Lumbar Disc Herniation Outcome Measures

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.

Study Overview

• Status: Terminated
• Conditions: Lumbar Intervertebral Disc Herniation
• Intervention / Treatment: Procedure: Discectomy-lumbar spine

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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13202
      • SUNY Upstate Medical University-Department of Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in the SUNY Upstate Orthopedic Surgery department

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	data will be collected at each office visit, regardless of time point	baseline (prior to surgery) & 12 mos post op.

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University
• Investigators: Principal Investigator: William F. Lavelle, MD, State University of New York - Upstate Medical University

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): January 13, 2013
• Study Completion (Actual): January 13, 2013

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: December 29, 2009
• First Posted (Estimate): December 31, 2009

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Surgical intervention vs Non-Surgical intervention
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: 5812-LSS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No