Lumbar Disc Herniation Outcome Measures



Status:Terminated
Conditions:Orthopedic, Gastrointestinal
Therapuetic Areas:Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 90
Updated:9/8/2018
Start Date:May 2009
End Date:January 13, 2013

Use our guide to learn which trials are right for you!

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.

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
We found this trial at
1
site
?
mi
from
Syracuse, NY
Click here to add this to my saved trials