Low Back Pain Clinical Trial
Official title:
Spine Patient Outcomes Research Trial (SPORT): A Multicenter Trial for Spinal Stenosis (SpS)
This study tests the effectiveness of different treatments for the three most commonly
diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of
two commonly prescribed treatments (surgery and nonsurgical therapy) works better for
specific types of low back pain. Low back pain is one of the most widely experienced health
problems in the United States and the world. It is the second most frequent condition, after
the common cold, for which people see a doctor or lose days from work.
In this part of the study, we will treat patients with spinal stenosis (a narrowing of
spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) with
a type of surgery known as posterior decompressive laminectomy or with nonsurgical methods.
This study does not cover the cost of treatment.
Low back pain is considered one of the most widely experienced health problems in the U.S.
and the world. It is the second most frequent condition, after the common cold, for which
patients 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 condition appear to determine the rates of surgery. Despite these trends, there
is little evidence proving the effectiveness of these therapies over non-surgical
management.
This study will use the National Spine Network to conduct 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 second diagnostic group. The study will compare the most commonly
used standard surgical treatments to the most commonly used standard nonsurgical 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 health care use. We anticipate that we will enroll and
randomly allocate a total of 370 study participants in this arm of the trial. We will track
an additional observational cohort to assess health and resource outcomes. 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 nonsurgical interventions for IDH, SpS, and DS. The
results of this trial will provide, for the first time, scientific evidence as to the
relative effectiveness of surgical versus nonsurgical treatment for these three most
commonly diagnosed lumbar spine conditions.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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