Overview

This trial is active, not recruiting.

Condition low back pain
Treatments occupational intervention, usual care
Sponsor Frederiksberg University Hospital
Collaborator Bispebjerg Hospital
Start date January 2016
End date September 2016
Trial size 302 participants
Trial identifier NCT02015572, GoBack-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Early coordinated occupational intervention. Supervision in physically activities by a physiotherapist.
occupational intervention
Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.
(Active Comparator)
Intervention from the patient's general physician.
usual care
Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician

Primary Outcomes

Measure
Accumulated duration of self-assessed sick leave due to LBP
time frame: 6 months

Secondary Outcomes

Measure
Changes in pain level
time frame: 6 months
Changes in Fear Avoidance Beliefs scores
time frame: 6 months
Change in Disability
time frame: 6 months
Satisfaction with the intervention
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)
Principal investigator Ann Kryger, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Frederiksberg University Hospital.