Lumbar Disc Herniation Outcome Measures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01041391
Recruitment Status : Terminated (Slow/low enrollment)
First Posted : December 31, 2009
Last Update Posted : September 9, 2013
Information provided by (Responsible Party):
William Lavelle, State University of New York - Upstate Medical University

Brief Summary:
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 or disease Intervention/treatment
Lumbar Intervertebral Disc Herniation Procedure: Discectomy-lumbar spine

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.

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lumbar Disc Herniation Outcome Measures-Surgical Versus Non-Operative Treatment
Study Start Date : May 2009
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]
    data will be collected at each office visit, regardless of time point

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in the SUNY Upstate Orthopedic Surgery department

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01041391

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
Principal Investigator: William F. Lavelle, MD State University of New York - Upstate Medical University

Responsible Party: William Lavelle, Associate Professor, State University of New York - Upstate Medical University Identifier: NCT01041391     History of Changes
Other Study ID Numbers: 5812-LSS
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 2013

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

Additional relevant MeSH terms:
Pathological Conditions, Anatomical