Lumbar Disc Herniation Outcome Measures
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|ClinicalTrials.gov Identifier: NCT01041391|
Recruitment Status : Terminated (Slow/low enrollment)
First Posted : December 31, 2009
Last Update Posted : September 9, 2013
|Condition or disease||Intervention/treatment|
|Lumbar Intervertebral Disc Herniation||Procedure: Discectomy-lumbar spine|
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|
|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|
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
- 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
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 ClinicalTrials.gov identifier (NCT number): 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|