Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack) (GoBack)
Low back pain (LBP) is a recognized public health problem with high life time prevalence. Medical treatment may reduce the physical and mental discomfort, while it has not been able to improve the possibilities for retaining or return patients with LBP to work.
This is an occupational intervention study for patients with LBP and physically demanding work, who are at risk of drop out of labour; a randomized controlled trial designed to test the effectiveness of an early intervention for retaining subjects with LBP attached to the labour marked. A work place modification intervention combined with moderate physical activity is given in the intervention group additional to LBP treatments according to best practice recommendations for general practice.
The study population consists of patients in self-reported physically demanding, who are sick listed or at risk of sick leave due to LBP. Outcome will continually be collected during the intervention as well as 6 and additionally at 12 months follow up.
The primary aim is to evaluate if an occupational intervention with focus on early workplace orientated counselling and work place intervention can retain subjects with physically demanding work and LBP in gainful employment to prevent/reduce the sick leave due to LBP.
The secondary aims are to identify prognostic factors of an occupational intervention using the baseline and follow-up participant-rated outcomes: pain, physically function, generic health status, fear avoidance behaviours, job satisfaction, work-ability, satisfaction with intervention, clinical examination and MRI findings. Among these variables, we also aim to identify subjects, who will benefit from such an occupational intervention, and the subjects, who already have a good prognosis and therefore have no need for a larger scale intervention.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Eligible participants are: 1) 18-65 years of age; 2) current episode of 2-4 weeks of LBP; 3) self-reported physically demanding work; 4) express concerns about the ability to maintain their current job.
The exclusion criteria are: 1) pregnancy; 2) server somatic or psychiatric diseases; 3) cancer or metastatic disease
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Frederiksberg
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Copenhagen, Frederiksberg, Dinamarca, 2000 F
- The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital
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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:
- Working age adults 18-65
- Low back pain (current episode of 2-4 weeks)
- Self-reported physically demanding work
- Sick-listed or at risk
- Speak, read and understand Danish
- Accept workplace visit by the occupational physicians
- Be in gainful employment for at last 30 hours/week
Exclusion Criteria:
- Severe somatic or psychiatric comorbidity
- Pregnancy
- Cancer or metastatic disease
- LBP treatment or referral to outside providers (e.g. back-surgery)
- Contraindications for having a MRI.
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 |
|---|---|
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Experimental: Occupational intervention
Early coordinated occupational intervention.
Supervision in physically activities by a physiotherapist.
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Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.
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Comparador activo: Usual care
Intervention from the patient's general physician.
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Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Accumulated duration of self-assessed sick leave due to LBP
Periodo de tiempo: 6 months
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in pain level
Periodo de tiempo: 6 months
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Pain will be evaluated by using the 13 items Pain-Detect questionnaire, which includes measurements of LBP on an ordinal, 11-point numerical rating scale (NRS: 0 = no LBP; 10 = worst LBP possible).
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6 months
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Changes in Fear Avoidance Beliefs scores
Periodo de tiempo: 6 months
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Both Fear Avoidance Beliefs Work Subscale and Physical Activity subscale (questionnaires) will be measured.
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6 months
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Change in Disability
Periodo de tiempo: 6 months
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The 24-item Roland Morris Disability Questionnaire will measure participant-rated LBP disability.
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6 months
|
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Satisfaction with the intervention
Periodo de tiempo: 6 months
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Measured on an 11-point NRS with the anchors "not at all satisfied" to "extremely satisfied".
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6 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Accumulated duration of self-assessed sick leave due to LBP
Periodo de tiempo: 12 months
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12 months
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MRI findings
Periodo de tiempo: Baseline
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Degree of degenerative MRI findings in the lumbar spine predicts outcome (sick leave)
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Baseline
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Predictors of outcome
Periodo de tiempo: Baseline
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Baseline questionnaires scores (Pain categorization (PainDETECT®), Numeric Pain Rating Scale (NPRS), Fear Avoidance Beliefs, 36-item short-form health-survey (SF36) and Roland Morris Disability) are associated with outcome (sick leave).
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Baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ann Kryger, MD, PhD, University Hospital Frederiksberg and Bispebjerg
Publicaciones y enlaces útiles
Publicaciones Generales
- Jensen C, Jensen OK, Nielsen CV. Sustainability of return to work in sick-listed employees with low-back pain. Two-year follow-up in a randomized clinical trial comparing multidisciplinary and brief intervention. BMC Musculoskelet Disord. 2012 Aug 25;13:156. doi: 10.1186/1471-2474-13-156.
- Rosenberg NR, Petersen SB, Begtrup LM, Flachs EM, Petersen JA, Hansen BB, Kirkeskov L, Bliddal H, Christensen R, Kristensen LE, Fournier GL, Kryger AI. Early Occupational Intervention for People with Low Back Pain in Physically Demanding Jobs: 1-year Follow-up Results of the Randomized Controlled GOBACK Trial. Spine (Phila Pa 1976). 2021 Mar 15;46(6):347-355. doi: 10.1097/BRS.0000000000003793.
- Hansen BB, Kirkeskov L, Begtrup LM, Boesen M, Bliddal H, Christensen R, Andreasen DL, Kristensen LE, Flachs EM, Kryger AI. Early occupational intervention for people with low back pain in physically demanding jobs: A randomized clinical trial. PLoS Med. 2019 Aug 16;16(8):e1002898. doi: 10.1371/journal.pmed.1002898. eCollection 2019 Aug.
- Petersen J, Kirkeskov L, Hansen BB, Begtrup LM, Flachs EM, Boesen M, Hansen P, Bliddal H, Kryger AI. Physical demand at work and sick leave due to low back pain: a cross-sectional study. BMJ Open. 2019 May 22;9(5):e026917. doi: 10.1136/bmjopen-2018-026917.
- Hansen BB, Kirkeskov L, Christensen R, Begtrup LM, Pedersen EB, Teilya JF, Boesen M, Fournier GL, Bliddal H, Kryger AI. Retention in physically demanding jobs of individuals with low back pain: study protocol for a randomised controlled trial. Trials. 2015 Apr 16;16:166. doi: 10.1186/s13063-015-0684-3.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
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
- GoBack-001
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