NCT01041391

Lumbar Disc Herniation Outcome Measures

Lumbar Disc Herniation Outcome Measures-Surgical Versus Non-Operative Treatment

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lumbar Intervertebral Disc Herniation

Interventions

Type	Name	Description
PROCEDURE	Discectomy-lumbar spine	Lumbar intervertebral discectomy performed on patients with herniated disc that chose to have surgical intervention

Timeline

• Start date: 2009-05-01
• Primary completion: 2013-01-13
• Completion: 2013-01-13
• First posted: 2009-12-31
• Last updated: 2018-09-06

Locations

1 site across 1 country: United States