- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01690234
Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. (TIKI)
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.
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Tom Petersen, PT, PhD
- Telefonnummer: +4535304974
- E-post: tom.petersen@suf.kk.dk
Studer Kontakt Backup
- Navn: Inge Lis Goethgen, Head
- Telefonnummer: +4535304950
- E-post: MW53@suf.kk.dk
Studiesteder
-
-
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Copenhagen, Danmark, 2100
- Rekruttering
- Back and Rehabilitation Center Copenhagen
-
Hovedetterforsker:
- Tom Petersen, PT, PhD
-
Ta kontakt med:
- Tom Petersen, PT, PhD
- Telefonnummer: +4535304974
- E-post: tom.petersen@suf.kk.dk
-
Ta kontakt med:
- Inge Lis Goethgen, Head
- Telefonnummer: +4535304950
- E-post: MW53@suf.kk.dk
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Multidisciplinary intervention
Early coordinated multidisciplinary intervention.
Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
|
Early coordinated multidisciplinary intervention.
Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
|
Aktiv komparator: Usual care
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
|
Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of days off work
Tidsramme: 12 months
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Disability
Tidsramme: 12 months
|
12 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Tom Petersen, PT, PhD, Back and Rehabilitaion Center Copenhagen
- Hovedetterforsker: Annette Fisker, PT, PhDstud, University of Copenhagen, Department of Public Health
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-C-2008-112
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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