Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two-Week Post-Operative Restriction | Experimental | Restrict bending, lifting, and twisting for two-weeks following discectomy. |
|
| Six-Week Post-Operative Restriction | Active Comparator | Restrict bending, lifting, and twisting for six-weeks following discectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two-Week Post-Operative Restriction | Behavioral | Surgeon recommends the patient restrict bending, lifting, and twisting for two-weeks following discectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reherniation Rates | To compare the reherniation rates between the restricted and unrestricted groups. | 2 years |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dana A Leonard | Contact | 617-525-8761 | dleonard7@partners.org | |
| Christopher M Bono, M.D. | Contact | 617-732-7238 | cmbono@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Christopher M Bono, M.D. | Brigham & Women's Hospital / Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
Not provided
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Six-Week Post-Operative Restriction | Behavioral | Surgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy. |
|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Brigham & Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| D013568 | Pathological Conditions, Signs and Symptoms |