search
Back to results

Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy

Primary Purpose

Lumbar Disc Herniation

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Two-Week Post-Operative Restriction
Six-Week Post-Operative Restriction
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Disc, lumbar, herniation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Brigham & Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Two-Week Post-Operative Restriction

Six-Week Post-Operative Restriction

Arm Description

Restrict bending, lifting, and twisting for two-weeks following discectomy.

Restrict bending, lifting, and twisting for six-weeks following discectomy.

Outcomes

Primary Outcome Measures

Reherniation Rates
To compare the reherniation rates between the restricted and unrestricted groups.

Secondary Outcome Measures

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.

Full Information

First Posted
May 31, 2011
Last Updated
October 18, 2013
Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01363830
Brief Title
Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy
Official Title
Short (2-weeks) Versus Long (6-weeks) Post-Operative Restrictions Following Lumbar Discectomy: A Prospective Randomized Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Disc, lumbar, herniation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Two-Week Post-Operative Restriction
Arm Type
Experimental
Arm Description
Restrict bending, lifting, and twisting for two-weeks following discectomy.
Arm Title
Six-Week Post-Operative Restriction
Arm Type
Active Comparator
Arm Description
Restrict bending, lifting, and twisting for six-weeks following discectomy.
Intervention Type
Behavioral
Intervention Name(s)
Two-Week Post-Operative Restriction
Intervention Description
Surgeon recommends the patient restrict bending, lifting, and twisting for two-weeks following discectomy.
Intervention Type
Behavioral
Intervention Name(s)
Six-Week Post-Operative Restriction
Intervention Description
Surgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy.
Primary Outcome Measure Information:
Title
Reherniation Rates
Description
To compare the reherniation rates between the restricted and unrestricted groups.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Activity/Health Outcomes
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana A Leonard
Phone
617-525-8761
Email
dleonard7@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher M Bono, M.D.
Phone
617-732-7238
Email
cmbono@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M Bono, M.D.
Organizational Affiliation
Brigham & Women's Hospital / Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rishabh D Phukan
Phone
617-724-1509
Email
rphukan@partners.org
First Name & Middle Initial & Last Name & Degree
Krikham B. Wood, M.D.
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew White, M.D.
First Name & Middle Initial & Last Name & Degree
Kevin McGuire, M.D.
First Name & Middle Initial & Last Name & Degree
Andrew White, M.D.
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana A Leonard, B.A.
Phone
617-525-8761
Ext
N/A/
Email
dleonard7@partners.org
First Name & Middle Initial & Last Name & Degree
Christopher M Bono, M.D.
First Name & Middle Initial & Last Name & Degree
Mitchel B. Harris, M.D.

12. IPD Sharing Statement

Learn more about this trial

Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy

We'll reach out to this number within 24 hrs