Lumbar Disc Herniation Outcome Measures
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Lumbar Disc Herniation Outcome Measures-Surgical Versus Non-Operative Treatment|
- 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
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041391
|United States, New York|
|SUNY Upstate Medical University-Department of Orthopedics|
|Syracuse, New York, United States, 13202|
|Principal Investigator:||William F. Lavelle, MD||State University of New York - Upstate Medical University|