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Lumbar Disc Herniation Outcome Measures

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01041391
First received: November 18, 2009
Last updated: July 20, 2011
Last verified: August 2010
History of Changes
  Purpose

This study is being conducted to examine outcome measurements on patients who undergo surgery to removed a damage lumbar spine disc versus those that chose not to have surgery. These outcomes are based on patient responses to quality of life and pain questionnaires.


Condition Intervention
Lumbar Intervertebral Disc Herniation
 Procedure: Discectomy-lumbar spine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lumbar Disc Herniation Outcome Measures-Surgical Versus Non-Operative Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • The efficacy of surgery for lumbar intervertebral disc herniation vs non-operative treatment, using self-report questionnaires Short form 36, Visual Analog Scale and Oswestry Disability Index at baseline (prior to surgery) and all subsequent visits [ Time Frame: baseline (prior to surgery) & 12 mos post op. ] [ Designated as safety issue: No ]
    data will be collected at each office visit, regardless of time point


Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: December 2020
Groups/Cohorts Assigned Interventions
Surgical treatment for Lumbar disc herniation
Patients who had or will have surgery for Lumbar disc herniation
 Procedure: Discectomy-lumbar spine
Lumbar intervertebral discectomy performed on patients with herniated disc that chose to have surgical intervention
Non-surgical treatment for Lumbar disc herniation
Patients that have chosen conservative treatment for lumbar disc herniation

Detailed Description:

Lumbar discectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to non-operative care remains controversial.

Several studies have compared surgical and non-operative treatment of patients with herniated discs, but baseline differences between treatment groups, small sample sizes, or lack of validated outcome measures in these studies limit evident-based conclusions regarding optimal treatment.

There is increasing emphasis on the use of health-related quality of life(QOL)outcome measures to determine the efficacy of treatment, particularly for diseases that are not life threatening but affect the patient's QOL. In the treatment of lumbar disc herniation, the Medical Outcomes Study Short Form (SF-36), Oswestry Disability Index (ODI) and Visual Analog Scale (VAS), are validated and common scales that are used to measure treatment outcomes.

Information is routinely collected on activity limitations in the course of the doctor's assessment of the patient, however, the data may not always be collected in a standardized format that yields measurement with known reliability and validity. Standardized self-report questionnaires provide a convenient method of collecting and synthesizing a large amount of information on the pain, activity limitation and general health status of each patient.

The objective of this prospective study is to evaluate the efficacy of surgery for lumbar intervertebral disc herniations using the SF-36, ODI and VAS as primary outcome measures. Patients experiencing acute or chronic lumbar spine pain in the Orthopedic practice will be given a choice to participate in this study. On patient's who wish to participate, the data will be collected and entered into the REMARK OMR 7 database, and evaluated for outcomes.

This study is for current patients in the Upstate Orthopedic office.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in the SUNY Upstate Orthopedic Surgery department

Criteria

Inclusion Criteria:

  • Must be at least 18 years of age and no older than 90 years of age
  • Must have diagnosis of Lumbar disc herniation
  • Must be able to understand English, and willing to consent to data collection
  • Must be a current patient in our practice

Exclusion Criteria:

  • Prisoner
  • Unable to complete questionnaires
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041391

Locations
United States, New York
SUNY Upstate Medical University-Department of Orthopedics
Syracuse, New York, United States, 13202
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: William F. Lavelle, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: William F. Lavelle, MD, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT01041391     History of Changes
Other Study ID Numbers: 5812-LSS
Study First Received: November 18, 2009
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Surgical intervention vs Non-Surgical intervention

Additional relevant MeSH terms:
Hernia
Intervertebral Disk Displacement
Pathological Conditions, Anatomical
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 22, 2013