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

F

Frederiksberg University Hospital

Status

Unknown

Conditions

Low Back Pain

Treatments

Behavioral: Occupational intervention
Other: Usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT02015572
GoBack-001

Details and patient eligibility

About

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.

Full description

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

Enrollment

302 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

302 participants in 2 patient groups

Occupational intervention
Experimental group
Description:
Early coordinated occupational intervention. Supervision in physically activities by a physiotherapist.
Treatment:
Behavioral: Occupational intervention
Usual care
Active Comparator group
Description:
Intervention from the patient's general physician.
Treatment:
Other: Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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