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

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ClinicalTrials.gov Identifier: NCT01756196
Recruitment Status : Completed
First Posted : December 25, 2012
Last Update Posted : December 25, 2012
Sponsor:
Information provided by (Responsible Party):
Guen Young Lee, Seoul National University Bundang Hospital

Brief Summary:
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 or disease Intervention/treatment
Incidence and Types of Systemic Reactions Occurring After Spinal Steroid Injection in a Large Population Drug: Spinal 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.

Study Type : Observational [Patient Registry]
Actual Enrollment : 997 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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




Primary Outcome Measures :
  1. episodes of systemic reactions after spinal steroid injection [ Time Frame: 2 weeks ]
    Evaluation of episodes of systemic reactions after spinal steroid injection



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Ages Eligible for Study:   13 Years to 94 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: December 25, 2012
Last Verified: December 2012

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