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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02114
- Werving
- Massachusetts General Hospital
-
Contact:
- Rishabh D Phukan
- Telefoonnummer: 617-724-1509
- E-mail: rphukan@partners.org
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Hoofdonderzoeker:
- Krikham B. Wood, M.D.
-
Boston, Massachusetts, Verenigde Staten, 02115
- Werving
- Brigham & Women's Hospital
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Contact:
- Dana A Leonard, B.A.
- Telefoonnummer: N/A/ 617-525-8761
- E-mail: dleonard7@partners.org
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Hoofdonderzoeker:
- Christopher M Bono, M.D.
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Onderonderzoeker:
- Mitchel B. Harris, M.D.
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Boston, Massachusetts, Verenigde Staten, 02115
- Werving
- Beth Israel Deaconess Medical Center
-
Contact:
- Andrew White, M.D.
-
Hoofdonderzoeker:
- Kevin McGuire, M.D.
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Onderonderzoeker:
- Andrew White, M.D.
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reherniation Rates
Tijdsspanne: 2 years
|
To compare the reherniation rates between the restricted and unrestricted groups.
|
2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Activity/Health Outcomes
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Christopher M Bono, M.D., Brigham & Women's Hospital / Harvard Medical School
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2009P001125
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