Spine Patient Outcomes Research Trial (SPORT): Spinal Stenosis

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00000411

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), National Institute for Occupational Safety and Health (NIOSH/CDC) (U.S. Fed), Office of Research on Women's Health (ORWH) (NIH)

289

Enrollment

Locations

Arms

181

Duration (Months)

22.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Stenosis Low Back Pain	Procedure: Decompressive laminectomy Other: Non-surgical treatments	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

289 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Spine Patient Outcomes Research Trial (SPORT): A Multicenter Trial for Spinal Stenosis (SpS)

Study Start Date :

Mar 1, 2000

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Surgery Decompressive laminectomy	Procedure: Decompressive laminectomy Removal of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosis. Other: Non-surgical treatments Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated
Active Comparator: Non-surgical treatments Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated	Other: Non-surgical treatments Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated

Arm

Intervention/Treatment

Active Comparator: Surgery

Decompressive laminectomy

Procedure: Decompressive laminectomy

Removal of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosis.

Other: Non-surgical treatments

Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated

Active Comparator: Non-surgical treatments

Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated

Other: Non-surgical treatments

Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Duration of Symptoms: 12 or more weeks.
Treatments tried: Nonsteroidal anti-inflammatory medical therapy and physical therapy.
Surgical Screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms.
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 that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months.
Possible pregnancy.
Active malignancy: Patients with a history of any invasive malignancy (except nonmelanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any 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 neurologic deficit (usually requiring urgent surgery).
Unavailability for followup (planning to move, no telephone, etc.) or inability to complete data surveys.
Symptoms less than 12 weeks.
Patient currently enrolled in any experimental "spine related" study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Spine Care Program	Oakland	California	United States	94612
2	University of California, San Francisco (UCSF)	San Francisco	California	United States	94143-0728
3	Emory University, The Emory Clinic	Decatur	Georgia	United States	30033
4	Rush-Presbyterian, St. Luke's Medical Center	Chicago	Illinois	United States	60612-3833
5	Maine Spine & Rehabilitation	Scarborough	Maine	United States	04074
6	William Beaumont Hospital	Royal Oak	Michigan	United States	48073-9952
7	Washington University	St. Louis	Missouri	United States	63110
8	Nebraska Foundation for Spinal Research	Omaha	Nebraska	United States	68154-4438
9	Dartmouth-Hitchcock Medical Center - Spine Center	Lebanon	New Hampshire	United States	03756
10	New York University, The Hospital for Joint Diseases	New York	New York	United States	10003
11	Hospital for Special Surgery	New York	New York	United States	10021
12	Case Western Reserve University	Cleveland	Ohio	United States	44106
13	Rothman Institute at Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107-4216