Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02939482 |
Date of registration:
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15/10/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection
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Scientific title:
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A Prospective Study Comparison of Clinical Outcome After Different Rate Infusion in Caudal Epidural Steroid Injection |
Date of first enrolment:
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October 1, 2016 |
Target sample size:
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112 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02939482 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Satit Thiengwittayaporn, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Navamindradhiraj University |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Radiculopathy
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Spinal Stenosis
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Lumbosacral Spondylosis
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Intervention(s)
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Drug: Triamcinolone Acetonide and normal saline solution
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Primary Outcome(s)
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Change from baseline Patient satisfaction scale at 2, 6, 12 weeks
[Time Frame: 2, 6, 12 weeks]
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Change from baseline Standing tolerance test at 2, 6, 12 weeks
[Time Frame: 2, 6, 12 weeks]
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Change from baseline Visual Analogue Scale at 2, 6, 12 weeks
[Time Frame: 2, 6, 12 weeks]
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Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks
[Time Frame: 2, 6, 12 weeks]
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Change from baseline Walking tolerance test at 2, 6, 12 weeks
[Time Frame: 2, 6, 12 weeks]
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Secondary Outcome(s)
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Complication of Caudal Epidural Steroid Injection
[Time Frame: 2, 6, 12 weeks]
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Secondary ID(s)
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COA 74/2559
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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