- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02417402
Efficacy of Educating Physical Therapists in the Treatment of Patients With Nonspecific Chronic Low Back Pain
Efficacy of Educating Physical Therapists on Clinical Practice Guidelines and Pain Management in the Treatment of Patients With Nonspecific Chronic Low Back Pain: a Cluster Randomized Controlled Trial
Descripción general del estudio
Descripción detallada
The training "Update on the treatment of patients with nonspecific chronic low back pain" will be announced in the social network by members of the study. Interested physical therapists will send an email to one of the study authors with their information regarding the inclusion criteria. After two months of notice, interested and eligible physiotherapists will be randomized into two groups of 15 participants each.
The study arms are: 1) control group (physical therapist who will not receive training) and 2) experimental group (physical therapist who will receive training). Before and after training, attitudes, beliefs and knowledge about low back pain guidelines will be evaluated.
Each physical therapist will recruit for the study a total of fifteen consecutive patients with chronic nonspecific low back pain (total sample=150 patients). All the patients will be assessed before the first session by a blinded examiner who will be unaware about the group allocation.
Clinical outcomes (pain, disability, fear avoidance beliefs and pain catastrophizing) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.
Tipo de estudio
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 seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 pain numerical rating scale, aged between 18 and 65 years.
- physiotherapists who treat exclusively patients with musculoskeletal pain, duly accredited by the National Council of Physical Therapy, physiotherapists offering private or medical insurance treatment individually to their patients, lasting 50-60 minutes each session, physiotherapists from 2 to five years of graduation and / or working in the area for the same period, that treat at least 2 patients with low back pain per month, and who are willing to treat at least 10 patients for the study.
Exclusion Criteria:
- patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy.
- physiotherapists who want to stop the activities for some reason that prevents participation in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Untrained Physical Therapists
The patients allocated to the Control group will be treated by physical therapists who did not receive any training about clinical practice guidelines and pain management.
These patients will receive the usual care from their physical therapists.
|
The patients allocated to the Control group will be treated by physical therapists who did not carry out the training before treatment.
The physical therapists will use their usual care for nonspecific chronic low back pain.
Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).
Each treatment session has an estimated duration of 50-60 minutes.
Otros nombres:
|
Experimental: Trained Physical Therapists
The patients allocated to the Experimental group will be treated by physical therapists who received training about clinical practice guidelines and pain management.
|
The patients allocated to the Experimental group will be treated by physical therapists who carried out the training before treatment.
The training will be designed to guide the physical therapists beliefs and attitudes to a biopsychosocial model; update knowledge contained in clinical practice guidelines; and enable physical therapists to identify, integrate and address psychosocial factors in patients with nonspecific chronic low back pain.
Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).
Each treatment session has an estimated duration of 50-60 minutes.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain intensity (Pain NRS)
Periodo de tiempo: 5 weeks after randomization
|
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
|
5 weeks after randomization
|
Disability (24-item Roland Morris Disability Questionnaire)
Periodo de tiempo: 5 weeks after randomization
|
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
|
5 weeks after randomization
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain intensity (Pain NRS)
Periodo de tiempo: 3 and 6 months after randomization
|
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
|
3 and 6 months after randomization
|
Disability ( 24-item Roland Morris Disability Questionnaire)
Periodo de tiempo: 3 and 6 months after randomization
|
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
|
3 and 6 months after randomization
|
Fear Avoidance Beliefs (FABQ)
Periodo de tiempo: 5 weeks, 3 months and 6 months after randomization
|
Fear avoidance belief will be measured by the 16-item Fear Avoidance Belief Questionnaire (FABQ)
|
5 weeks, 3 months and 6 months after randomization
|
Pain Catastrophizing (PCS)
Periodo de tiempo: 5 weeks, 3 months and 6 months after randomization
|
Pain Catastrophizing will be measured by the 13-item Pain Catastrophizing Scale (PCS)
|
5 weeks, 3 months and 6 months after randomization
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain attitudes and beliefs for physiotherapists (PABS.PT)
Periodo de tiempo: Baseline and 5 weeks after randomization
|
Pain Attitudes and Beliefs will be measured by the 19-item Pain Attitudes and Beliefs Scale for Physiotherapists (PABS.PT)
|
Baseline and 5 weeks after randomization
|
Adherence to guidelines for physiotherapists (0-100% Low Back Pain Vignettes)
Periodo de tiempo: Baseline and 5 weeks after randomization
|
Adherence to guidelines for physiotherapist will be measured by the 0-100% Low Back Pain Vignettes
|
Baseline and 5 weeks after randomization
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (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
- UNICID032015
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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