- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00329342
Return to Work Interventions for Patients With Low Back Pain
Return to Work Interventions for Patients With Low Back Pain During Inpatient Rehabilitation: a Quasi-Experimental Study
Low back pain has become a major concern to employees and employers because of its negative impact on employee health and productivity.
The objective of this study is to investigate whether a return-to-work intervention conducted during inpatient rehabilitation improves functional limitations that are related with low back pain and interfere with job performance.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In recent years most industrialized nations have been confronted with a dramatic increase in cases dealing with back pain; in Germany, back pain belongs to the major individual and societal health problems with associated costs that have put a strain not only on health care systems. Besides frequent demand for medical services, loss of production (due to temporal sick leave) and disability allowances are important economic factors. In total, the estimated annual costs caused by back pain range between 16 and 22 billion Euros. Population based studies revealed high life-time prevalence with 80% report having ever experienced back pain. The point prevalence lies between 30 and 40%. Approximately one-fourth to one-third of those affected suffer from clinically significant back pain. Epidemiological evidence for the prevalence of back pain, its severity, course and associated risk factors is extensive; however, little systematic knowledge is available about treatment of back pain especially about return-to-work interventions.
This study is designed as a quasi-experimental study to evaluate benefits of return-to-work interventions during medical rehabilitation. Positive effects are expected for low back pain related functional limitations and subsequently job performance. The intervention tested is based on the biomechanical model of chronic pain that assumes a relationship between external strain, body posture, muscle activity, and intravertebral pressure. According to this model, chronic low back pain is partially caused by overexertion and poor postural habits. The intervention aims at lowering the impact of biomechanical stress by training an adequate body posture while performing activities of daily living or job-related activities. Additionally, performing job-related activities target fear-avoidance beliefs especially assumptions about the connection between pain and work activities. The experimental group training good postural habits while performing activities of daily living or job-related activities (additionally to standard rehabilitation activities such as physiotherapy or education and counselling) will be compared with participants receiving a standard rehabilitation only.
Outcome measures are assessed at baseline, post-intervention, and 6 month post-intervention.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Bad Elster, Alemania, 08645
- Vogtlandklinik Bad Elster
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Chronic low back pain
- Undergoing inpatient rehabilitation
- Working age
Exclusion Criteria:
- Receiving or applying for retirement pension
- Diagnostic findings that require surgery
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 1
|
Adequate postural habits in activities of daily living
|
|
Sin intervención: 2
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Low Back Pain Disability: Oswestry Disability Index (ODI)
Periodo de tiempo: 6 months
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Return-to-work (RTW) outcomes: Duration of time out of work, RTW-status
Periodo de tiempo: 6 months
|
6 months
|
|
Fear avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) for Patients with Back Pain
Periodo de tiempo: 6 months
|
6 months
|
|
Vitality: SF-36 vitality
Periodo de tiempo: 6 months
|
6 months
|
|
Ergonomic competence: Rating of posture and movement.
Periodo de tiempo: 3 weeks
|
3 weeks
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Martina Markes, Forschungsinstitut fuer Balneologie und Kurortwissenschaft
Publicaciones y enlaces útiles
Publicaciones Generales
- Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
- Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
- Schmidt CO, Kohlmann T. [What do we know about the symptoms of back pain? Epidemiological results on prevalence, incidence, progression and risk factors]. Z Orthop Ihre Grenzgeb. 2005 May-Jun;143(3):292-8. doi: 10.1055/s-2005-836631. German.
- Keller S, Herda C, Ridder K, Basler HD. Readiness to adopt adequate postural habits: an application of the Transtheoretical Model in the context of back pain prevention. Patient Educ Couns. 2001 Feb;42(2):175-84. doi: 10.1016/s0738-3991(00)00103-8.
- Pfingsten M, Kroner-Herwig B, Leibing E, Kronshage U, Hildebrandt J. Validation of the German version of the Fear-Avoidance Beliefs Questionnaire (FABQ). Eur J Pain. 2000;4(3):259-66. doi: 10.1053/eujp.2000.0178.
- Huppe A, Raspe H. [Efficacy of inpatient rehabilitation for chronic back pain in Germany: a systematic review 1980-2001]. Rehabilitation (Stuttg). 2003 Jun;42(3):143-54. doi: 10.1055/s-2003-40099. Erratum In: Rehabilitation (Stuttg). 2003 Oct;42(5):322. German.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
- RTW-LBP-1
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. .
Ensayos clínicos sobre Lumbalgia
-
University Hospital, GrenobleReclutamientoPacientes con EII, tratamiento original, biosimilar, Switch BackFrancia
-
Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)TerminadoEficacia y Tolerancia de B-Back® en el Síndrome de BurnoutFrancia
-
Shanghai Henlius BiotechReclutamientoHER2-LOW Hormonas receptor de cáncer de mama positivoPorcelana
-
Aminex Therapeutics, Inc.ReclutamientoMelanoma (cáncer de piel) | HER2-LOW Hormonas receptor de cáncer de mama positivoEstados Unidos
Ensayos clínicos sobre Occupational ergonomic training
-
Northwestern UniversityReclutamientoApnea obstructiva del sueño (AOS)Estados Unidos
-
Fenerbahce UniversityAcibadem Maslak HospitalAún no reclutandoCáncer pediátrico | Oncología Pediátrica | Catéter venoso central | Colocación de catéter venoso central | Infección del sitio de salida del catéter venoso centralTurquía (Türkiye)
-
Wuerzburg University HospitalReclutamientoPólipo colónico | Adenoma de colonAlemania
-
Ankara Etlik City HospitalReclutamientoOsteoartritis de rodilla | Entrenamiento de equilibrio | Rehabilitación Postoperatoria | Recuperación total de artroplastia de rodillaPavo
-
Rigshospitalet, DenmarkUniversity of CopenhagenTerminadoResultado de aprendizaje | Eficiencia de entrenamientoDinamarca
-
Diala BurjakTerminadoEducación estudiantil | La formación práctica | Educación en línea | Técnicas de sutura | Eficacia del entrenamientoJordán
-
Johns Hopkins Bloomberg School of Public HealthInnovations for Poverty Action; Investors Club/Enterprise UgandaTerminadoEstrés | Bienestar Psicológico | Dificultad económicaUganda
-
University of New HampshireAmerican Heart Association; California State University, San MarcosTerminadoModificación de la dieta | Ejercicio | Presión arterial | Promoción de la salud | Factor de riesgo cardiovascularEstados Unidos
-
Queen's UniversityTerminadoEficacia del Cuaderno de Recuperación como Herramienta Psicoeducativa para Facilitar la RecuperaciónDesordenes mentalesCanadá