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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Occupational intervention
Usual care
Sponsored by
Frederiksberg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Return to work, Sickness absence, Rehabilitation, Occupational intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Occupational intervention

Usual care

Arm Description

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

Intervention from the patient's general physician.

Outcomes

Primary Outcome Measures

Accumulated duration of self-assessed sick leave due to LBP

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2013
Last Updated
February 10, 2017
Sponsor
Frederiksberg University Hospital
Collaborators
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02015572
Brief Title
Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)
Acronym
GoBack
Official Title
Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Frederiksberg University Hospital
Collaborators
Bispebjerg Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Return to work, Sickness absence, Rehabilitation, Occupational intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Occupational intervention
Arm Type
Experimental
Arm Description
Early coordinated occupational intervention. Supervision in physically activities by a physiotherapist.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Intervention from the patient's general physician.
Intervention Type
Behavioral
Intervention Name(s)
Occupational intervention
Intervention Description
Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician
Primary Outcome Measure Information:
Title
Accumulated duration of self-assessed sick leave due to LBP
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in pain level
Description
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).
Time Frame
6 months
Title
Changes in Fear Avoidance Beliefs scores
Description
Both Fear Avoidance Beliefs Work Subscale and Physical Activity subscale (questionnaires) will be measured.
Time Frame
6 months
Title
Change in Disability
Description
The 24-item Roland Morris Disability Questionnaire will measure participant-rated LBP disability.
Time Frame
6 months
Title
Satisfaction with the intervention
Description
Measured on an 11-point NRS with the anchors "not at all satisfied" to "extremely satisfied".
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Accumulated duration of self-assessed sick leave due to LBP
Time Frame
12 months
Title
MRI findings
Description
Degree of degenerative MRI findings in the lumbar spine predicts outcome (sick leave)
Time Frame
Baseline
Title
Predictors of outcome
Description
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).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Kryger, MD, PhD
Organizational Affiliation
University Hospital Frederiksberg and Bispebjerg
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital
City
Copenhagen
State/Province
Frederiksberg
ZIP/Postal Code
2000 F
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22920158
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.
Results Reference
background
PubMed Identifier
33181779
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.
Results Reference
derived
PubMed Identifier
31419219
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.
Results Reference
derived
PubMed Identifier
31122982
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.
Results Reference
derived
PubMed Identifier
25887302
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.
Results Reference
derived
Links:
URL
http://www.parkerinst.dk/
Description
The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital

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

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