Lumbar Intervertebral Disc Herniation Clinical Trial
Official title:
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.
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