NCT02939482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

1.8 years

First QC Date

October 15, 2016

Last Update Submit

June 22, 2019

Conditions

Spinal StenosisLumbosacral SpondylosisRadiculopathy

Outcome Measures

Primary Outcomes (5)

  • Change from baseline Visual Analogue Scale at 2, 6, 12 weeks

    2, 6, 12 weeks

  • Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks

    2, 6, 12 weeks

  • Change from baseline Standing tolerance test at 2, 6, 12 weeks

    2, 6, 12 weeks

  • Change from baseline Walking tolerance test at 2, 6, 12 weeks

    2, 6, 12 weeks

  • Change from baseline Patient satisfaction scale at 2, 6, 12 weeks

    2, 6, 12 weeks

Secondary Outcomes (1)

  • Complication of Caudal Epidural Steroid Injection

    2, 6, 12 weeks

Study Arms (2)

Group 1: 40 ml/min

ACTIVE COMPARATOR

Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 0.5 min

Drug: Triamcinolone Acetonide and normal saline solution

Group 2: 20 ml/min

EXPERIMENTAL

Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 1 min

Drug: Triamcinolone Acetonide and normal saline solution

Interventions

Triamcinolone Acetonide and normal saline solutionDRUG

80 mg/2 ml Triamcinolone Acetonide and 18 ml normal saline solution

Group 1: 40 ml/minGroup 2: 20 ml/min

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navamindradhiraj University

Dusit, Bangkok, 10300, Thailand

Location

Related Publications (3)

  • Watts RW, Silagy CA. A meta-analysis on the efficacy of epidural corticosteroids in the treatment of sciatica. Anaesth Intensive Care. 1995 Oct;23(5):564-9. doi: 10.1177/0310057X9502300506.

    PMID: 8787255RESULT

  • Botwin KP, Gruber RD, Bouchlas CG, Torres-Ramos FM, Sanelli JT, Freeman ED, Slaten WK, Rao S. Fluoroscopically guided lumbar transformational epidural steroid injections in degenerative lumbar stenosis: an outcome study. Am J Phys Med Rehabil. 2002 Dec;81(12):898-905. doi: 10.1097/00002060-200212000-00003.

    PMID: 12447088RESULT

  • Kraiwattanapong C, Wechmongkolgorn S, Chatriyanuyok B, Woratanarat P, Udomsubpayakul U, Chanplakorn P, Keorochana G, Wajanavisit W. Outcomes of fluoroscopically guided lumbar transforaminal epidural steroid injections in degenerative lumbar spondylolisthesis patients. Asian Spine J. 2014 Apr;8(2):119-28. doi: 10.4184/asj.2014.8.2.119. Epub 2014 Apr 8.

    PMID: 24761192RESULT

MeSH Terms

Conditions

Spinal StenosisRadiculopathy

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Satit Thiengwittayaporn, M.D.

    Navamindradhiraj University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 15, 2016

First Posted

October 20, 2016

Study Start

October 1, 2016

Primary Completion

August 2, 2018

Study Completion

January 30, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)