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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02114
- Rekrytering
- Massachusetts General Hospital
-
Kontakt:
- Rishabh D Phukan
- Telefonnummer: 617-724-1509
- E-post: rphukan@partners.org
-
Huvudutredare:
- Krikham B. Wood, M.D.
-
Boston, Massachusetts, Förenta staterna, 02115
- Rekrytering
- Brigham & Women's Hospital
-
Kontakt:
- Dana A Leonard, B.A.
- Telefonnummer: N/A/ 617-525-8761
- E-post: dleonard7@partners.org
-
Huvudutredare:
- Christopher M Bono, M.D.
-
Underutredare:
- Mitchel B. Harris, M.D.
-
Boston, Massachusetts, Förenta staterna, 02115
- Rekrytering
- Beth Israel Deaconess Medical Center
-
Kontakt:
- Andrew White, M.D.
-
Huvudutredare:
- Kevin McGuire, M.D.
-
Underutredare:
- Andrew White, M.D.
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv komparator: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Reherniation Rates
Tidsram: 2 years
|
To compare the reherniation rates between the restricted and unrestricted groups.
|
2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Activity/Health Outcomes
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christopher M Bono, M.D., Brigham & Women's Hospital / Harvard Medical School
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2009P001125
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