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Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)

NCT02015572 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2017-02-13

No results posted yet for this study

Summary

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.

Conditions

  • Low Back Pain

Interventions

BEHAVIORAL

Occupational intervention

Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.

OTHER

Usual care

Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician

Sponsors & Collaborators

  • Bispebjerg Hospital

    collaborator OTHER

  • Frederiksberg University Hospital

    lead OTHER

Principal Investigators

  • Ann Kryger, MD, PhD · University Hospital Frederiksberg and Bispebjerg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-06-30
Completion
2018-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02015572 on ClinicalTrials.gov