Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. (TIKI)
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Multidisciplinary intervention
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Return to work, Sickness absence, Rehabilitation, Multidisciplinary intervention
Eligibility 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
Sites / Locations
- Back and Rehabilitation Center CopenhagenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multidisciplinary intervention
Usual care
Arm Description
Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
Outcomes
Primary Outcome Measures
Number of days off work
Secondary Outcome Measures
Disability
Full Information
NCT ID
NCT01690234
First Posted
September 19, 2012
Last Updated
September 19, 2012
Sponsor
Back and Rehabilitation Center, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01690234
Brief Title
Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain.
Acronym
TIKI
Official Title
Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Back and Rehabilitation Center, Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Return to work, Sickness absence, Rehabilitation, Multidisciplinary intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
770 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multidisciplinary intervention
Arm Type
Experimental
Arm Description
Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
Intervention Type
Procedure
Intervention Name(s)
Multidisciplinary intervention
Intervention Description
Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
Primary Outcome Measure Information:
Title
Number of days off work
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Disability
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Petersen, PT, PhD
Phone
+4535304974
Email
tom.petersen@suf.kk.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Inge Lis Goethgen, Head
Phone
+4535304950
Email
MW53@suf.kk.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Petersen, PT, PhD
Organizational Affiliation
Back and Rehabilitaion Center Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annette Fisker, PT, PhDstud
Organizational Affiliation
University of Copenhagen, Department of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Back and Rehabilitation Center Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Petersen, PT, PhD
Phone
+4535304974
Email
tom.petersen@suf.kk.dk
First Name & Middle Initial & Last Name & Degree
Inge Lis Goethgen, Head
Phone
+4535304950
Email
MW53@suf.kk.dk
First Name & Middle Initial & Last Name & Degree
Tom Petersen, PT, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
36088313
Citation
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.
Results Reference
derived
PubMed Identifier
23496897
Citation
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.
Results Reference
derived
Learn more about this trial
Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain.
We'll reach out to this number within 24 hrs