Low Back PainNCT00371618
IPM Procedures With or Without Fluoroscopy: Outcome Comparison
An observational study of Low Back Pain and Neck Pain, run by Pain Management Center of Paducah at 1 site in United States.
Trial summary
To determine clinically significant improvement in the patients undergoing procedures under fluoroscopy. To evaluate and compare the adverse event profile in both groups Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Neck Pain
- What is being tested?
- Fluoroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to May 2004
- 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: currently enrolled patients
Who may be able to join
- Patients who have undergone the following procedures:
- Cervical facet joint nerve blocks, thoracic facet joint nerve blocks, lumbar facet joint nerve blocks, lumbar interlaminar epidural steroid injections, cervical Interlaminar epidural steroid injections
- During 1998 to 2001 and 2004 to 2005
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Outcomes of Interventional Pain Management Procedures Performed With or Without Fluoroscopy: A Retrospective Analysis
To determine clinically significant improvement in the patients undergoing procedures under fluoroscopy.
To evaluate and compare the adverse event profile in both groups
Read the detailed description
For the target delivery of injectate, it is believed that fluoroscopy is mandatory. However, there is a view among some professionals that a procedure may be performed without fluoroscopy as effectively as under fluoroscopy. The outcomes among the two groups of patients have not been studied
- Conditions
- Low Back Pain, Neck Pain
- Being tested
- Fluoroscopy
- Keywords
- Fluoroscopy, Interventional Pain Management Procedures
- Medical subject headings
- Low Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoroscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate clinically significant improvement in the patients undergoing procedures under fluoroscopy.
To evaluate and compare the adverse event profile in both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startJan 1998
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Management Center of Paducah
- Sponsor type
- University, hospital or other
- Investigators
- Laxmaiah Manchikanti, MD, Principal investigator, Ambulatory Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371618
- Sponsor's protocol ID
- protocol 13
- Status last verified
- Oct 2015
- First submitted
- 1 Sep 2006
- Last updated
- 21 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Interventional Pain Management Procedures Performed With or Without Fluoroscopy: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT00371618
- Acronym / sponsor ID
- protocol 13
- Conditions
- Low Back Pain, Neck Pain
- Keywords
- Fluoroscopy, Interventional Pain Management Procedures
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pain Management Center of PaducahUniversity, hospital or other
- Study start
- Jan 1998
- Study completion
- May 2004
- First posted
- 4 Sep 2006 (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.
To determine clinically significant improvement in the patients undergoing procedures under fluoroscopy.
To evaluate and compare the adverse event profile in both groups
Detailed description
For the target delivery of injectate, it is believed that fluoroscopy is mandatory. However, there is a view among some professionals that a procedure may be performed without fluoroscopy as effectively as under fluoroscopy. The outcomes among the two groups of patients have not been studied
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- currently enrolled patients
Key inclusion criteria (4 listed)
- Cervical facet joint nerve blocks, thoracic facet joint nerve blocks, lumbar facet joint nerve blocks, lumbar interlaminar epidural steroid injections, cervical Interlaminar epidural steroid injections
- During 1998 to 2001 and 2004 to 2005
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Fluoroscopy | Procedure or surgery | – |
Primary outcome
To demonstrate clinically significant improvement in the patients undergoing procedures under fluoroscopy.
To evaluate and compare the adverse event profile in both groups
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 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.
Laxmaiah Manchikanti, MD principal investigator
Ambulatory Surgery 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 Low Back Pain and Neck Pain, run by Pain Management Center of Paducah 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 4 inclusion and 0 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: withdrawn, as of the sponsor's last update on 21 Oct 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 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 withdrawn before enrolling participants, so there are no results.
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?
To demonstrate clinically significant improvement in the patients undergoing procedures under fluoroscopy.. 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 21 Oct 2015.