Lumbar Disc Herniation Outcome Measures

This study has been terminated.
(Slow/low enrollment)
Sponsor:
Information provided by (Responsible Party):
William Lavelle, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01041391
First received: November 18, 2009
Last updated: September 6, 2013
Last verified: September 2013

November 18, 2009
September 6, 2013
May 2009
December 2020   (final data collection date for primary outcome measure)
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
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) and generally at 2 & 6 weeks, 3, 6, & 12 mos post op. However, should a subject return for any visit, they will be asked to complete the questionnaires and the data will be added to the st ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01041391 on ClinicalTrials.gov Archive Site
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Lumbar Disc Herniation Outcome Measures
Lumbar Disc Herniation Outcome Measures-Surgical Versus Non-Operative Treatment

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients in the SUNY Upstate Orthopedic Surgery department

Lumbar Intervertebral Disc Herniation
Procedure: Discectomy-lumbar spine
Lumbar intervertebral discectomy performed on patients with herniated disc that chose to have surgical intervention
  • Surgical treatment for Lumbar disc herniation
    Patients who had or will have surgery for Lumbar disc herniation
    Intervention: Procedure: Discectomy-lumbar spine
  • Non-surgical treatment for Lumbar disc herniation
    Patients that have chosen conservative treatment for lumbar disc herniation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
December 2020
December 2020   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01041391
5812-LSS
No
William Lavelle, State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
Not Provided
Principal Investigator: William F. Lavelle, MD State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP