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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02114
- Rekruttering
- Massachusetts General Hospital
-
Ta kontakt med:
- Rishabh D Phukan
- Telefonnummer: 617-724-1509
- E-post: rphukan@partners.org
-
Hovedetterforsker:
- Krikham B. Wood, M.D.
-
Boston, Massachusetts, Forente stater, 02115
- Rekruttering
- Brigham & Women's Hospital
-
Ta kontakt med:
- Dana A Leonard, B.A.
- Telefonnummer: N/A/ 617-525-8761
- E-post: dleonard7@partners.org
-
Hovedetterforsker:
- Christopher M Bono, M.D.
-
Underetterforsker:
- Mitchel B. Harris, M.D.
-
Boston, Massachusetts, Forente stater, 02115
- Rekruttering
- Beth Israel Deaconess Medical Center
-
Ta kontakt med:
- Andrew White, M.D.
-
Hovedetterforsker:
- Kevin McGuire, M.D.
-
Underetterforsker:
- Andrew White, M.D.
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Reherniation Rates
Tidsramme: 2 years
|
To compare the reherniation rates between the restricted and unrestricted groups.
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Activity/Health Outcomes
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Christopher M Bono, M.D., Brigham & Women's Hospital / Harvard Medical School
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2009P001125
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