- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Hordaland
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Bergen, Hordaland, Norwegen
- Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: 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.
|
Aktiver Komparator: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
Zeitfenster: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Disability and beliefs about the condition
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline and 6-8 weeks postsurgery postsurgery
|
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
Zeitfenster: 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
Zeitfenster: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Recidive prolapse
Zeitfenster: 1 year postsurgery
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1 year postsurgery
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Kari Indrekvam, phd, MD, Helse Bergen HF, Haukeland University Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2012/1861
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