Condition category
Musculoskeletal Diseases
Date applied
04/03/2011
Date assigned
17/03/2011
Last edited
27/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2011 subgroup analyses in http://www.ncbi.nlm.nih.gov/pubmed/21612625

Publication citations

  1. 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.

Additional files

Editorial Notes