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

NCT00000410 | Completed Phase 4 DMC

• 2 other identifiers: U01 AR45444 NIAMS-004CU01AR045444
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Herniated Disc; Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Patient satisfaction with treatment

  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

  Baseline, 1 yr, 4 yr

• resource utilization

  Baseline, 6 wks, 3 and 6 mos, Annually thereafter

• cost

  Baseline, 6 wks, 3 and 6 mos, Annually thereafter

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Diskectomy

Procedure: Diskectomy; Procedure: Non-surgical treatments

Non-surgical intervention

ACTIVE COMPARATOR

Non-surgical treatments

Procedure: Non-surgical treatments

Interventions

Diskectomy PROCEDURE

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.

Surgery

Non-surgical treatments PROCEDURE

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

Non-surgical intervention; Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator
• Office of Research on Women's Health (ORWH): collaborator

Study Sites (13)

Kaiser Permanente Spine Care Program

Oakland, California, 94612, United States

Location

University of California, San Francisco

San Francisco, California, 94143-0728, United States

Location

The Emory Clinic, Emory University

Decatur, Georgia, 30033, United States

Location

Rush-Presbyterian, St. Luke's Medical Center

Chicago, Illinois, 60612-3833, United States

Location

Maine Spine & Rehabilitation

Scarborough, Maine, 04074, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073-9952, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Nebraska Foundation for Spinal Research

Omaha, Nebraska, 68154-4438, United States

Location

Dartmouth-Hitchcock Medical Center - Spine Center

Lebanon, New Hampshire, 03756, United States

Location

New York University, The Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Rothman Institute at Thomas Jefferson Hospital

Philadelphia, Pennsylvania, 19107-4216, United States

Location

Related Publications (13)

• 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.

  PMID: 12065987 BACKGROUND

• 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.

  PMID: 10787504 BACKGROUND

• 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.

  PMID: 14520044 BACKGROUND

• Phillips FM, An H, Kang JD, Boden SD, Weinstein J. Biologic treatment for intervertebral disc degeneration: summary statement. Spine (Phila Pa 1976). 2003 Aug 1;28(15 Suppl):S99. doi: 10.1097/01.BRS.0000076906.82028.03.

  PMID: 12897482 BACKGROUND

• 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.

  PMID: 12642770 BACKGROUND

• Weinstein JN, Lurie JD, Tosteson TD, Skinner JS, Hanscom B, Tosteson AN, Herkowitz H, Fischgrund J, Cammisa FP, Albert T, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA. 2006 Nov 22;296(20):2451-9. doi: 10.1001/jama.296.20.2451.

  PMID: 17119141 RESULT

• Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50. doi: 10.1001/jama.296.20.2441.

  PMID: 17119140 RESULT

• Weinstein JN, Lurie JD, Tosteson TD, Tosteson AN, Blood EA, Abdu WA, Herkowitz H, Hilibrand A, Albert T, Fischgrund J. Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Dec 1;33(25):2789-800. doi: 10.1097/BRS.0b013e31818ed8f4.

  PMID: 19018250 RESULT

• Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. doi: 10.1097/brs.0b013e318182e390.

  PMID: 18777603 RESULT

• 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.

  PMID: 22048651 RESULT

• Desai A, Bekelis K, Ball PA, Lurie J, Mirza SK, Tosteson TD, Zhao W, Weinstein JN. Spine patient outcomes research trial: do outcomes vary across centers for surgery for lumbar disc herniation? Neurosurgery. 2012 Oct;71(4):833-42. doi: 10.1227/NEU.0b013e31826772cb.

  PMID: 22791040 DERIVED

• Desai A, Ball PA, Bekelis K, Lurie J, Mirza SK, Tosteson TD, Zhao W, Weinstein JN. Surgery for lumbar degenerative spondylolisthesis in Spine Patient Outcomes Research Trial: does incidental durotomy affect outcome? Spine (Phila Pa 1976). 2012 Mar 1;37(5):406-13. doi: 10.1097/BRS.0b013e3182349bc5.

  PMID: 21971123 DERIVED

• Olson PR, Lurie JD, Frymoyer J, Walsh T, Zhao W, Morgan TS, Abdu WA, Weinstein JN. Lumbar disc herniation in the Spine Patient Outcomes Research Trial: does educational attainment impact outcome? Spine (Phila Pa 1976). 2011 Dec 15;36(26):2324-32. doi: 10.1097/BRS.0b013e31820bfb9a.

  PMID: 21311402 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement; Low Back Pain; Spinal Stenosis

Interventions

Diskectomy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative

Study Officials

• James N. Weinstein, DO, MS

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: March 1, 2000
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

US (13)