Clinical trial NCT02015572: Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)
Official title: Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Return to work
Sickness absence
Rehabilitation
Occupational intervention
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2013-12-19
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Accumulated duration of self-assessed sick leave due to LBP
timeFrame: 6 months
Secondary outcomes:
measure: Changes in pain level
timeFrame: 6 months
measure: Changes in Fear Avoidance Beliefs scores
timeFrame: 6 months
measure: Change in Disability
timeFrame: 6 months
measure: Satisfaction with the intervention
timeFrame: 6 months
Other outcomes:
measure: Accumulated duration of self-assessed sick leave due to LBP
timeFrame: 12 months
measure: MRI findings
timeFrame: Baseline
measure: Predictors of outcome
timeFrame: Baseline
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital
state: Frederiksberg
Study officials:
affiliation: University Hospital Frederiksberg and Bispebjerg
name: Ann Kryger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.