IPM Procedures With or Without Fluoroscopy: Outcome Comparison

October 20, 2015 updated by: Pain Management Center of Paducah

Comparison of Outcomes of Interventional Pain Management Procedures Performed With or Without Fluoroscopy: A Retrospective Analysis

To determine clinically significant improvement in the patients undergoing procedures under fluoroscopy.

To evaluate and compare the adverse event profile in both groups

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Procedure: Fluoroscopy

Detailed Description

For the target delivery of injectate, it is believed that fluoroscopy is mandatory. However, there is a view among some professionals that a procedure may be performed without fluoroscopy as effectively as under fluoroscopy. The outcomes among the two groups of patients have not been studied

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Kentucky
  - Paducah, Kentucky, United States, 42003
    - Ambulatory Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

currently enrolled patients

Description

Inclusion Criteria:

Patients who have undergone the following procedures:

Cervical facet joint nerve blocks, thoracic facet joint nerve blocks, lumbar facet joint nerve blocks, lumbar interlaminar epidural steroid injections, cervical Interlaminar epidural steroid injections

During 1998 to 2001 and 2004 to 2005

Exclusion Criteria: Non-availability of appropriate data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To demonstrate clinically significant improvement in the patients undergoing procedures under fluoroscopy.
To evaluate and compare the adverse event profile in both groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pain Management Center of Paducah

Investigators

Principal Investigator: Laxmaiah Manchikanti, MD, Ambulatory Surgery Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Study Completion

May 1, 2004

Study Registration Dates

First Submitted

September 1, 2006

First Submitted That Met QC Criteria

September 1, 2006

First Posted (Estimate)

September 4, 2006

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

protocol 13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.