Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Brigham and Women's Hospital
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Christopher Bono, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01363830
First received: May 31, 2011
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Lumbar Disc Herniation
Behavioral: Two-Week Post-Operative Restriction
Behavioral: Six-Week Post-Operative Restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short (2-weeks) Versus Long (6-weeks) Post-Operative Restrictions Following Lumbar Discectomy: A Prospective Randomized Control Study

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Reherniation Rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To compare the reherniation rates between the restricted and unrestricted groups.


Secondary Outcome Measures:
  • Activity/Health Outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 420
Study Start Date: August 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363830

Contacts
Contact: Dana A Leonard 617-525-8761 dleonard7@partners.org
Contact: Christopher M Bono, M.D. 617-732-7238 cmbono@partners.org

Locations
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Dana A Leonard, B.A.    617-525-8761 ext N/A/    dleonard7@partners.org   
Principal Investigator: Christopher M Bono, M.D.         
Sub-Investigator: Mitchel B. Harris, M.D.         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rishabh D Phukan    617-724-1509    rphukan@partners.org   
Principal Investigator: Krikham B. Wood, M.D.         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Andrew White, M.D.         
Principal Investigator: Kevin McGuire, M.D.         
Sub-Investigator: Andrew White, M.D.         
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Christopher M Bono, M.D. Brigham & Women's Hospital / Harvard Medical School
  More Information

No publications provided

Responsible Party: Christopher Bono, Christopher M. Bono, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01363830     History of Changes
Other Study ID Numbers: 2009P001125
Study First Received: May 31, 2011
Last Updated: October 18, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Disc
lumbar
herniation

Additional relevant MeSH terms:
Hernia
Intervertebral Disk Displacement
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 24, 2014