Incidence of Various Types of Systemic Reactions Related to Spinal Steroid Injection: A Prospective Study

December 19, 2012 updated by: Guen Young Lee, Seoul National University Bundang Hospital

Prospective Observational Study of Evaluate the Incidence and Types of Systemic Reactions After Spinal Steroid Injections

Many systemic reactions occur commonly after spinal steroid injections, especially in patients, and may be associated with underlying disease, such as hypertension and diabetes mellitus, as well as steroid dose and repetition of spinal steroid injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluate the incidence and types of systemic reactions after spinal steroid injections and to investigate the association of spinal steroid injection with patient demographics, history of previous injections, type and dose of steroid, and method and site of previous and current injections.

Study Type

Observational

Enrollment (Actual)

997

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

  • Korea, Republic of
    • Bundang
      • Seoung Nam, Bundang, Korea, Republic of, 463-802
        • Seoul National University Bundang Hospital

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

13 years to 94 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients receiving the injection were informed of the aim and protocol of this study and the possible local and systemic reactions associated with spinal steroid injection

Description

Inclusion Criteria:

  • Indicaion of steroid injction.

Exclusion Criteria:

  • Contraindiation of steroid injction.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Steroid Injection
Reactions associated with spinal steroid injection
Drug: Spinal Steroid Injection
Steroid Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
episodes of systemic reactions after spinal steroid injection
Time Frame: 2 weeks
Evaluation of episodes of systemic reactions after spinal steroid injection
2 weeks

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimate)

December 25, 2012

Study Record Updates

Last Update Posted (Estimate)

December 25, 2012

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B-1008/016-004

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.

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