Short (2-weeks) Versus Long (6-weeks) Post-Operative Restrictions Following Lumbar Discectomy: A Prospective Randomized Control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 420
- 试验地点
- 3
- 主要终点
- Reherniation Rates
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •English speaking
- •single level lumbar disc herniation
- •surgical candidate
- •no previous lumbar surgery
- •primary radicular pain
排除标准
- •Less than 18 years of age
- •Non-English speaking
- •Multi-level lumbar disc herniation
- •Disc reherniation
- •Previous lumbar surgery
- •Primary low back pain
研究组 & 干预措施
Two-Week Post-Operative Restriction
Restrict bending, lifting, and twisting for two-weeks following discectomy.
干预措施: Two-Week Post-Operative Restriction (Behavioral)
Six-Week Post-Operative Restriction
Restrict bending, lifting, and twisting for six-weeks following discectomy.
干预措施: Six-Week Post-Operative Restriction (Behavioral)
结局指标
主要结局
Reherniation Rates
时间窗: 2 years
To compare the reherniation rates between the restricted and unrestricted groups.
次要结局
- Activity/Health Outcomes(2 years)
研究者
Christopher Bono
Christopher M. Bono, MD
Brigham and Women's Hospital