Condition category
Musculoskeletal Diseases
Date applied
24/08/2010
Date assigned
25/10/2010
Last edited
21/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Back pain is a common problem that affects most people at some point in their life. It most commonly affects the lower back (Low Back Pain [LBP]). Counselling has been found to be effective at reducing pain, improving physical function and reducing the duration of sick leave for LBP patients. We wish to evaluate the possible long-term effects of the counselling during a 6-year follow-up period.

Who can participate?
LBP patients aged 17-63 who expressed concerns about their ability to maintain their current job.

What does the study involve?
Patients are randomly allocated to receive either usual care (a brief instruction in exercise) or the counselling intervention. The counselling intervention consists of counselling by an occupational physician, a workplace visit if needed, a 6-week interview and a follow-up interview after 3 months by the occupational physician.

What are the possible benefits and risks of participating?
Participants will benefit from a counselling session (occupational physician or usual care). The study follows the rules of using register data in Denmark, where it is a requirement that the participants in a study are protected and not recognisable. We are not aware of any risks involved in participating in the study.

Where is the study run from?
University Hospital Aarhus (Denmark)

When is the study starting and how long is it expected to run for?
January 2007 to January 2016

Who is funding the study?
Danish Research Fund for the Working Environment (Denmark)

Who is the main contact?
Lone Donbæk Jensen
lonjesen@rm.dk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Lone Donbæk Jensen

ORCID ID

Contact details

Arbejdsmedicinsk klinik
Århus Universitets Hospital
Nørrebrogade 44 Bygning 2C
Aarhus
8000
Denmark
+45 (0)89 494290
lonjesen@rm.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10-2005-09 in the Danish Research Fund for the Working Environment

Study information

Scientific title

Vocational prognosis of participants in a randomised trial addressing counselling of low back patients in secondary healthcare - a 6 years follow-up study

Acronym

VAL-300

Study hypothesis

Low back worries, experienced work place barriers and general level of physical activity influence disability defined as level of sick leave, function and pain 3 months after the intervention start.

Added 19/01/2016:
The original randomised study found a statistical and clinical relevant effect on low back pain and function after 3 months in the intervention group. The research question in the actual trial is to investigate the long term effect on vocational prognosis during a 6 years follow up in the intervention group compared to the control group.

Ethics approval

1. Danish Data Protection Agency, 06/03/2006, ref: 2006-41-6190
2. Local ethics and scientific committee, 13/02/2006, ref: 2006-2.0/8

Study design

Randomised controlled intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Low back pain

Intervention

Patients are allocated to either usual care or intervention
Usual care typically consists of a brief instruction in exercises, or readmission to a general practitioner with further contact to physiotherapist or chiropractor treatment.

The intervention consist of a baseline interview and counselling by an occupational physician, a work place visit if needed, a 6-week midway interview, and a concluding follow-up interview with the occupational physician after three months. The focus of the start interview is concrete perceived work place barriers, physical activity and a concluding plan for the next 3 month.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Level of self assessed and register based sick leave
1.1. Cumulated days of sick leave
1.2. Proportion of patient with sick leave at 4, 8 and 12 weeks, compared between intervention and control group.
2. Low back function was assessed using the Roland Morris Disability Questionnaire (RMDQ) at baseline and 3 months
3. Generic health status concerning physical function (PF) and bodily pain (BP) was assessed by SF-36, at baseline and 3 months
4. Low back specific pain was assessed using a 11-point numerical rating scale (NRS) scoring mean pain during the last week

Primary outcome measures at 6 years follow up (added 19/01/2016):
Early retirement

Secondary outcome measures

1. Maximal oxygen uptake (ml O2*min-1*kg-1) measured at baseline and follow up
2. Self reported physical activity and fear avoidance assessed using the Fear Avoidance Believes Questionnaire

Secondary outcome measures at 6 years follow up (added 19/01/2016):
Cumulated sick leave and other non permanent work losses in the follow up period.

Overall trial start date

01/01/2007

Overall trial end date

01/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged 17-63
2. In paid work, paid employment or self-employed
3. Willing to accept a workplace visit if needed
4. Danish-speaking.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Patients referred for surgery
2. Patients with no need for advice concerning workplace barriers or physical activity
3. Pregnancy or becoming pregnant during intervention
4. Other serious illness

Recruitment start date

01/01/2007

Recruitment end date

30/11/2009

Locations

Countries of recruitment

Denmark

Trial participating centre

Arbejdsmedicinsk klinik
Aarhus
8000
Denmark

Sponsor information

Organisation

Danish Research Fund for the Working Environment (Denmark)

Sponsor details

Arbjejdstilsynet
Kontor Effect og Analyse
Postbox 1228
Copenhagen
0900
Denmark
+45 (0)70 121288
at@at.dk

Sponsor type

Research organisation

Website

http://www.at.dk

Funders

Funder type

Research organisation

Funder name

Danish Research Fund for the Working Environment (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/12/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21597108

Publication citations

  1. Results

    Jensen LD, Maribo T, Schiøttz-Christensen B, Madsen FH, Gonge B, Christensen M, Frost P, Counselling low-back-pain patients in secondary healthcare: a randomised trial addressing experienced workplace barriers and physical activity., Occup Environ Med, 2012, 69, 1, 21-28, doi: 10.1136/oem.2010.064055.

Additional files

Editorial Notes

On 19/01/2016 the overall trial end date was changed from 30/11/2009 to 01/01/2016.