Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy

Lumbar Disc Herniation Clinical Trial

Official title: Short (2-weeks) Versus Long (6-weeks) Post-Operative Restrictions Following Lumbar Discectomy: A Prospective Randomized Control Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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:

• 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

• NCT number: NCT01363830
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Contact: Dana A Leonard
• Phone: 617-525-8761
• Email: dleonard7@partners.org
• Status: Recruiting
• Phase: N/A
• Start date: August 2009
• Completion date: December 2013