Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000410
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
1999-11-03
Brief Title:
Spine Patient Outcomes Research Trial SPORT - Intervertebral Disc Herniation
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Spine Patient Outcomes Research Trial SPORT A Multicenter Randomized Trial for Intervertebral Disc Herniation IDH
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPORT
Brief Summary:
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
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:
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 US 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01AR045444 | NIH | None | httpsreporternihgovquickSearchU01AR045444 |