Short (2-weeks) Versus Long (6-weeks) Post-Operative Restrictions Following Lumbar Discectomy: A Prospective Randomized Control Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 420
- Locations
- 6
- Primary Endpoint
- Reherniation Rates
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Reherniation Rates
Time Frame: 2 years
To compare the reherniation rates between the restricted and unrestricted groups.
Secondary Outcomes
- Activity/Health Outcomes(2 years)
Investigators
Christopher Bono
Christopher M. Bono, MD
Brigham and Women's Hospital