IPM Procedures With or Without Fluoroscopy: Outcome Comparison

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00371618
• Other study ID #: protocol 13
• Status: Withdrawn
• Phase: N/A
• First received: September 1, 2006
• Last updated: October 20, 2015
• Start date: January 1998
• Est. completion date: May 2004

Study information

• Verified date: October 2015
• Source: Pain Management Center of Paducah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

To evaluate and compare the adverse event profile in both groups

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Low Back Pain
• Neck Pain

Intervention

Procedure:
• Fluoroscopy

Locations

Country	Name	City	State
United States	Ambulatory Surgery Center	Paducah	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Pain Management Center of Paducah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate clinically significant improvement in the patients undergoing procedures under fluoroscopy.
Primary	To evaluate and compare the adverse event profile in both groups