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- Essai clinique NCT01363830
Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy
Short (2-weeks) Versus Long (6-weeks) Post-Operative Restrictions Following Lumbar Discectomy: A Prospective Randomized Control Study
Post-operative restrictions following lumbar discectomy is a controversial topic. While the most widely accepted protocol restricts bending, lifting, and twisting for four to six weeks following discectomy, a number of studies support an early return to full activity without restriction. Since the goal of discectomy is to promptly provide pain relief and a return to a fully active lifestyle, perhaps post-operative restrictions are more hindering than beneficial.
Hypothesis: Post-operative restrictions following lumbar discectomy do not influence reherniation rate.
Specific Aim 1: To compare the reherniation rates between the 6-weeks of restriction and the 2-weeks of restriction groups.
Specific Aim 2: To determine the return to full activity and return to work dates of both the 6-weeks of restriction and 2-weeks of restriction groups.
Specific Aim 3: To assess the health outcomes of both the 6-weeks of restriction and 2-weeks of restriction groups.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Upon enrollment, subjects will be randomized to the "6-weeks of restriction" or "2-weeks of restriction" group. Subjects will also be asked to provide/complete:
- demographical information
- VAS back and leg score
- Modified Oswestry questionnaire
All of the surgeries will be performed using a so-called limited discectomy in which the herniated disc fragment is removed without an aggressive disc space curettage. Prior to surgery, the subjects' discs will be classified by the Primary Investigator and Site Responsible Investigator on a T-2 weighted MRI according to the Carragee Disc Herniation Classification system.
The discs will be reassessed intraoperatively by the surgeon to confirm the assigned classification. In addition, a radiologist will review a random sampling set of discs on T-2 weighted MRI to eliminate bias and validate the classifications.
Subjects will be followed for a 2 year time period with study visits at 2 weeks, 6 weeks, 3 months, 1 year, and 2 years. At every follow-up visit, the following will be completed and/or documented:
- A reherniation (any clinical symptoms of a reherniation will be verified and documented by MRI)
- Return to full activity and/or work (date)
- VAS back and leg score
- Modified Oswestry questionnaire
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Dana A Leonard
- Numéro de téléphone: 617-525-8761
- E-mail: dleonard7@partners.org
Sauvegarde des contacts de l'étude
- Nom: Christopher M Bono, M.D.
- Numéro de téléphone: 617-732-7238
- E-mail: cmbono@partners.org
Lieux d'étude
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02114
- Recrutement
- Massachusetts General Hospital
-
Contact:
- Rishabh D Phukan
- Numéro de téléphone: 617-724-1509
- E-mail: rphukan@partners.org
-
Chercheur principal:
- Krikham B. Wood, M.D.
-
Boston, Massachusetts, États-Unis, 02115
- Recrutement
- Brigham & Women's Hospital
-
Contact:
- Dana A Leonard, B.A.
- Numéro de téléphone: N/A/ 617-525-8761
- E-mail: dleonard7@partners.org
-
Chercheur principal:
- Christopher M Bono, M.D.
-
Sous-enquêteur:
- Mitchel B. Harris, M.D.
-
Boston, Massachusetts, États-Unis, 02115
- Recrutement
- Beth Israel Deaconess Medical Center
-
Contact:
- Andrew White, M.D.
-
Chercheur principal:
- Kevin McGuire, M.D.
-
Sous-enquêteur:
- Andrew White, M.D.
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18 years of age or older
- English speaking
- single level lumbar disc herniation
- surgical candidate
- no previous lumbar surgery
- primary radicular pain
Exclusion Criteria:
- Less than 18 years of age
- Non-English speaking
- Multi-level lumbar disc herniation
- Disc reherniation
- Previous lumbar surgery
- Primary low back pain
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 |
---|---|
Expérimental: Two-Week Post-Operative Restriction
Restrict bending, lifting, and twisting for two-weeks following discectomy.
|
Surgeon recommends the patient restrict bending, lifting, and twisting for two-weeks following discectomy.
|
Comparateur actif: Six-Week Post-Operative Restriction
Restrict bending, lifting, and twisting for six-weeks following discectomy.
|
Surgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Reherniation Rates
Délai: 2 years
|
To compare the reherniation rates between the restricted and unrestricted groups.
|
2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Activity/Health Outcomes
Délai: 2 years
|
To determine the return to full activity and return to work dates of both the restricted and unrestricted groups.
Also, to assess the health outcomes of both the restricted and unrestricted groups.
|
2 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Christopher M Bono, M.D., Brigham & Women's Hospital / Harvard Medical School
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2009P001125
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