Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | August 2009 |
| End Date: | December 2013 |
| Contact: | Dana A Leonard |
| Email: | dleonard7@partners.org |
| Phone: | 617-525-8761 |
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.
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.
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
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
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
We found this trial at
3
sites
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
Click here to add this to my saved trials
Click here to add this to my saved trials
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
Click here to add this to my saved trials