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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Back and Rehabilitation Center, Copenhagen
Sponsor:
Information provided by (Responsible Party):
Tom Petersen, Back and Rehabilitation Center, Copenhagen
ClinicalTrials.gov Identifier:
NCT01690234
First received: September 19, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Low Back Pain
Procedure: Multidisciplinary intervention
Procedure: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Back and Rehabilitation Center, Copenhagen:

Primary Outcome Measures:
  • Number of days off work [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 770
Study Start Date: September 2009
Estimated Study Completion Date: October 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multidisciplinary intervention
Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
Procedure: Multidisciplinary intervention
Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
Active Comparator: Usual care
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
Procedure: Usual care
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690234

Contacts
Contact: Tom Petersen, PT, PhD +4535304974 tom.petersen@suf.kk.dk
Contact: Inge Lis Goethgen, Head +4535304950 MW53@suf.kk.dk

Locations
Denmark
Back and Rehabilitation Center Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Tom Petersen, PT, PhD    +4535304974    tom.petersen@suf.kk.dk   
Contact: Inge Lis Goethgen, Head    +4535304950    MW53@suf.kk.dk   
Principal Investigator: Tom Petersen, PT, PhD         
Sponsors and Collaborators
Back and Rehabilitation Center, Copenhagen
Investigators
Principal Investigator: Tom Petersen, PT, PhD Back and Rehabilitaion Center Copenhagen
Principal Investigator: Annette Fisker, PT, PhDstud University of Copenhagen, Department of Public Health
  More Information

No publications provided by Back and Rehabilitation Center, Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tom Petersen, Physiotherapist, Back and Rehabilitation Center, Copenhagen
ClinicalTrials.gov Identifier: NCT01690234     History of Changes
Other Study ID Numbers: H-C-2008-112
Study First Received: September 19, 2012
Last Updated: September 19, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Back and Rehabilitation Center, Copenhagen:
Low back pain
Return to work
Sickness absence
Rehabilitation
Multidisciplinary intervention

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014