Lumbar Disc Herniation Outcome Measures

NCT01041391 | Terminated

• 1 other identifier: 5812-LSS
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Intervertebral Disc Herniation

Keywords

Surgical intervention vs Non-Surgical intervention

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Surgical treatment for Lumbar disc herniation

Patients who had or will have surgery for Lumbar disc herniation

Procedure: Discectomy-lumbar spine

Non-surgical treatment for Lumbar disc herniation

Patients that have chosen conservative treatment for lumbar disc herniation

Interventions

Discectomy-lumbar spine PROCEDURE

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

Surgical treatment for Lumbar disc herniation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the SUNY Upstate Orthopedic Surgery department

You may qualify if:

• 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

You may not qualify if:

• Prisoner
• Unable to complete questionnaires

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University-Department of Orthopedics

Syracuse, New York, 13202, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• William F. Lavelle, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: December 31, 2009
• Study Start: May 1, 2009
• Primary Completion: January 13, 2013
• Study Completion: January 13, 2013
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

US (1)