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Completed

NCT Number: NCT02939482

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

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.

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Key information

Conditions

Spinal Stenosis Bone Diseases Lumbosacral Spondylosis Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy Spinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Navamindradhiraj University

Dusit, Bangkok, 10300, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triamcinolone Acetonide and normal saline solution

Drug

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

Primary outcomes

  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 outcomes

  1. Complication of Caudal Epidural Steroid Injection

    Time frame: 2, 6, 12 weeks

Sponsors and collaborators

Lead sponsor

Navamindradhiraj University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 20, 2016
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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