Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy
NCT ID: NCT01363830
Last Updated: 2013-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
420 participants
INTERVENTIONAL
2009-08-31
2013-12-31
Brief Summary
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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.
Detailed Description
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* 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Two-Week Post-Operative Restriction
Restrict bending, lifting, and twisting for two-weeks following discectomy.
Two-Week Post-Operative Restriction
Surgeon recommends the patient restrict bending, lifting, and twisting for two-weeks following discectomy.
Six-Week Post-Operative Restriction
Restrict bending, lifting, and twisting for six-weeks following discectomy.
Six-Week Post-Operative Restriction
Surgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy.
Interventions
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Two-Week Post-Operative Restriction
Surgeon recommends the patient restrict bending, lifting, and twisting for two-weeks following discectomy.
Six-Week Post-Operative Restriction
Surgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy.
Eligibility Criteria
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Inclusion Criteria
* English speaking
* single level lumbar disc herniation
* surgical candidate
* no previous lumbar surgery
* primary radicular pain
Exclusion Criteria
* Non-English speaking
* Multi-level lumbar disc herniation
* Disc reherniation
* Previous lumbar surgery
* Primary low back pain
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Christopher Bono
Christopher M. Bono, MD
Principal Investigators
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Christopher M Bono, M.D.
Role: PRINCIPAL_INVESTIGATOR
Brigham & Women's Hospital / Harvard Medical School
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Rishabh D Phukan
Role: primary
Andrew White, M.D.
Role: primary
Dana A Leonard, B.A.
Role: primary
Other Identifiers
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2009P001125
Identifier Type: -
Identifier Source: org_study_id