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Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy

18. oktober 2013 opdateret af: Christopher Bono, Brigham and Women's Hospital

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

420

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Rekruttering
        • Massachusetts General Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Krikham B. Wood, M.D.
      • Boston, Massachusetts, Forenede Stater, 02115
        • Rekruttering
        • Brigham & Women's Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christopher M Bono, M.D.
        • Underforsker:
          • Mitchel B. Harris, M.D.
      • Boston, Massachusetts, Forenede Stater, 02115
        • Rekruttering
        • Beth Israel Deaconess Medical Center
        • Kontakt:
          • Andrew White, M.D.
        • Ledende efterforsker:
          • Kevin McGuire, M.D.
        • Underforsker:
          • Andrew White, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Two-Week Post-Operative Restriction
Restrict bending, lifting, and twisting for two-weeks following discectomy.
Adfærdsmæssigt: Two-Week Post-Operative Restriction
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.
Adfærdsmæssigt: Six-Week Post-Operative Restriction
Surgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reherniation Rates
Tidsramme: 2 years
To compare the reherniation rates between the restricted and unrestricted groups.
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Brigham and Women's Hospital

Samarbejdspartnere

Massachusetts General Hospital
Beth Israel Deaconess Medical Center

Efterforskere

  • Ledende efterforsker: Christopher M Bono, M.D., Brigham & Women's Hospital / Harvard Medical School

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2009

Primær færdiggørelse (Forventet)

1. december 2013

Studieafslutning (Forventet)

1. december 2013

Datoer for studieregistrering

Først indsendt

31. maj 2011

Først indsendt, der opfyldte QC-kriterier

1. juni 2011

Først opslået (Skøn)

2. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. oktober 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2009P001125

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lumbal diskusprolaps

Kliniske forsøg med Two-Week Post-Operative Restriction

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in New Zealand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner