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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02939482
Date of registration: 15/10/2016
Prospective Registration: No
Primary sponsor: Navamindradhiraj University
Public title: A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection
Scientific title: A Prospective Study Comparison of Clinical Outcome After Different Rate Infusion in Caudal Epidural Steroid Injection
Date of first enrolment: October 1, 2016
Target sample size: 112
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02939482
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Thailand
Contacts
Name:     Satit Thiengwittayaporn, M.D.
Address: 
Telephone:
Email:
Affiliation:  Navamindradhiraj University
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Radiculopathy
Spinal Stenosis
Lumbosacral Spondylosis
Intervention(s)
Drug: Triamcinolone Acetonide and normal saline solution
Primary Outcome(s)
Change from baseline Patient satisfaction scale at 2, 6, 12 weeks [Time Frame: 2, 6, 12 weeks]
Change from baseline Standing tolerance test at 2, 6, 12 weeks [Time Frame: 2, 6, 12 weeks]
Change from baseline Visual Analogue Scale at 2, 6, 12 weeks [Time Frame: 2, 6, 12 weeks]
Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks [Time Frame: 2, 6, 12 weeks]
Change from baseline Walking tolerance test at 2, 6, 12 weeks [Time Frame: 2, 6, 12 weeks]
Secondary Outcome(s)
Complication of Caudal Epidural Steroid Injection [Time Frame: 2, 6, 12 weeks]
Secondary ID(s)
COA 74/2559
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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