- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Hordaland
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Bergen, Hordaland, Norvège
- Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
|
Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
Délai: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Disability and beliefs about the condition
Délai: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
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
Délai: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
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
Délai: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
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
Délai: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
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
Délai: 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
Délai: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
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
Délai: 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
Délai: 1 year postsurgery
|
1 year postsurgery
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Kari Indrekvam, phd, MD, Helse Bergen HF, Haukeland University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2012/1861
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