Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)
NCT ID: NCT02015572
Last Updated: 2017-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
302 participants
INTERVENTIONAL
2016-01-31
2018-12-31
Brief Summary
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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.
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Detailed Description
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The exclusion criteria are: 1) pregnancy; 2) server somatic or psychiatric diseases; 3) cancer or metastatic disease
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Occupational intervention
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.
Usual care
Intervention from the patient's general physician.
Usual care
Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician
Interventions
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Occupational intervention
Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.
Usual care
Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
* Cancer or metastatic disease
* LBP treatment or referral to outside providers (e.g. back-surgery)
* Contraindications for having a MRI.
18 Years
65 Years
ALL
No
Sponsors
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Bispebjerg Hospital
OTHER
Frederiksberg University Hospital
OTHER
Responsible Party
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Bjarke Brandt Hansen
MD
Principal Investigators
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Ann Kryger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Frederiksberg and Bispebjerg
Locations
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The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital
Copenhagen, Frederiksberg, Denmark
Countries
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References
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Jensen C, Jensen OK, Nielsen CV. Sustainability of return to work in sick-listed employees with low-back pain. Two-year follow-up in a randomized clinical trial comparing multidisciplinary and brief intervention. BMC Musculoskelet Disord. 2012 Aug 25;13:156. doi: 10.1186/1471-2474-13-156.
Rosenberg NR, Petersen SB, Begtrup LM, Flachs EM, Petersen JA, Hansen BB, Kirkeskov L, Bliddal H, Christensen R, Kristensen LE, Fournier GL, Kryger AI. Early Occupational Intervention for People with Low Back Pain in Physically Demanding Jobs: 1-year Follow-up Results of the Randomized Controlled GOBACK Trial. Spine (Phila Pa 1976). 2021 Mar 15;46(6):347-355. doi: 10.1097/BRS.0000000000003793.
Hansen BB, Kirkeskov L, Begtrup LM, Boesen M, Bliddal H, Christensen R, Andreasen DL, Kristensen LE, Flachs EM, Kryger AI. Early occupational intervention for people with low back pain in physically demanding jobs: A randomized clinical trial. PLoS Med. 2019 Aug 16;16(8):e1002898. doi: 10.1371/journal.pmed.1002898. eCollection 2019 Aug.
Petersen J, Kirkeskov L, Hansen BB, Begtrup LM, Flachs EM, Boesen M, Hansen P, Bliddal H, Kryger AI. Physical demand at work and sick leave due to low back pain: a cross-sectional study. BMJ Open. 2019 May 22;9(5):e026917. doi: 10.1136/bmjopen-2018-026917.
Hansen BB, Kirkeskov L, Christensen R, Begtrup LM, Pedersen EB, Teilya JF, Boesen M, Fournier GL, Bliddal H, Kryger AI. Retention in physically demanding jobs of individuals with low back pain: study protocol for a randomised controlled trial. Trials. 2015 Apr 16;16:166. doi: 10.1186/s13063-015-0684-3.
Related Links
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Department of Occupational and Environmental Medicine, Copenhagen University, Hospital Bispebjerg and Frederiksberg
The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital
Other Identifiers
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GoBack-001
Identifier Type: -
Identifier Source: org_study_id
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