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A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection

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ClinicalTrials.gov Identifier: NCT02939482
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Satit Thiengwittayaporn, Navamindradhiraj University

Brief Summary:
The purpose of this study is to determine the effects of different rates of Caudal Epidural Steroid Injection (CESI) on clinical outcomes of the patients.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Lumbosacral Spondylosis Radiculopathy Drug: Triamcinolone Acetonide and normal saline solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study Comparison of Clinical Outcome After Different Rate Infusion in Caudal Epidural Steroid Injection
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : August 2, 2018
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1: 40 ml/min
Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 0.5 min
Drug: Triamcinolone Acetonide and normal saline solution
80 mg/2 ml Triamcinolone Acetonide and 18 ml normal saline solution

Experimental: Group 2: 20 ml/min
Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 1 min
Drug: Triamcinolone Acetonide and normal saline solution
80 mg/2 ml Triamcinolone Acetonide and 18 ml normal saline solution




Primary Outcome Measures :
  1. Change from baseline Visual Analogue Scale at 2, 6, 12 weeks [ Time Frame: 2, 6, 12 weeks ]
  2. Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks [ Time Frame: 2, 6, 12 weeks ]
  3. Change from baseline Standing tolerance test at 2, 6, 12 weeks [ Time Frame: 2, 6, 12 weeks ]
  4. Change from baseline Walking tolerance test at 2, 6, 12 weeks [ Time Frame: 2, 6, 12 weeks ]
  5. Change from baseline Patient satisfaction scale at 2, 6, 12 weeks [ Time Frame: 2, 6, 12 weeks ]

Secondary Outcome Measures :
  1. Complication of Caudal Epidural Steroid Injection [ Time Frame: 2, 6, 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lumbosacral spinal stenosis with radiculopathy
  • no improvement after conservative treatment for 6 weeks

Exclusion Criteria:

  • previous CESI or spinal surgery
  • skin infection at injection site
  • uncontrolled diabetes mellitus
  • abnormal coagulogram
  • vertebral fracture
  • previous history of allergy to steroid or anesthetic agent

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): NCT02939482


Locations
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Thailand
Navamindradhiraj University
Dusit, Bangkok, Thailand, 10300
Sponsors and Collaborators
Navamindradhiraj University
Investigators
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Principal Investigator: Satit Thiengwittayaporn, M.D. Navamindradhiraj University

Publications of Results:
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Responsible Party: Satit Thiengwittayaporn, Associate Professor, Navamindradhiraj University
ClinicalTrials.gov Identifier: NCT02939482     History of Changes
Other Study ID Numbers: COA 74/2559
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Spinal Stenosis
Radiculopathy
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pharmaceutical Solutions
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action