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Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain.

Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. A Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01690234
Acronym
TIKI
Enrollment
770
Registered
2012-09-21
Start date
2009-09-30
Completion date
2014-10-31
Last updated
2012-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Low back pain, Return to work, Sickness absence, Rehabilitation, Multidisciplinary intervention

Brief summary

In Denmark the number of patients, sick listed for more than four weeks is increasing, and patients suffering from musculoskeletal disorders make one third of the total amount of long-term absenteeism. Compared to other diagnoses, patients suffering from musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. The aim of this study is to evaluate the effect of a work oriented multidisciplinary intervention. A randomized controlled trial will include 770 patients with low back pain. The study population consists of patients, who are sick listed or at risk of sick leave due to LBP. The control group is treated with usual care in a team with participation of a physiotherapist, a chiropractor, a rheumatologist and a local employed social worker The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist and a social worker from the local sickness benefit office. The treating physiotherapist will be the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days of work. Secondary outcomes are disability, pain, and quality of life. This large RCT study is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the sickness benefit office participating in team meetings.

Interventions

Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.

PROCEDUREUsual care

Intervention from physiotherapist, chiropractor, rheumatologist and social worker.

Sponsors

Back and Rehabilitation Center, Copenhagen
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Working age adults 18-65 * Low back pain (longer than 2 weeks) * Sicklisted or at risk * Employed or unemployed

Exclusion criteria

* Severe comorbidity * Pregnancy * Difficulties in reading Danish language * Application for early retirement

Design outcomes

Primary

MeasureTime frame
Number of days off work12 months

Secondary

MeasureTime frame
Disability12 months

Countries

Denmark

Contacts

Primary ContactTom Petersen, PT, PhD
tom.petersen@suf.kk.dk+4535304974
Backup ContactInge Lis Goethgen, Head
MW53@suf.kk.dk+4535304950

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026