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

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Occupational intervention; Other: Usual care

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 Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg
    • Copenhagen, Frederiksberg, Denmark, 2000 F
      • The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accumulated duration of self-assessed sick leave due to LBP		12 months
MRI findings	Degree of degenerative MRI findings in the lumbar spine predicts outcome (sick leave)	Baseline
Predictors of outcome	Baseline questionnaires scores (Pain categorization (PainDETECT®), Numeric Pain Rating Scale (NPRS), Fear Avoidance Beliefs, 36-item short-form health-survey (SF36) and Roland Morris Disability) are associated with outcome (sick leave).	Baseline

Collaborators and Investigators

• Sponsor: Frederiksberg University Hospital
• Collaborators: Bispebjerg Hospital
• Investigators: Principal Investigator: Ann Kryger, MD, PhD, University Hospital Frederiksberg and Bispebjerg

Publications and helpful links

General Publications

• 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.

Helpful Links

• The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 29, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: February 10, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Low back pain; Return to work; Sickness absence; Occupational intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: GoBack-001