IPM Procedures With or Without Fluoroscopy: Outcome Compa... | NCT00371618

Studies
IPM Procedures With or Without Fluoroscopy: Outcome Comparison

NCT00371618

Sponsor

Pain Management Center of Paducah

Status

Withdrawn

Last Update Posted

Oct 21, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Low Back Pain
Neck Pain

Interventions

Fluoroscopy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1998

Primary Completion Date

Not provided

Completion Date

May 2004

First Submitted Date

Sep 1, 2006

First Submission Date that Met QC Criteria

Sep 1, 2006

First Posted Date

Sep 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2015

Last Update Posted Date

Oct 21, 2015Estimated

Description Module

Brief Summary

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

To evaluate and compare the adverse event profile in both groups

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Fluoroscopy	Procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

currently enrolled patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laxmaiah Manchikanti, MD	Ambulatory Surgery Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ambulatory Surgery Center		Paducah	Kentucky	42003	United States

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain
D019547	Neck Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided