Spine Patient Outcomes Research Trial (SPORT): Spinal Stenosis

NCT ID: NCT00000411

Last Updated: 2015-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 289 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31
• Study Completion Date: 2015-04-30

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.

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.

Conditions

Spinal Stenosis; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery

Decompressive laminectomy

Group Type: ACTIVE_COMPARATOR

Decompressive laminectomy

Intervention Type: PROCEDURE

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.

Non-surgical treatments

Intervention Type: OTHER

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

Non-surgical treatments

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

Group Type: ACTIVE_COMPARATOR

Non-surgical treatments

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: PROCEDURE

Non-surgical treatments

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

National Institute for Occupational Safety and Health (NIOSH/CDC)

FED

Sponsor Role: collaborator

Office of Research on Women's Health (ORWH)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James N. Weinstein, DO, MS

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Kaiser Permanente Spine Care Program

Oakland, California, United States

University of California, San Francisco (UCSF)

San Francisco, California, United States

Emory University, The Emory Clinic

Decatur, Georgia, United States

Rush-Presbyterian, St. Luke's Medical Center

Chicago, Illinois, United States

Maine Spine & Rehabilitation

Scarborough, Maine, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Washington University

St Louis, Missouri, United States

Nebraska Foundation for Spinal Research

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center - Spine Center

Lebanon, New Hampshire, United States

New York University, The Hospital for Joint Diseases

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

Case Western Reserve University

Cleveland, Ohio, United States

Rothman Institute at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12065987 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10787504 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14520044 (View on PubMed)

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. doi: 10.1097/01.BRS.0000049927.37696.DC.

Reference Type: BACKGROUND

PMID: 12642771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12642770 (View on PubMed)

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. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.

Reference Type: RESULT

PMID: 18287602 (View on PubMed)

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 Outcomes Research Trial. Spine (Phila Pa 1976). 2010 Jun 15;35(14):1329-38. doi: 10.1097/BRS.0b013e3181e0f04d.

Reference Type: RESULT

PMID: 20453723 (View on PubMed)

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 spondylolisthesis: cost-effectiveness after 2 years. Ann Intern Med. 2008 Dec 16;149(12):845-53. doi: 10.7326/0003-4819-149-12-200812160-00003.

Reference Type: RESULT

PMID: 19075203 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22048651 (View on PubMed)

Desai A, Ball PA, Bekelis K, Lurie J, Mirza SK, Tosteson TD, Weinstein JN. SPORT: Does incidental durotomy affect longterm outcomes in cases of spinal stenosis? Neurosurgery. 2015 Mar;76 Suppl 1(0 1):S57-63; discussion S63. doi: 10.1227/01.neu.0000462078.58454.f4.

Reference Type: DERIVED

PMID: 25692369 (View on PubMed)

Desai A, Ball PA, Bekelis K, Lurie J, Mirza SK, Tosteson TD, Weinstein JN. SPORT: does incidental durotomy affect long-term outcomes in cases of spinal stenosis? Neurosurgery. 2011 Jul;69(1):38-44; discussion 44. doi: 10.1227/NEU.0b013e3182134171.

Reference Type: DERIVED

PMID: 21358354 (View on PubMed)

Other Identifiers

U01AR045444

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01 AR45444 NIAMS-004B

Identifier Type: -

Identifier Source: org_study_id