Low Back PainTIKINCT01690234
Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain.
A study testing Multidisciplinary intervention in people with Low Back Pain, run by Back and Rehabilitation Center, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Multidisciplinary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Working age adults 18-65
- Low back pain (longer than 2 weeks)
- Sicklisted or at risk
- Employed or unemployed
Who cannot join
- Severe comorbidity
- Pregnancy
- Difficulties in reading Danish language
- Application for early retirement
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Back and Rehabilitation Center Copenhagen
Copenhagen, Copenhagen, 2100
Tom Petersen, PT, PhD, +4535304974, tom.petersen@suf.kk.dk
Inge Lis Goethgen, Head, +4535304950, MW53@suf.kk.dk
About this study
Official title: Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Low Back Pain
- Being tested
- Multidisciplinary intervention, Usual care
- Keywords
- Low back pain, Return to work, Sickness absence, Rehabilitation, Multidisciplinary intervention
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary interventionProcedure or surgery
Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
Usual careProcedure or surgery
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary intervention | Experimental | Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager. Receives: Procedure: Multidisciplinary intervention |
| Usual care | Active comparator | Intervention from physiotherapist, chiropractor, rheumatologist and social worker. Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days off work
Measured: 12 months
Secondary outcomes (1)
Disability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Back and Rehabilitation Center, Copenhagen
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tom Petersen, Back and Rehabilitation Center, Copenhagen
- Investigators
- Tom Petersen, PT, PhD, Principal investigator, Back and Rehabilitaion Center CopenhagenAnnette Fisker, PT, PhDstud, Principal investigator, University of Copenhagen, Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690234
- Sponsor's protocol ID
- H-C-2008-112
- Acronym
- TIKI
- Status last verified
- Sep 2012
- First submitted
- 19 Sep 2012
- Last updated
- 21 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36088313Fisker 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.
PubMed 23496897
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01690234
- Acronym / sponsor ID
- TIKI / H-C-2008-112
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Return to work, Sickness absence, Rehabilitation, Multidisciplinary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- Back and Rehabilitation Center, CopenhagenOther government
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2014 (estimated)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary intervention | Experimental | Procedure: Multidisciplinary interventionEarly coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager. |
| Usual care | Active comparator | Procedure: Usual careIntervention from physiotherapist, chiropractor, rheumatologist and social worker. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Working age adults 18-65
- Low back pain (longer than 2 weeks)
- Sicklisted or at risk
- Employed or unemployed
Key exclusion criteria (4 listed)
- Severe comorbidity
- Pregnancy
- Difficulties in reading Danish language
- Application for early retirement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary interventionEarly coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager. | Procedure or surgery | Multidisciplinary intervention |
| Usual careIntervention from physiotherapist, chiropractor, rheumatologist and social worker. | Procedure or surgery | Usual care |
Primary outcome
Number of days off work
Time frame: 12 months
1 secondary outcome
Disability
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2012.
- Derived from this study: PubMed 36088313Fisker 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.
- Derived from this study: PubMed 23496897Fisker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Petersen, PT, PhD principal investigator
Back and Rehabilitaion Center Copenhagen
Annette Fisker, PT, PhDstud principal investigator
University of Copenhagen, Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary intervention in people with Low Back Pain, run by Back and Rehabilitation Center, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Petersen, PT, PhD (+4535304974, tom.petersen@suf.kk.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days off work (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690234, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2012.