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Completed

NCT Number: NCT01407913

Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain

The study hypothesis is that caudal epidural steroid injections provides short term relief to patients with persistent low back pain and sciatica due degenerative disc disease or lumbar spinal stenosis. Patients will be evaluated wiht clinical examination and radiological examinations before injections. They will be followed up with questionnaires on pain and disability up to 6 months postinjection.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Ioannina

Ioannina, Greece

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • low back pain and sciatica due to lumbar disc herniation or lumbar spinals stenosis

Exclusion criteria

  • infection, cancer, allergy to steroids or anesthetic, non controlled diabetes or hypertension, clotting disorder

Treatment and study plan

caudal epidural steroid injection

Procedure

injecting steroids in the epidural space via caudal route

Primary outcomes

  1. change from preinjection of oswestry disability index at 15 days and at 3-6 months postinjection

    Time frame: pre injection to 3-6 months postinjection

  2. change from preinjection of Visual Analogue Scale at 15 days and at 3-6 months postinjection

    Time frame: preinjection to 3-6 months postinjection

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study title

Efficacy Study of Caudal Epidural Steroid Injections in Patients With Low Back Pain/Radiculopathy

Acronym: FIA1

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2011
Registry last updated
May 27, 2015

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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