Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Behavioral: Two-Week Post-Operative Restriction
* Behavioral: Six-Week Post-Operative Restriction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disc, lumbar, herniation