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

NCT ID: NCT01690234

Last Updated: 2012-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

770 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Keywords

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Low back pain Return to work Sickness absence Rehabilitation Multidisciplinary intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Multidisciplinary intervention

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

Group Type EXPERIMENTAL

Multidisciplinary intervention

Intervention Type PROCEDURE

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

Usual care

Intervention from physiotherapist, chiropractor, rheumatologist and social worker.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type PROCEDURE

Intervention from physiotherapist, chiropractor, rheumatologist and social worker.

Interventions

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Multidisciplinary intervention

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

Intervention Type PROCEDURE

Usual care

Intervention from physiotherapist, chiropractor, rheumatologist and social worker.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Back and Rehabilitation Center, Copenhagen

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tom Petersen

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tom Petersen, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Back and Rehabilitaion Center Copenhagen

Annette Fisker, PT, PhDstud

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen, Department of Public Health

Locations

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Back and Rehabilitation Center Copenhagen

Copenhagen, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Tom Petersen, PT, PhD

Role: CONTACT

Phone: +4535304974

Email: [email protected]

Inge Lis Goethgen, Head

Role: CONTACT

Phone: +4535304950

Email: [email protected]

Facility Contacts

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Tom Petersen, PT, PhD

Role: primary

Inge Lis Goethgen, Head

Role: backup

References

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Fisker A, Langberg H, Petersen T, Mortensen OS. Effects of an early multidisciplinary intervention on sickness absence in patients with persistent low back pain-a randomized controlled trial. BMC Musculoskelet Disord. 2022 Sep 10;23(1):854. doi: 10.1186/s12891-022-05807-7.

Reference Type DERIVED
PMID: 36088313 (View on PubMed)

Fisker A, Langberg H, Petersen T, Mortensen OS. Early coordinated multidisciplinary intervention to prevent sickness absence and labour market exclusion in patients with low back pain: study protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2013 Mar 13;14:93. doi: 10.1186/1471-2474-14-93.

Reference Type DERIVED
PMID: 23496897 (View on PubMed)

Other Identifiers

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H-C-2008-112

Identifier Type: -

Identifier Source: org_study_id