Lumbosacral RadiculopathyNCT01836770
Epidural Contrast Flow Patterns of TESI Using the Inferior-Anterior Position as the Final Needle Tip Position.
An observational study of Lumbosacral Radiculopathy and Lumbar Herniated Nucleus Pulposus, run by George Washington University at 1 site in United States.
Trial summary
The purpose of this study is to describe the contrast flow patterns in the epidural space using the inferior-anterior approach with continuous fluoroscopic guidance, and determine how well this approach correlates with appropriate contrast flow patterns and with analgesia at follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbosacral Radiculopathy, Lumbar Herniated Nucleus Pulposus
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to 20 Jun 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: George Washington Spine and Pain Center patients.
Who may be able to join
- 18 years of age or older
- History of lumbosacral radiculopathy or lumbar herniated nucleus pulposus
- Scheduled for TFESI at GW Spine and Pain Center
Who cannot join
- Pregnant or plan on becoming pregnant
- Have undergone TFESI in the past year
- Opioid habituation
- Lumbo-sacral stenosis
- Lumbar surgery
- Lumbar spondylolisthesis
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington Spine and Pain Center
Washington D.C., District of Columbia, 20037
About this study
Official title: Epidural Contrast Flow Patterns of Transforaminal Epidural Steroid Injections Using the Inferior-Anterior Position as the Final Needle Tip Position.
The purpose of this study is to describe the contrast flow patterns in the epidural space using the inferior-anterior approach with continuous fluoroscopic guidance, and determine how well this approach correlates with appropriate contrast flow patterns and with analgesia at follow up. This knowledge may prove useful in guiding physician practice patterns in the non-surgical management of low back pain.
Hypothesis: The investigators hypothesize that there will be suitable (ventral/anterior) epidural contrast spread based on inferior-anterior needle-tip position, particularly with appropriate needle tip position.
- Keywords
- Transforaminal Epidural Steroid Injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transforaminal Epidural Steroid Injection | Patients with a history of lumbosacral radiculopathy or lumbar herniated nucleus pulposus, scheduled for Transforaminal Epidural Steroid Injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast flow patterns
Contrast flow patterns will be used as the primary outcome measure. The statistical test to be employed is to compare the proportions of patients in the study who experienced posterior flow, anterior flow and if that anterior flow had spread to more than 1 vertebral level in either direction, what that direction was, and the presence or absence of vascular flow.
Measured: 3 Months
Secondary outcomes (1)
VAS pain score
VAS Pain Score - The statistical test to be employed is Wilcoxon Signed Rank Test to compare if there is a difference in pain score at appointments 1 months and 3 months post-injection relative to pre-injection.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startAug 2010
- Primary completion20 Jun 2013
- Study completion20 Jun 2013
Why it stopped: lack of enrollment; terminated by the Principal Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehul J Desai, MD MPH, Principal investigator, George Washington Spine and Pain Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836770
- Sponsor's protocol ID
- Kambin
- Status last verified
- Mar 2018
- First submitted
- 7 Jan 2013
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Contrast Flow Patterns of Transforaminal Epidural Steroid Injections Using the Inferior-Anterior Position as the Final Needle Tip Position.
- ClinicalTrials.gov ID
- NCT01836770
- Acronym / sponsor ID
- Kambin
- Keywords
- Transforaminal Epidural Steroid Injections
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of enrollment; terminated by the Principal Investigator
- Enrolment
- 5 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Aug 2010 (actual)
- Primary completion
- 20 Jun 2013 (actual)
- Study completion
- 20 Jun 2013 (actual)
- First posted
- 22 Apr 2013 (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 purpose of this study is to describe the contrast flow patterns in the epidural space using the inferior-anterior approach with continuous fluoroscopic guidance, and determine how well this approach correlates with appropriate contrast flow patterns and with analgesia at follow up. This knowledge may prove useful in guiding physician practice patterns in the non-surgical management of low back pain.
Hypothesis: The investigators hypothesize that there will be suitable (ventral/anterior) epidural contrast spread based on inferior-anterior needle-tip position, particularly with appropriate needle tip position.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transforaminal Epidural Steroid Injection | – | –Patients with a history of lumbosacral radiculopathy or lumbar herniated nucleus pulposus, scheduled for Transforaminal Epidural Steroid Injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- George Washington Spine and Pain Center patients.
Key inclusion criteria (3 listed)
- 18 years of age or older
- History of lumbosacral radiculopathy or lumbar herniated nucleus pulposus
- Scheduled for TFESI at GW Spine and Pain Center
Key exclusion criteria (6 listed)
- Pregnant or plan on becoming pregnant
- Have undergone TFESI in the past year
- Opioid habituation
- Lumbo-sacral stenosis
- Lumbar surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Contrast flow patterns
Time frame: 3 Months
Contrast flow patterns will be used as the primary outcome measure. The statistical test to be employed is to compare the proportions of patients in the study who experienced posterior flow, anterior flow and if that anterior flow had spread to more than 1 vertebral level in either direction, what that direction was, and the presence or absence of vascular flow.
1 secondary outcome
VAS pain score
Time frame: 3 months
Results and safety
The study was stopped early (reason given: lack of enrollment; terminated by the Principal Investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
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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.
Mehul J Desai, MD MPH principal investigator
George Washington Spine and Pain Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbosacral Radiculopathy and Lumbar Herniated Nucleus Pulposus, run by George Washington University at 1 site in United States.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Mar 2018. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: lack of enrollment; terminated by the Principal Investigator). Results are not available in the source record.
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?
Contrast flow patterns (time frame: 3 Months). 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 5 Mar 2018.