- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01779544
Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention
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:
- 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.
- Exercises which are instructed after lumbar disc surgery in a rehabilitation program, are being done by the patients.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Hordaland
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Bergen, Hordaland, Norvegia
- Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik
-
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Brief intervention only
Brief intervention, an educational model, consists of information
|
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.
|
|
Comparatore attivo: Exercise group
Brief educational intervention combined with exercise therapy
|
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.
Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
Lasso di tempo: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Disability and beliefs about the condition
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
|
Recidive prolapse
Lasso di tempo: 1 year postsurgery
|
1 year postsurgery
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Kari Indrekvam, phd, MD, Helse Bergen HF, Haukeland University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2012/1861
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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