Plain English Summary
Background and study aims
Low back pain (LBP) is a common problem affecting most people during their lifetime. Many people who experience LBP will recover quickly with no significant impact to their lives, but for some people the pain turns into a long term condition which can affect their ability to work. There are two common treatment plans which are used for people suffering from LBP. The first is a treatment plan involving healthcare professionals such as doctors and physiotherapists (brief intervention). The second is a more in-depth treatment plan which takes into account occupational and social factors, as well as the medical care from healthcare professionals (multidisciplinary intervention).
In a recent study, the effects of multidisciplinary and brief interventions were compared, to find whether they had an effect on returning to work. It was found that there was no difference between the two types of intervention on the whole, but differences were found in subgroups of people with different work situations.
The aim of this study is to test whether people who have low influence within their job role and are at risk of losing their job would benefit more from multidisciplinary interventions than those with influence in their job role who are not at risk of losing their job.
Who can participate?
Adults on partial (working hours reduced by up to 25%) or full (working hours reduced by 100%) sick leave from work for 4 to 12 weeks due to low back pain.
What does the study involve?
Participants are split into two groups, one group including those not at risk of losing their job due to influence in the workplace, and the other including those at risk of losing their job due to low influence in the work place. These two groups are then randomly allocated into two further groups. The first group is provided with information about pain management and provided with a physiotherapist appointment. The second group is provided with the same, but their recovery is also supported by a group of experts to ensure that an individual treatment plan is provided.
What are the possible benefits and risks of participating?
Benefits of participating include receiving extra treatment to what is usually offered, as well as receiving treatment co-ordinated with social services. There are not risks of participating in the study.
Where is the study run from?
Marselisborgcenter (Denmark)
When is the study starting and how long is it expected to run for?
October 2010 to December 2019
Who is funding the study?
Central Region Denmark (Marselisborgcentret and Regional Hospital Silkeborg)
Who is the main contact?
Professor Claus Vinther Nielsen
Trial website
Contact information
Type
Public
Primary contact
Prof Claus VintherNielsen
ORCID ID
Contact details
PP Ørumsgade 9-11
bygning 1B
Aarhus
8000 C
Denmark
+45 7841 4440
claus.vinther@stab.rm.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparing multidisciplinary and brief hospital-based intervention in sick-listed employees with low back pain
Acronym
Study hypothesis
1. Return to work is faster in sick-listed subjects with low back pain, low influence at work or at risk of losing their job, if they receive a hospital-based multidisciplinary team-intervention in addition to a brief intervention than in subjects who only receive the brief intervention consisting of a clinical examination and advice given by a rehabilitation doctor and a physiotherapist.
2. Return to work is faster in sick-listed subjects with low back pain, influence at work and without risk of losing their job, if they receive a hospital-based brief intervention as compared with a multidisciplinary team-intervention in addition to a brief intervention.
Ethics approval
Videnskabsetisk komite for Region Midtjylland, 01/10/2010, ref: M-20100193
Study design
Randomised single-centre comparative trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Low back pain
Intervention
Brief intervention:
A standard clinical low backpain (LBP) examination is carried out by a doctor. Patients with non-specific LBP are informed about the difficulties of visualising the cause of pain with certainty, the best documented treatment being exercise and training and psychological distress possibly worsening and prolonging pain. Patients with nerve root pain are informed about the good spontaneous prognosis and about the possibility of surgery if no improvement occurred. Furthermore, they are informed about exercise being beneficial if leg pain did not worsen. Information is given in a reassuring way and medical pain management was adjusted. The participants are advised to resume work when possible. A physiotherapy examination included a standardised, mechanical evaluation and advice on exercise was chosen accordingly. General advice is given to increase physical activity and exercise. In order to ensure coordination between stake holders, copies of the medical records are always sent to the participant, the general practitioner and the municipal social services responsible for reimbursement of sick leave compensation. For all participants, a follow-up visit at the physiotherapist is scheduled two weeks later and a follow-up visit at the doctor is arranged for participants needing answers in relation to test results.
Multidisciplinary intervention:
In addition to the brief clinical intervention described above, participants allocated to the multidisciplinary intervention group are scheduled for an interview with a case manager within two to three workdays. This interview is standardised and includes questions of work history, private life and questions on how pain and disability was perceived. This normally lasts for one to two hours. The participant is seen once or more times by the case manager depending on need and progress. The case manager and the participant together makes a tailored rehabilitation plan aiming at full or partial return to work (RTW). If this is deemed unrealistic, a plan towards staying on the labor market in other ways is made, for instance by jobs supported by the social system. Each case is discussed several times by the entire multidisciplinary team including the rehabilitation doctor, a specialist in clinical social medicine, a physiotherapist, a social worker and an occupational therapist. Appointments with other members of the team and meetings at the work place or at the social service centre are regularly arranged. The case manager keeps in contact with the participant and problems are discussed at regular team conferences where the participant is not present. The case is closed when the participant resumed work or if this is deemed impossible (in the latter case the social worker at the social service centre is contacted). One of three different persons could be assigned as case manager (the specialist in clinical social medicine, the social worker or the occupational therapist).
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Return to work (RTW), which will be measured during a follow-up period of one year. RTW is here defined as the first 4-week period after sick-listing, where sick-leave and disability benefits are not received. Data will be retrieved from registers of public social transfer income.
Secondary outcome measures
Disability will be measured based on pain and functioning based on questionnaire data retrieved one year after inclusion. The Roland Morris Disability questionnaire is used (23 items).
Overall trial start date
01/01/2010
Overall trial end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 16-60 years
2. On partial (contracted hours reduced by at least 25%) or fully (contracted hours reduced by 100%) on sick leave from work for 4 to 12 weeks due to Low Back Pain
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Unemployment
2. Continuing or progressive signs or symptoms of nerve root affection implicating plans for surgery
3. Low back surgery within the last year or specific back diseases (e.g. tumor)
4. Pregnancy
5. Known dependency on drugs or alcohol
6. Any primary psychiatric disease
Recruitment start date
01/10/2010
Recruitment end date
01/07/2016
Locations
Countries of recruitment
Denmark
Trial participating centre
Marselisborgcenter
Sønder Jernbanevej 18, 2. sal
3400 Hillerød
Aarhus
8000
Denmark
Trial participating centre
Spine clinic, Regional Hospital Silkeborg
Falkevej 3
8600 Silkeborg
Silkeborg
8600
Denmark
Sponsor information
Organisation
Central Region Denmark (Marselisborgcentret and Regional Hospital Silkeborg)
Sponsor details
PP Ørumsgade 9-11
Bygning 1B
Aarhus
8000 C
Denmark
+45 7841 4440
claus.vinther@stab.rm.dk
Sponsor type
Research organisation
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Central Region Denmark (Marselisborgcentret and Regional Hospital Silkeborg)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Effects at one-year follow-up will be published at the end of 2017.
Intention to publish date
31/12/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 protocol in https://pubmed.ncbi.nlm.nih.gov/29246257/ (added 15/01/2021)