Lumbar Disc Herniation Outcome Measures

NCT ID: NCT01041391

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-01-13

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Surgical treatment for Lumbar disc herniation

Patients who had or will have surgery for Lumbar disc herniation

Discectomy-lumbar spine

Intervention Type: PROCEDURE

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

No interventions assigned to this group

Interventions

Discectomy-lumbar spine

Lumbar intervertebral discectomy performed on patients with herniated disc that chose to have surgical intervention

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

William Lavelle

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William F. Lavelle, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

SUNY Upstate Medical University-Department of Orthopedics

Syracuse, New York, United States

Countries

United States

Other Identifiers

5812-LSS

Identifier Type: -

Identifier Source: org_study_id