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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/21597108
Publication citations
-
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.