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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000411
Other study ID # U01 AR45444 NIAMS-004B
Secondary ID U01AR045444
Status Completed
Phase Phase 4
First received November 3, 1999
Last updated August 3, 2015
Start date March 2000
Est. completion date April 2015

Study information

Verified date August 2015
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 289
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Rush-Presbyterian, St. Luke's Medical Center Chicago Illinois
United States Case Western Reserve University Cleveland Ohio
United States Emory University, The Emory Clinic Decatur Georgia
United States Dartmouth-Hitchcock Medical Center - Spine Center Lebanon New Hampshire
United States Hospital for Special Surgery New York New York
United States New York University, The Hospital for Joint Diseases New York New York
United States Kaiser Permanente Spine Care Program Oakland California
United States Nebraska Foundation for Spinal Research Omaha Nebraska
United States Rothman Institute at Thomas Jefferson University Philadelphia Pennsylvania
United States William Beaumont Hospital Royal Oak Michigan
United States University of California, San Francisco (UCSF) San Francisco California
United States Maine Spine & Rehabilitation Scarborough Maine
United States Washington University St. Louis Missouri

Sponsors (4)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center National Institute for Occupational Safety and Health (NIOSH/CDC), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Research on Women's Health (ORWH)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View Citation

Lurie JD, Birkmeyer NJ, Weinstein JN. Rates of advanced spinal imaging and spine surgery. Spine (Phila Pa 1976). 2003 Mar 15;28(6):616-20. — View Citation

Tosteson AN, Lurie JD, Tosteson TD, Skinner JS, Herkowitz H, Albert T, Boden SD, Bridwell K, Longley M, Andersson GB, Blood EA, Grove MR, Weinstein JN; SPORT Investigators. Surgical treatment of spinal stenosis with and without degenerative spondylolisthe — View 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 — View 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. — View 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. Review. — View Citation

Weinstein JN, Tosteson TD, Lurie JD, Tosteson A, Blood E, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H. Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcome — View Citation

Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Patient satisfaction with treatment Baseline, 6 wks, 3 mos, Annually thereafter No
Secondary utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness Baseline, 1 yr, 4 yr No
Secondary resource utilization Baseline, 6 wks, 3 and 6 mos, Annually thereafter No
Secondary cost Baseline, 6 wks, 3 and 6 mos, Annually thereafter No
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