NCT02015572

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
302

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

November 29, 2013

Last Update Submit

February 10, 2017

Conditions

Low Back Pain

Keywords

Low back painReturn to workSickness absenceRehabilitationOccupational intervention

Outcome Measures

Primary Outcomes (1)

  • Accumulated duration of self-assessed sick leave due to LBP

    6 months

Secondary Outcomes (4)

  • Changes in pain level

    6 months

  • Changes in Fear Avoidance Beliefs scores

    6 months

  • Change in Disability

    6 months

  • Satisfaction with the intervention

    6 months

Other Outcomes (3)

  • Accumulated duration of self-assessed sick leave due to LBP

    12 months

  • MRI findings

    Baseline

  • Predictors of outcome

    Baseline

Study Arms (2)

Occupational intervention

EXPERIMENTAL

Early coordinated occupational intervention. Supervision in physically activities by a physiotherapist.

Behavioral: Occupational intervention

Usual care

ACTIVE COMPARATOR

Intervention from the patient's general physician.

Other: Usual care

Interventions

Occupational interventionBEHAVIORAL

Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.

Occupational intervention
Usual careOTHER

Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician

Usual care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, Frederiksberg, 2000 F, Denmark

Location

Related Publications (5)

  • 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.

    PMID: 22920158BACKGROUND

  • 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.

    PMID: 33181779DERIVED

  • 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.

    PMID: 31419219DERIVED

  • 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.

    PMID: 31122982DERIVED

  • 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.

    PMID: 25887302DERIVED

Related Links

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ann Kryger, MD, PhD

    University Hospital Frederiksberg and Bispebjerg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 29, 2013

First Posted

December 19, 2013

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

December 1, 2018

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations

DK(1)