Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation

Study Overview
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Brief Summary
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This study tests the effectiveness of different treatments for the three most commonly diagnosed lumbar (lower) spine conditions. The purpose of the study is to learn which of two commonly prescribed treatments (surgery and non-surgical therapy) works better for specific types of low back pain. In this part of the study, people with lumbar intervertebral disc herniation (damage to the tissue between the bones of the lower spine, or backbone) will receive either discectomy (surgical removal of herniated disc material) or non-surgical treatment. This study does not cover the cost of treatment.

Detailed Description
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Low back pain is considered one of the most widely experienced health problems in the United States and the world. This condition is the second most frequent condition, after the common cold, for which people see a physician or lose days from work. Estimated costs to those who are severely disabled from low back pain range from $30-70 billion annually. Rates of spinal surgery in the U.S. have increased sharply over time, and researchers have documented 15-fold geographic variation in rates of these surgeries. In many cases, where one lives and who one sees for the problem appear to determine the rates of surgery. Despite these trends, there is little evidence proving the effectiveness of these therapies over non-surgical management. Overall, the SPORT study is a multicenter, randomized, controlled trial for the three most common diagnostic groups for which spine surgery is performed: lumbar intervertebral disc herniation (IDH), spinal stenosis (SpS) and spinal stenosis secondary to degenerative spondylolisthesis (DS). This arm of the trial will deal with patients from the first diagnostic group. The study will compare the most commonly used standard surgical treatments to the most commonly used standard non-surgical treatments. We will conduct the study at 12 sites throughout the United States. The primary endpoint of the study will be changes in health-related quality of life as measured by the SF-36 health status questionnaire. Secondary endpoints will include patient satisfaction with treatment, utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost-effectiveness, resource use, and cost. We will follow patients at 6 weeks and 3, 6, 12, and 24 months to determine their health status, function, satisfaction, and use of health care. In this arm of the trial, we anticipate enrolling and randomly allocating a total of 500 participants. We will track an additional observational cohort to assess health and resource outcomes (1000 participants). Enrollment in the Observational cohort has been completed as of February 2003. We will integrate data from the trial and observational cohorts to formally estimate the cost-effectiveness of surgical versus non-surgical interventions for IDH, SpS, and DS. On the basis of the results of this trial we will, for the first time, have scientific evidence as to the relative effectiveness of surgical versus non-surgical treatment for these three most commonly diagnosed lumbar spine conditions.

Official Title
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Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Intervertebral Disc Herniation (IDH)

Conditions
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Herniated Disc, Low Back Pain

Intervention / Treatment
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* Procedure: Diskectomy
* Procedure: Non-surgical treatments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Duration of symptoms: 6 or more weeks. Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy. Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising. Tests: MRI to confirm diagnosis and level(s). Exclusion Criteria: Previous lumbar spine surgery. Not a surgical candidate for any of these reasons: Overall health which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months. Possible pregnancy. Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no clinical signs or symptoms of the malignancy for at least 5 years. Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine. Age less than 18 years. Cauda Equina syndrome or progressive neurological deficit (usually requiring urgent surgery). Unavailability for follow-up (planning to move, no telephone, etc.) or inability to complete data surveys. Symptoms less than 6 weeks. Patient currently enrolled in any experimental spine related study.

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 |
| --- | --- |
| Active Comparator: Surgery<br>Diskectomy | Procedure: Diskectomy<br>* The surgeon will leave the nerve root freely mobile and undamaged following the procedure. During the procedure, the surgeon may consider using loop magnification or a microscope. The surgical incision will be midline and, after reflecting the paraspinous muscles, the interlaminar level will be identified and entered. The nerve root will be clearly identified and mobilized and then gently retracted to prepare for the discectomy. Removal of the medial border of the superior facet may, in some cases, be necessary in order to have a clear view of the lateral border of the involved nerve root. Following the clear view of the nerve root and mobilization, the IDH will be approached by making a small annular incision if necessary, the fragment of disc will then be removed (i.e., limited disc excision). A search of the canal will follow removal of the fragment, along with probing of the intervertebral-foramen for residual disc or bony pathology.<br>Procedure: Non-surgical treatments<br>* Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated<br>|
| Active Comparator: Non-surgical intervention<br>Non-surgical treatments | Procedure: Non-surgical treatments<br>* Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in health-related quality of life as measured by the SF-36 health status questionnaire |  | Baseline, 6 wks, 3 and 6 mos, Annually thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with treatment |  | Baseline, 6 wks, 3 mos, Annually thereafter | 
| utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness |  | Baseline, 1 yr, 4 yr | 
| resource utilization |  | Baseline, 6 wks, 3 and 6 mos, Annually thereafter | 
| cost |  | Baseline, 6 wks, 3 and 6 mos, Annually thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Intervertebral disc herniation (IDH), Stenosis with degenerative spondylolisthesis (DS), Spinal stenosis (SpS), Low back pain (LBP), Leg pain, Surgical therapy, Non-surgical therapy, Randomized study, Multicenter