Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Behavioral: Two-Week Post-Operative Restriction; Behavioral: Six-Week Post-Operative Restriction

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:

• 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 Type: Interventional
• Enrollment (Anticipated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dana A Leonard; Phone Number: 617-525-8761; Email: dleonard7@partners.org
• Study Contact Backup: Name: Christopher M Bono, M.D.; Phone Number: 617-732-7238; Email: cmbono@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Rishabh D Phukan; Phone Number: 617-724-1509; Email: rphukan@partners.org
      • Principal Investigator: Krikham B. Wood, M.D.
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women's Hospital
      • Contact: Dana A Leonard, B.A.; Phone Number: N/A/ 617-525-8761; Email: dleonard7@partners.org
      • Principal Investigator: Christopher M Bono, M.D.
      • Sub-Investigator: Mitchel B. Harris, M.D.
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Andrew White, M.D.
      • Principal Investigator: Kevin McGuire, M.D.
      • Sub-Investigator: Andrew White, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Two-Week Post-Operative Restriction; Restrict bending, lifting, and twisting for two-weeks following discectomy.	Behavioral: Two-Week Post-Operative Restriction; Surgeon recommends the patient restrict bending, lifting, and twisting for two-weeks following discectomy.
Active Comparator: Six-Week Post-Operative Restriction; Restrict bending, lifting, and twisting for six-weeks following discectomy.	Behavioral: Six-Week Post-Operative Restriction; Surgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reherniation Rates	To compare the reherniation rates between the restricted and unrestricted groups.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts General Hospital; Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Christopher M Bono, M.D., Brigham & Women's Hospital / Harvard Medical School

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 2, 2011

Study Record Updates

• Last Update Posted (Estimate): October 22, 2013
• Last Update Submitted That Met QC Criteria: October 18, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: lumbar; Disc; herniation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: 2009P001125