- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Hordaland
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Bergen, Hordaland, Norwegia
- Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Brief intervention only
Brief intervention, an educational model, consists of information
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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.
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Aktywny komparator: Exercise group
Brief educational intervention combined with exercise therapy
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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
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
Ramy czasowe: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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Disability and beliefs about the condition
Ramy czasowe: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery
Ramy czasowe: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery
Ramy czasowe: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Change from baseline in Fear-Avoidance Beliefs Questionnaire (physical activity) at 6-8 weeks and 1 year postsurgery
Ramy czasowe: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Change from baseline in anticipation to return to work at 6-8 weeks postsurgery
Ramy czasowe: Baseline and 6-8 weeks postsurgery postsurgery
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Baseline and 6-8 weeks postsurgery postsurgery
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Change from baseline in health condition at 6-8 weeks and 1 year postsurgery
Ramy czasowe: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery
Ramy czasowe: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Recidive prolapse
Ramy czasowe: 1 year postsurgery
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1 year postsurgery
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Kari Indrekvam, phd, MD, Helse Bergen HF, Haukeland University Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2012/1861
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Badania kliniczne na Brief intervention, an educational model
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University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)Zakończony