Comparing multidisciplinary and brief intervention in sick-listed employees with low back pain
| ISRCTN | ISRCTN18609003 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18609003 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/03/2011
- Registration date
- 17/03/2011
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Claus Vinther Nielsen
Scientific
Scientific
Marselisborgcentret
P.P. Oerumsgade 11, bygning 1b
Aarhus C
8000
Denmark
| Claus.Vinther@stab.rm.dk |
Study information
| Study design | Randomised single-centre comparative trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised trial comparing multidisciplinary and brief intervention in sick-listed employees with low back pain |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2004 |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 350 |
| Total final enrolment | 351 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Marselisborgcentret
Aarhus C
8000
Denmark
8000
Denmark
Sponsor information
The Danish Working Environment Research Fund (Denmark)
Government
Government
Postboks 1228
Copenhagen C
0900
Denmark
| at@at.dk | |
"ROR" |
https://ror.org/05fm0gf36 |
Funders
Funder type
Government
The Danish Working Environment Research Fund (Denmark) (ref: No. 20080016279/3)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | subgroup analyses | 25/05/2011 | Yes | No | |
| Results article | 25/08/2012 | 14/11/2022 | Yes | No |
Editorial Notes
14/11/2022: Publication reference and total final enrolment added.
