Evaluation of a work place directed intervention to enhance vocational prognosis among low back patients
| ISRCTN | ISRCTN13071157 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13071157 |
| Secondary identifying numbers | 10-2005-09 in the Danish Research Fund for the Working Environment |
- Submission date
- 24/08/2010
- Registration date
- 25/10/2010
- Last edited
- 21/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Arbejdsmedicinsk klinik
Århus Universitets Hospital
Nørrebrogade 44 Bygning 2C
Aarhus
8000
Denmark
| Phone | +45 (0)89 494290 |
|---|---|
| lonjesen@rm.dk |
Study information
| Study design | Randomised controlled intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| 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 |
| Study acronym | VAL-300 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2007 |
| Completion date | 01/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 30/11/2009 |
Locations
Countries of recruitment
- Denmark
Study participating centre
8000
Denmark
Sponsor information
Research organisation
Arbjejdstilsynet
Kontor Effect og Analyse
Postbox 1228
Copenhagen
0900
Denmark
| Phone | +45 (0)70 121288 |
|---|---|
| at@at.dk | |
| Website | http://www.at.dk |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No |
Editorial Notes
On 19/01/2016 the overall trial end date was changed from 30/11/2009 to 01/01/2016.
