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Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention

7. august 2019 oppdatert av: Haukeland University Hospital

Rehabilitation After Lumbar Surgery

Rehabilitation after lumbar disc surgery (prolapse) focuses on various elements such as endurance, strength, stretching and information. Evidence concludes that it is not harmful to return to activity after lumbar disc surgery, and restrictions to activities after these operations are today more or less nonexistent. Some studies have shown that high intensity programs might be more effective, but they are probably more expensive. In recent years cognitive interventions have received more attention in rehabilitation programs after lumbar disc surgery. The cognitive approach is focused on providing patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases. A goal of the rehabilitation is to get the patient to resume normal activities. Reviews ask for how much treatment are needed in a rehabilitation program after lumbar disc surgery.

The study will be a randomized clinical trial. The study will compare two different post-operative rehabilitation programs (general information or general information + exercise therapy). Both groups will begin treatment 1 day after surgery. Subjects in exercise therapy group are supposed to continue with exercises 3 months.

In this study the following hypothesis will be studied:

  1. Brief intervention, an educational model, alone after lumbar disc surgery do have the same effect on pain in legs and low back as brief intervention, an educational model, combined with exercise therapy.
  2. Exercises which are instructed after lumbar disc surgery in a rehabilitation program, are being done by the patients.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Norge
    • Hordaland
      • Bergen, Hordaland, Norge
        • Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosed with lumbar disc prolapse with radicular pain
  • Age between 18 and 60

Exclusion Criteria:

  • Previous lumbar disc surgery (prolapse)
  • Spondyloarthritis
  • Arthritis
  • Systematic disease
  • Heart disease
  • Does not understand Norwegian language, spoken or in writing

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Brief intervention only
Brief intervention, an educational model, consists of information
Annen: Brief intervention, an educational model
The goal of the the brief intervention is to provide the patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases.
Aktiv komparator: Exercise group
Brief educational intervention combined with exercise therapy
Annen: Brief intervention, an educational model
The goal of the the brief intervention is to provide the patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases.
Annen: Exercise therapy
Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
Tidsramme: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Baseline, 6-8 weeks postsurgery and 1 year postsurgery

Sekundære resultatmål

Resultatmål
Tidsramme
Disability and beliefs about the condition
Tidsramme: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery
Tidsramme: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery
Tidsramme: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Change from baseline in Fear-Avoidance Beliefs Questionnaire (physical activity) at 6-8 weeks and 1 year postsurgery
Tidsramme: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Change from baseline in anticipation to return to work at 6-8 weeks postsurgery
Tidsramme: Baseline and 6-8 weeks postsurgery postsurgery
Baseline and 6-8 weeks postsurgery postsurgery
Change from baseline in health condition at 6-8 weeks and 1 year postsurgery
Tidsramme: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery
Tidsramme: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Recidive prolapse
Tidsramme: 1 year postsurgery
1 year postsurgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Haukeland University Hospital

Etterforskere

  • Studieleder: Kari Indrekvam, phd, MD, Helse Bergen HF, Haukeland University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2013

Primær fullføring (Faktiske)

1. november 2016

Studiet fullført (Faktiske)

1. november 2016

Datoer for studieregistrering

Først innsendt

24. januar 2013

Først innsendt som oppfylte QC-kriteriene

28. januar 2013

Først lagt ut (Anslag)

30. januar 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. august 2019

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2012/1861

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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