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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01363830
• Other study ID #: 2009P001125
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2011
• Last updated: October 18, 2013
• Start date: August 2009
• Est. completion date: December 2013

Study information

• Verified date: October 2013
• Source: Brigham and Women's Hospital
• Contact: Dana A Leonard
• Phone: 617-525-8761
• Email: dleonard7[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Beth Israel Deaconess Medical Center, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reherniation Rates	To compare the reherniation rates between the restricted and unrestricted groups.	2 years	No
Secondary	Activity/Health Outcomes	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	No