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Spine Patient Outcomes Research Trial (SPORT): Spinal Stenosis

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ClinicalTrials.gov Identifier: NCT00000411
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : August 4, 2015
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute for Occupational Safety and Health (NIOSH/CDC)
Office of Research on Women's Health (ORWH)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE November 3, 1999
First Posted Date  ICMJE November 4, 1999
Last Update Posted Date August 4, 2015
Study Start Date  ICMJE March 2000
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
Changes in health-related quality of life as measured by the SF-36 health status questionnaire [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Changes in health-related quality of life as measured by the SF-36 health status questionnaire
Change History Complete list of historical versions of study NCT00000411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
  • Patient satisfaction with treatment [ Time Frame: 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 [ Time Frame: Baseline, 1 yr, 4 yr ]
  • resource utilization [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ]
  • cost [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Patient satisfaction with treatment
  • utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness
  • resource utilization
  • cost
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spine Patient Outcomes Research Trial (SPORT): Spinal Stenosis
Official Title  ICMJE Spine Patient Outcomes Research Trial (SPORT): A Multicenter Trial for Spinal Stenosis (SpS)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Stenosis
  • Low Back Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Surgery
    Decompressive laminectomy
    Interventions:
    • Procedure: Decompressive laminectomy
    • Other: Non-surgical treatments
  • Active Comparator: Non-surgical treatments
    Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated
    Intervention: Other: Non-surgical treatments
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2013)
289
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
370
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000411
Other Study ID Numbers  ICMJE U01 AR45444 NIAMS-004B
U01AR045444 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • National Institute for Occupational Safety and Health (NIOSH/CDC)
  • Office of Research on Women's Health (ORWH)
Investigators  ICMJE
Principal Investigator: James N. Weinstein, DO, MS Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP