- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02265172
Physiotherapy Assessment of Patients Referred to Orthopaedic Surgeon
Does Orthopaedic Manual Therapy Assessment of Patients Referred to Orthopaedic Surgeon Bring Any Changes to Referral Routines, Patient Satisfaction and Health-related Variables?
Many patients with musculoskeletal pain in primary healthcare are referred to orthopaedic surgeon, however, a relatively low percentage of these patients are considered suitable for orthopaedic intervention.
Physiotherapists are suitable for musculoskeletal assessments and are used as such in many countries i.e. Advanced Practice Physiotherapists or Extended Scope Physiotherapists, however, this is not an existing model of care in Sweden. To be able to consider this model for implementation in Sweden it is necessary to evaluate it from a healthcare as well as from a patient perspective.
The study is a randomised controlled trial. Overall aim is to evaluate if a orthopaedic manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic surgeon bring any changes to referral routines, patient satisfaction and health-related variables when compared to standard practice.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patients referred for orthopaedic surgeon with sub acute (four weeks to three months) or chronic (>three months) musculoskeletal pain who had the ability to understand written and spoken Swedish.
Exclusion Criteria:
- diagnosed hallux valgus, ganglion or trigger finger.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Physiotherapy screening
Screening consisted of a 60-min appointment including assessment, diagnosis and management. The patients received advice regarding ergonomics, exercises and/or treatment when needed. Management options were;
|
Physiotherapy screening.
|
Comparador activo: Standard practice (orthopaedic surgeon)
Appointment was 15 min, including assessment, diagnosis and management. The patients received advice, prescriptions or injections when needed. Management options were;
|
Orthopaedic surgeon assessment
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number of referrals after consultation as a measure of Management outcome
Periodo de tiempo: 12 months
|
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Scores on the questionnaire Quality from the Patient Perspective as a measure of Patient satisfaction
Periodo de tiempo: 30 days
|
30 days
|
|
Scores on the EuroQol-5D as a measure of Health-related quality of life
Periodo de tiempo: 12 months
|
12 months
|
|
Scores on the Pain Disability Index as a measure of Pain-related disability
Periodo de tiempo: 12 months
|
12 months
|
|
Number of sick-leave days
Periodo de tiempo: 12 months
|
12 months
|
|
Cost per quality adjusted life year (QUALY) gained as a measure of cost-utitily
Periodo de tiempo: 12 months
|
QUALYs are calculated from the EuroQol-5D
|
12 months
|
Scores on the Pain Belief Screening Instrument as a measure of risk for long-term disability
Periodo de tiempo: 12 months
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Maria Larsson, PhD, Närhalsan Research and development, Region of Västra Götaland
Publicaciones y enlaces útiles
Publicaciones Generales
- Samsson K, Larsson ME. Physiotherapy screening of patients referred for orthopaedic consultation in primary healthcare - a randomised controlled trial. Man Ther. 2014 Oct;19(5):386-91. doi: 10.1016/j.math.2013.10.004. Epub 2013 Oct 29.
- Samsson KS, Larsson ME. Physiotherapy triage assessment of patients referred for orthopaedic consultation - Long-term follow-up of health-related quality of life, pain-related disability and sick leave. Man Ther. 2015 Feb;20(1):38-45. doi: 10.1016/j.math.2014.06.009. Epub 2014 Jul 15.
- Samsson KS, Bernhardsson S, Larsson ME. Perceived quality of physiotherapist-led orthopaedic triage compared with standard practice in primary care: a randomised controlled trial. BMC Musculoskelet Disord. 2016 Jun 10;17:257. doi: 10.1186/s12891-016-1112-x.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- EPN GBG 328-09
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