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

7. august 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Brief intervention only
Brief intervention, an educational model, consists of information
Andet: 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
Andet: 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.
Andet: Exercise therapy
Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Haukeland University Hospital

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2013

Primær færdiggørelse (Faktiske)

1. november 2016

Studieafslutning (Faktiske)

1. november 2016

Datoer for studieregistrering

Først indsendt

24. januar 2013

Først indsendt, der opfyldte QC-kriterier

28. januar 2013

Først opslået (Skøn)

30. januar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. august 2019

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2012/1861

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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