Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation (SPORT)

August 3, 2015 updated by: Dartmouth-Hitchcock Medical Center

Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Intervertebral Disc Herniation (IDH)

This study tests the effectiveness of different treatments for the three most commonly diagnosed lumbar (lower) spine conditions. The purpose of the study is to learn which of two commonly prescribed treatments (surgery and non-surgical therapy) works better for specific types of low back pain.

In this part of the study, people with lumbar intervertebral disc herniation (damage to the tissue between the bones of the lower spine, or backbone) will receive either discectomy (surgical removal of herniated disc material) or non-surgical treatment. This study does not cover the cost of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low back pain is considered one of the most widely experienced health problems in the United States and the world. This condition is the second most frequent condition, after the common cold, for which people 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 problem appear to determine the rates of surgery. Despite these trends, there is little evidence proving the effectiveness of these therapies over non-surgical management.

Overall, the SPORT study is 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 first diagnostic group. The study will compare the most commonly used standard surgical treatments to the most commonly used standard non-surgical 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 use of health care. In this arm of the trial, we anticipate enrolling and randomly allocating a total of 500 participants. We will track an additional observational cohort to assess health and resource outcomes (1000 participants). 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 non-surgical interventions for IDH, SpS, and DS. On the basis of the results of this trial we will, for the first time, have scientific evidence as to the relative effectiveness of surgical versus non-surgical treatment for these three most commonly diagnosed lumbar spine conditions.

Study Type

Interventional

Enrollment (Actual)

501

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Kaiser Permanente Spine Care Program
      • San Francisco, California, United States, 94143-0728
        • University of California, San Francisco
    • Georgia
      • Decatur, Georgia, United States, 30033
        • The Emory Clinic, Emory University
    • Illinois
      • Chicago, Illinois, United States, 60612-3833
        • Rush-Presbyterian, St. Luke's Medical Center
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Spine & Rehabilitation
    • Michigan
      • Royal Oak, Michigan, United States, 48073-9952
        • William Beaumont Hospital
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68154-4438
        • Nebraska Foundation for Spinal Research
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center - Spine Center
    • New York
      • New York, New York, United States, 10021
        • Hospital For Special Surgery
      • New York, New York, United States, 10003
        • New York University, The Hospital for Joint Diseases
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-4216
        • Rothman Institute at Thomas Jefferson Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Duration of symptoms: 6 or more weeks.
  • Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy.
  • Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising.
  • 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 which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months.
  • Possible pregnancy.
  • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no 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 neurological deficit (usually requiring urgent surgery).
  • Unavailability for follow-up (planning to move, no telephone, etc.) or inability to complete data surveys.
  • Symptoms less than 6 weeks.
  • Patient currently enrolled in any experimental "spine related" study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Surgery
Diskectomy
Procedure: Diskectomy
The surgeon will leave the nerve root freely mobile and undamaged following the procedure. During the procedure, the surgeon may consider using loop magnification or a microscope. The surgical incision will be midline and, after reflecting the paraspinous muscles, the interlaminar level will be identified and entered. The nerve root will be clearly identified and mobilized and then gently retracted to prepare for the discectomy. Removal of the medial border of the superior facet may, in some cases, be necessary in order to have a clear view of the lateral border of the involved nerve root. Following the clear view of the nerve root and mobilization, the IDH will be approached by making a small annular incision if necessary, the fragment of disc will then be removed (i.e., limited disc excision). A search of the canal will follow removal of the fragment, along with probing of the intervertebral-foramen for residual disc or bony pathology.
Procedure: Non-surgical treatments
Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated
ACTIVE_COMPARATOR: Non-surgical intervention
Non-surgical treatments
Procedure: Non-surgical treatments
Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 6 wks, 3 and 6 mos, Annually thereafter

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction with treatment
Time Frame: Baseline, 6 wks, 3 mos, Annually thereafter
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
Baseline, 1 yr, 4 yr
resource utilization
Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Baseline, 6 wks, 3 and 6 mos, Annually thereafter
cost
Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Baseline, 6 wks, 3 and 6 mos, Annually thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (ESTIMATE)

November 4, 1999

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01 AR45444 NIAMS-004C
  • U01AR045444 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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