Clinical trial NCT00000410: Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation
Official title: Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Intervertebral Disc Herniation (IDH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herniated Disc
Low Back Pain
Keywords: 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
MRI
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Institute for Occupational Safety and Health (NIOSH/CDC)
name: Office of Research on Women's Health (ORWH)
First posted: 1999-11-04
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in health-related quality of life as measured by the SF-36 health status questionnaire
timeFrame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Secondary outcomes:
measure: Patient satisfaction with treatment
timeFrame: Baseline, 6 wks, 3 mos, Annually thereafter
measure: utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness
timeFrame: Baseline, 1 yr, 4 yr
measure: resource utilization
timeFrame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
measure: cost
timeFrame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Spine Care Program
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Decatur
country: United States
facility: The Emory Clinic, Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush-Presbyterian, St. Luke's Medical Center
state: Illinois
city: Scarborough
country: United States
facility: Maine Spine & Rehabilitation
state: Maine
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: Nebraska Foundation for Spinal Research
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center - Spine Center
state: New Hampshire
city: New York
country: United States
facility: New York University, The Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Philadelphia
country: United States
facility: Rothman Institute at Thomas Jefferson Hospital
state: Pennsylvania
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: James N. Weinstein, DO, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birkmeyer NJ, Weinstein JN, Tosteson AN, Tosteson TD, Skinner JS, Lurie JD, Deyo R, Wennberg JE. Design of the Spine Patient outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2002 Jun 15;27(12):1361-72. doi: 10.1097/00007632-200206150-00020.
citation: Weinstein JN, Brown PW, Hanscom B, Walsh T, Nelson EC. Designing an ambulatory clinical practice for outcomes improvement: from vision to reality--the Spine Center at Dartmouth-Hitchcock, year one. Qual Manag Health Care. 2000 Winter;8(2):1-20. doi: 10.1097/00019514-200008020-00003.
citation: Fanciullo GJ, Hanscom B, Weinstein JN, Chawarski MC, Jamison RN, Baird JC. Cluster analysis classification of SF-36 profiles for patients with spinal pain. Spine (Phila Pa 1976). 2003 Oct 1;28(19):2276-82. doi: 10.1097/01.BRS.0000084880.33281.EB.
citation: Phillips FM, An H, Kang JD, Boden SD, Weinstein J. Biologic treatment for intervertebral disc degeneration: summary statement. Spine (Phila Pa 1976). 2003 Aug 1;28(15 Suppl):S99. doi: 10.1097/01.BRS.0000076906.82028.03.
citation: Walsh TL, Hanscom B, Lurie JD, Weinstein JN. Is a condition-specific instrument for patients with low back pain/leg symptoms really necessary? The responsiveness of the Oswestry Disability Index, MODEMS, and the SF-36. Spine (Phila Pa 1976). 2003 Mar 15;28(6):607-15. doi: 10.1097/01.BRS.0000050654.97387.DF.
citation: Weinstein JN, Lurie JD, Tosteson TD, Skinner JS, Hanscom B, Tosteson AN, Herkowitz H, Fischgrund J, Cammisa FP, Albert T, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA. 2006 Nov 22;296(20):2451-9. doi: 10.1001/jama.296.20.2451.
citation: Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50. doi: 10.1001/jama.296.20.2441.
citation: Weinstein JN, Lurie JD, Tosteson TD, Tosteson AN, Blood EA, Abdu WA, Herkowitz H, Hilibrand A, Albert T, Fischgrund J. Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Dec 1;33(25):2789-800. doi: 10.1097/BRS.0b013e31818ed8f4.
citation: Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. doi: 10.1097/brs.0b013e318182e390.
citation: Tosteson AN, Tosteson TD, Lurie JD, Abdu W, Herkowitz H, Andersson G, Albert T, Bridwell K, Zhao W, Grove MR, Weinstein MC, Weinstein JN. Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2061-8. doi: 10.1097/BRS.0b013e318235457b.
citation: Desai A, Bekelis K, Ball PA, Lurie J, Mirza SK, Tosteson TD, Zhao W, Weinstein JN. Spine patient outcomes research trial: do outcomes vary across centers for surgery for lumbar disc herniation? Neurosurgery. 2012 Oct;71(4):833-42. doi: 10.1227/NEU.0b013e31826772cb.
citation: Desai A, Ball PA, Bekelis K, Lurie J, Mirza SK, Tosteson TD, Zhao W, Weinstein JN. Surgery for lumbar degenerative spondylolisthesis in Spine Patient Outcomes Research Trial: does incidental durotomy affect outcome? Spine (Phila Pa 1976). 2012 Mar 1;37(5):406-13. doi: 10.1097/BRS.0b013e3182349bc5.
citation: Olson PR, Lurie JD, Frymoyer J, Walsh T, Zhao W, Morgan TS, Abdu WA, Weinstein JN. Lumbar disc herniation in the Spine Patient Outcomes Research Trial: does educational attainment impact outcome? Spine (Phila Pa 1976). 2011 Dec 15;36(26):2324-32. doi: 10.1097/BRS.0b013e31820bfb9a.