timing and mode of delivery
Periodo de tiempo: >70% Continue, Solve 50-70%, Stop <50%
|
Patient evaluation, satisfied patients
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>70% Continue, Solve 50-70%, Stop <50%
|
|
Assessment procedure acceptance- Patient evaluations, proportions of completed questionnaires
Periodo de tiempo: At the end of the 8-week program
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>80% continue, 50-80% solve, <50% stop
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At the end of the 8-week program
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Fidelity of delivery - Process evaluations
Periodo de tiempo: End of the 8-week program
|
End of the 8-week program
|
Colaboradores e Investigadores
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
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Manifestaciones neuroconductuales
- Trauma, Sistema Nervioso
- Enfermedades de la médula espinal
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor crónico
- Neuralgia
- Lesiones de la médula espinal
- Agnosia
Otros números de identificación del estudio
- 2023-04232-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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