Contact information
Type
Scientific
Primary contact
Dr Claus Vinther Nielsen
ORCID ID
Contact details
Marselisborgcentret
P.P. Oerumsgade 11
bygning 1b
Aarhus C
8000
Denmark
Claus.Vinther@stab.rm.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised trial comparing multidisciplinary and brief intervention in sick-listed employees with low back pain
Acronym
Study hypothesis
Return to work, pain and disability improves more in sick-listed subjects with low back pain 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.
Ethics approval
The study was discussed with the regional research ethics committee. Approval was not considered necessary by the committee, because all participants received the best available clinical care and no biological material was involved.
We have later acquired a written response from the Research Ethics Committee of Central Region Denmark (komite@rm.dk) filed as:
Number: Forespørgsel 38/2010: The Study does not fall within the scope of the work of the Committee according to the Act on Biomedical Research Ethics Committee System and The Processing of Biomedical Research Projects 8, section 1 and 7, number 1 and therefore shall not be notified to the Committee.
Study design
Randomised single-centre comparative trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Low back pain
Intervention
Brief intervention:
A standard clinical low backpain (LBP) examination was carried out by a doctor. Patients with non-specific LBP were 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 were informed about the good spontaneous prognosis and about the possibility of surgery if no improvement occurred. Furthermore, they were informed about exercise being beneficial if leg pain did not worsen. Information was given in a reassuring way and medical pain management was adjusted. The participants were advised to resume work when possible. A physiotherapy examination included a standardised, mechanical evaluation and advice on exercise was chosen accordingly. General advice was given to increase physical activity and exercise. In order to ensure coordination between stake holders, copies of the medical records were 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 was scheduled two weeks later and a follow-up visit at the doctor was 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 were scheduled for an interview with a case manager within two to three workdays. This interview was standardised and included questions of work history, private life and questions on how pain and disability was perceived. It normally lasted for one to two hours. The participant was seen once or more times by the case manager depending on need and progress. The case manager and the participant together made a tailored rehabilitation plan aiming at full or partial RTW. If this was deemed unrealistic, a plan towards staying on the labor market in other ways was made, for instance by jobs supported by the social system. Each case was 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 were regularly arranged. The case manager kept in contact with the participant and problems were discussed at regular team conferences where the participant was not present. The case was closed when the participant resumed work or if this was deemed impossible (in the latter case the social worker at the social service centre was contacted). Three different persons could be assigned as case manager (the specialist in clinical social medicine, the social worker or the occupational therapist). Every two weeks, supervision of the entire team was arranged for 1-2 hours by a former general practitioner specialised in cognitive therapy to ensure a standardised intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Return to work using register-based data on sick leave.
Secondary outcome measures
1. Pain (Low Back Pain Rating scale)
2. Disability (Roland Morris Disability Questionnaire)
Overall trial start date
01/10/2004
Overall trial end date
01/07/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 16-60 years
2. Partly or fully sick-listed from work for 4 to 12 weeks due to Low Back Pain
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
350
Participant exclusion criteria
1. Unemployed
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. Pregnant
5. Known dependency on drugs or alcohol
6. Any primary psychiatric disease
Recruitment start date
01/10/2004
Recruitment end date
01/07/2007
Locations
Countries of recruitment
Denmark
Trial participating centre
Marselisborgcentret
Aarhus C
8000
Denmark
Sponsor information
Organisation
The Danish Working Environment Research Fund (Denmark)
Sponsor details
Postboks 1228
Copenhagen C
0900
Denmark
at@at.dk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Danish Working Environment Research Fund (Denmark) (ref: No. 20080016279/3)
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
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 subgroup analyses in http://www.ncbi.nlm.nih.gov/pubmed/21612625
Publication citations
-
Subgroup analyses
Stapelfeldt CM, Christiansen DH, Jensen OK, Nielsen CV, Petersen KD, Jensen C, Subgroup analyses on return to work in sick-listed employees with low back pain in a randomised trial comparing brief and multidisciplinary intervention., BMC Musculoskelet Disord, 2011, 12, 112, doi: 10.1186/1471-2474-12-112.