NCT01407913

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_4 pain

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, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

3.7 years

First QC Date

July 29, 2011

Last Update Submit

May 26, 2015

Conditions

PainDisability

Outcome Measures

Primary Outcomes (2)

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

    pre injection to 3-6 months postinjection

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

    preinjection to 3-6 months postinjection

Interventions

caudal epidural steroid injectionPROCEDURE

injecting steroids in the epidural space via caudal route

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Ioannina

Ioannina, Greece

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of PMR, Orthopaedic Spine Surgeon

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 2, 2011

Study Start

October 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

GR(1)