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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guen Young Lee, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01756196
First received: December 19, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Incidence and Types of Systemic Reactions Occurring After Spinal Steroid Injection in a Large Population
 Drug: Spinal Steroid Injection

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Prospective Observational Study of Evaluate the Incidence and Types of Systemic Reactions After Spinal Steroid Injections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • episodes of systemic reactions after spinal steroid injection [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Evaluation of episodes of systemic reactions after spinal steroid injection


Enrollment: 997
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Steroid Injection
Reactions associated with spinal steroid injection
 Drug: Spinal Steroid Injection
Steroid Injection

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.

  Eligibility

Ages Eligible for Study:   13 Years to 94 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

  • Indicaion of steroid injction.

Exclusion Criteria:

  • Contraindiation of steroid injction.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756196

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seoung Nam, Bundang, Korea, Republic of, 463-802
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Guen Young Lee, Associate Professor, MD, PhD, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01756196     History of Changes
Other Study ID Numbers: B-1008/016-004
Study First Received: December 19, 2012
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
Spinal injection; Steroid; Systemic reaction; Complication; Side effect; Diabetes mellitus; Hypertension; Risk factor

ClinicalTrials.gov processed this record on May 23, 2013