Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy
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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 |
- Reherniation Rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]To compare the reherniation rates between the restricted and unrestricted groups.
- 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 |
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| Contact: Rachel M Deering, M.P.H. | 617-525-8761 | rmdeering@partners.org |
| Contact: Christopher M Bono, M.D. | 617-732-7238 | cmbono@partners.org |
| United States, Massachusetts | |
| Brigham & Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Rachel M Deering, M.P.H. 617-525-8761 ext N/A/ rmdeering@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: Charles S Carrier, B.A. 617-724-1509 cscarrier@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. | |
| 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: | February 26, 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 May 22, 2013