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.

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) caused by degenerative spondylolisthesis (a condition in which one vertebra, or spinal bone, slips forward on another) with either surgery or nonsurgical methods. This study does not cover the cost of treatment.

Condition	Treatment or Intervention	Phase
Spondylolisthesis Spinal Stenosis Low Back Pain	Procedure: Surgery  Procedure: Non-surgical treatments	Phase III

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 nonsurgical 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 third 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, 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 300 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Judi Forman, MPH      603-653-3574    Judith.L.Forman@dartmouth.edu
Jane A. Prescott, BA      888-794-2225    Jane.A.Prescott@dartmouth.edu

California
      University of California, San Francisco (UCSF), San Francisco,  California,  94143-0728,  United States; Recruiting
      Kaiser Permanente Spine Care Program, Oakland,  California,  94612,  United States; Recruiting
Georgia
      Emory University, The Emory Clinic, Decatur,  Georgia,  30033,  United States; Recruiting
Illinois
      Rush-Presbyterian, St. Luke's Medical Center, Chicago,  Illinois,  60612-3833,  United States; Recruiting
Maine
      Maine Spine & Rehabilitation, Scarborough,  Maine,  04074,  United States; Recruiting
Michigan
      William Beaumont Hospital, Royal Oak,  Michigan,  48073-9952,  United States; Recruiting
Missouri
      Washington University, St. Louis,  Missouri,  63110,  United States; Recruiting
Nebraska
      Nebraska Foundation for Spinal Research, Omaha,  Nebraska,  68154-4438,  United States; Recruiting
New Hampshire
      Dartmouth-Hitchcock Medical Center - Spine Center, Lebanon,  New Hampshire,  03756,  United States; Recruiting
New York
      Hospital for Special Surgery, New York,  New York,  10021,  United States; Recruiting
      New York University, The Hospital for Joint Diseases, New York,  New York,  10003,  United States; Recruiting
Ohio
      Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; No longer recruiting
Pennsylvania
      Rothman Institute at Thomas Jefferson University, Philadelphia,  Pennsylvania,  19107-4216,  United States; Recruiting

Study chairs or principal investigators

James N. Weinstein, DO, MS,  Principal Investigator,  Dartmouth Medical School   

Study ID Numbers:  NIAMS-004A; U01 AR45444
Record last reviewed:  September 2004
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00000409
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08