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

Low Back Pain Clinical Trial

— GoBack  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02015572
• Other study ID #: GoBack-001
• Status: Active, not recruiting
• Phase: N/A
• First received: November 29, 2013
• Last updated: February 10, 2017
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2017
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 302
• Est. completion date: December 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Occupational intervention
Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.

Other:
• Usual care
Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician

Locations

Country	Name	City	State
Denmark	The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital	Copenhagen	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
Frederiksberg University Hospital	Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accumulated duration of self-assessed sick leave due to LBP		12 months
Other	MRI findings	Degree of degenerative MRI findings in the lumbar spine predicts outcome (sick leave)	Baseline
Other	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
Primary	Accumulated duration of self-assessed sick leave due to LBP		6 months
Secondary	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
Secondary	Changes in Fear Avoidance Beliefs scores	Both Fear Avoidance Beliefs Work Subscale and Physical Activity subscale (questionnaires) will be measured.	6 months
Secondary	Change in Disability	The 24-item Roland Morris Disability Questionnaire will measure participant-rated LBP disability.	6 months
Secondary	Satisfaction with the intervention	Measured on an 11-point NRS with the anchors "not at all satisfied" to "extremely satisfied".	6 months

External Links

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