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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Occupational intervention
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occupational intervention<br>Early coordinated occupational intervention. Supervision in physically activities by a physiotherapist. | Behavioral: Occupational intervention<br>* Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.<br>|
| Active Comparator: Usual care<br>Intervention from the patient's general physician. | Other: Usual care<br>* Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulated duration of self-assessed sick leave due to LBP |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain level | 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). | 6 months | 
| Changes in Fear Avoidance Beliefs scores | Both Fear Avoidance Beliefs Work Subscale and Physical Activity subscale (questionnaires) will be measured. | 6 months | 
| Change in Disability | The 24-item Roland Morris Disability Questionnaire will measure participant-rated LBP disability. | 6 months | 
| Satisfaction with the intervention | Measured on an 11-point NRS with the anchors not at all satisfied to extremely satisfied. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Return to work, Sickness absence, Rehabilitation, Occupational intervention