PainPhase 4FIA1NCT01407913
Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain
A Phase 4 study testing caudal epidural steroid injection in people with Pain and Disability, run by University of Ioannina at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Disability
- What is being tested?
- caudal epidural steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2010to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- low back pain and sciatica due to lumbar disc herniation or lumbar spinals stenosis
Who cannot join
- infection, cancer, allergy to steroids or anesthetic, non controlled diabetes or hypertension, clotting disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Study of Caudal Epidural Steroid Injections in Patients With Low Back Pain/Radiculopathy
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.
- Conditions
- Pain, Disability
- Being tested
- caudal epidural steroid injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal epidural steroid injectionProcedure or surgery
injecting steroids in the epidural space via caudal route
What is being measured
The primary outcome is the main question the study is designed to answer.
change from preinjection of oswestry disability index at 15 days and at 3-6 months postinjection
Measured: pre injection to 3-6 months postinjection
change from preinjection of Visual Analogue Scale at 15 days and at 3-6 months postinjection
Measured: preinjection to 3-6 months postinjection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avraam Ploumis, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407913
- Sponsor's protocol ID
- 191/2010
- Acronym
- FIA1
- Status last verified
- May 2015
- First submitted
- 29 Jul 2011
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Caudal Epidural Steroid Injections in Patients With Low Back Pain/Radiculopathy
- ClinicalTrials.gov ID
- NCT01407913
- Acronym / sponsor ID
- FIA1 / 191/2010
- Conditions
- Pain, Disability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- low back pain and sciatica due to lumbar disc herniation or lumbar spinals stenosis
Key exclusion criteria (1 listed)
- infection, cancer, allergy to steroids or anesthetic, non controlled diabetes or hypertension, clotting disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caudal epidural steroid injectioninjecting steroids in the epidural space via caudal route | Procedure or surgery | – |
Primary outcome
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
change from preinjection of Visual Analogue Scale at 15 days and at 3-6 months postinjection
Time frame: preinjection to 3-6 months postinjection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing caudal epidural steroid injection in people with Pain and Disability, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.