Lumbar Disc Herniation Outcome Measures

Lumbar Intervertebral Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01041391
• Other study ID #: 5812-LSS
• Status: Terminated
• Start date: May 2009
• Est. completion date: January 13, 2013

Study information

• Verified date: September 2018
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: January 13, 2013
• Est. primary completion date: January 13, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Lumbar Intervertebral Disc Herniation

Intervention

Procedure:
• Discectomy-lumbar spine
Lumbar intervertebral discectomy performed on patients with herniated disc that chose to have surgical intervention

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University-Department of Orthopedics	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.