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The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Medial vs Lateral in Anteroposterior View

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ClinicalTrials.gov Identifier: NCT02867046
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE August 7, 2016
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date May 18, 2018
Actual Study Start Date  ICMJE July 29, 2016
Actual Primary Completion Date November 28, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • the incidence of intravascular injection in the medial approach group in S1 foramen [ Time Frame: 5 seconds after injection of contrast media via block needle. ]
  • the incidence of intravascular injection in the lateral approach group in S1 foramen [ Time Frame: 5 seconds after injection of contrast media via block needle. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02867046 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Medial vs Lateral in Anteroposterior View
Official Title  ICMJE Not Provided
Brief Summary Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial approach and method using lateral approach in anteroposterior view, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Lumbosacral Radicular Pain
Intervention  ICMJE Drug: S1 transforaminal epidural steroid(dexamethasone) injection

medial approach group (n=85): check intravascular injection while performing S1 transforaminal epidural steroid(dexamethasone) injection in medial side of S1 foramen under fluoroscopy

lateral approach group (n=85): same as medial approach group except using lateral side of S1 foramen

Study Arms  ICMJE
  • Experimental: medial approach group
    Intervention: Drug: S1 transforaminal epidural steroid(dexamethasone) injection
  • Active Comparator: lateral approach group
    Intervention: Drug: S1 transforaminal epidural steroid(dexamethasone) injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2018)
165
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)
170
Actual Study Completion Date  ICMJE November 28, 2016
Actual Primary Completion Date November 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at pain management clinic

Exclusion Criteria:

  1. pregnancy
  2. coagulopathy
  3. systemic infection
  4. any active infection at the injection site
  5. history of allergy to contrast media, local anesthetics, corticosteroid
  6. patients unable to communicate or patients with cognitive dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867046
Other Study ID Numbers  ICMJE 4-2016-0442
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP