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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00000410
First received: November 3, 1999
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Herniated Disc
Low Back Pain
Procedure: Diskectomy
Procedure: Non-surgical treatments
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Intervertebral Disc Herniation (IDH)

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction with treatment [ Time Frame: Baseline, 6 wks, 3 mos, Annually thereafter ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • resource utilization [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ] [ Designated as safety issue: No ]
  • cost [ Time Frame: Baseline, 6 wks, 3 and 6 mos, Annually thereafter ] [ Designated as safety issue: No ]

Enrollment: 501
Study Start Date: March 2000
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000410

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

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00000410     History of Changes
Other Study ID Numbers: U01 AR45444 NIAMS-004C, U01AR045444
Study First Received: November 3, 1999
Last Updated: August 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Dartmouth-Hitchcock Medical Center:
Intervertebral disc herniation (IDH)
Stenosis with degenerative spondylolisthesis (DS)
Spinal stenosis (SpS)
Low back pain (LBP)
Leg pain
Surgical therapy
Non-surgical therapy
Randomized study
Multicenter
MRI

Additional relevant MeSH terms:
Back Pain
Hernia
Intervertebral Disc Displacement
Low Back Pain
Bone Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Pathological Conditions, Anatomical
Signs and Symptoms
Spinal Diseases

ClinicalTrials.gov processed this record on April 23, 2015