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

Not Applicable

• Conditions: Low Back Pain
• Interventions: Other: Usual care; Behavioral: Occupational intervention

• Registration Number: NCT02015572
• Lead Sponsor: Frederiksberg University Hospital

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2013-11-29
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-19
• Study Start: 2016-01
• Primary Completion: 2016-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-13
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 302

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Intervention from the patient's general physician.
Occupational intervention	Occupational intervention	Early coordinated occupational intervention. Supervision in physically activities by a physiotherapist.

Primary Outcome Measures

Name	Time	Method
Accumulated duration of self-assessed sick leave due to LBP	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital; 🇩🇰 Copenhagen, Frederiksberg, Denmark