Back PainNCT01089478
Cytology Study of Cells From Patients With Low Back Pain
An observational study of Back Pain, run by Texas Tech University Health Sciences Center.
Trial summary
The investigators are doing this study to learn more about the cause of back pain with or without pain shooting down one or both legs. The investigators specifically want to know if cells that move into injured areas of the body are present in a space in the spine (epidural space) of patients with back pain and with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- How many people
- 605 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Sep 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: consecutive patients receiving epidural neurolysis treatment for back pain
Who may be able to join
- Understand and voluntarily sign an informed consent form
- Age >18 years at the time of signing the informed consent form
- A diagnosis of low back pain with or without radiculopathy and scheduled for epiduroscopy assisted epidural neurolysis
Who cannot join
- Patients not scheduled for epiduroscopy assisted epidural neurolysis
- Are female who is pregnant
- Are a female of childbearing age and are not using an acceptable form of contraception
- Have a medical history or condition that would not make the patient a good candidate for epiduroscopy procedure
- Are unwilling or unable to provide written informed consent and/or to obey the study procedures
About this study
Official title: Cells in the Lumbar Epidural Space of Patients With Low Back Pain and/or Radiculopathy
The investigators are doing this study to learn more about the cause of back pain with or without pain shooting down one or both legs. The investigators specifically want to know if cells that move into injured areas of the body are present in a space in the spine (epidural space) of patients with back pain and with or without shooting pain. The investigators will collect cells when patients are being treated, then examine the cells using a microscope. The investigators also will shine different colors of light into the epidural space to see if there is a correlation between how different colors of light are reflected and the types of cells present.
Read the detailed description
The objective of this study is to examine the cell population in the epidural space of patients with low back pain +/- radiculopathy to determine if the cell population reveals pathological processes sustaining the pain. Cells will be collected for microscopic inspection and will be examined in situ during exposure to white and UV light. The overall goal is to advance our knowledge about the etiology of low back pain +/- radiculopathy to guide mechanistic based therapy.
The primary information sought is to determine if description of pathological processes based upon direct observation with percutaneously placed epiduroscopes can be confirmed by cytological analysis. the observations described include: 1) increased fibrosis from slight to complete replacement of other tissue, or obliteration of the epidural space; 2) alteration of color and/or appearance of epidural fat; 3) increased or decreased vascularity. The overall description range from acute inflammatory changes to advanced fibrosis (scarring).
Specimens for cytological analysis will be obtained from different sites in the epidural space by using commercially available cytology specimen collecting brushes and/or catheters. These are inserted through the working channel of an epiduroscope into the lumbar epidural space to aid treatment.
- Conditions
- Back Pain
- Keywords
- Back pain, Low back pain, Cytology, Epiduroscopy, Pain, Radiculopathy
- Medical subject headings
- Back Pain, Low Back Pain, Pain, Radiculopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of cell samples
The investigators expect that cell types identified will vary some from patient to patient depending in part upon how acute or chronic is the patient's disease and whether or not the patient has had prior surgery. The investigators expect the cells will indicate that a pathological process is present and will provide information about the characteristics of the process
Measured: 5 years
Secondary outcomes (1)
Reflect light
The investigators expect that different tissue types in the epidural space will reflect white light differently and that some cells involved in pathological processes will autofluoresce
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startApr 2005
- Primary completionSep 2019
- Study completionSep 2019
Why it stopped: Principal Investigator passed away.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James E Heavner, DVM, PhD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089478
- Sponsor's protocol ID
- L05-099
- Status last verified
- Jan 2020
- First submitted
- 17 Mar 2010
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cells in the Lumbar Epidural Space of Patients With Low Back Pain and/or Radiculopathy
- ClinicalTrials.gov ID
- NCT01089478
- Acronym / sponsor ID
- L05-099
- Conditions
- Back Pain
- Keywords
- Back pain, Low back pain, Cytology, Epiduroscopy, Pain, Radiculopathy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator passed away.
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Apr 2005 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 18 Mar 2010 (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 investigators are doing this study to learn more about the cause of back pain with or without pain shooting down one or both legs. The investigators specifically want to know if cells that move into injured areas of the body are present in a space in the spine (epidural space) of patients with back pain and with or without shooting pain. The investigators will collect cells when patients are being treated, then examine the cells using a microscope. The investigators also will shine different colors of light into the epidural space to see if there is a correlation between how different colors of light are reflected and the types of cells present.
Detailed description
The objective of this study is to examine the cell population in the epidural space of patients with low back pain +/- radiculopathy to determine if the cell population reveals pathological processes sustaining the pain. Cells will be collected for microscopic inspection and will be examined in situ during exposure to white and UV light. The overall goal is to advance our knowledge about the etiology of low back pain +/- radiculopathy to guide mechanistic based therapy.
The primary information sought is to determine if description of pathological processes based upon direct observation with percutaneously placed epiduroscopes can be confirmed by cytological analysis. the observations described include: 1) increased fibrosis from slight to complete replacement of other tissue, or obliteration of the epidural space; 2) alteration of color and/or appearance of epidural fat; 3) increased or decreased vascularity. The overall description range from acute inflammatory changes to advanced fibrosis (scarring).
Specimens for cytological analysis will be obtained from different sites in the epidural space by using commercially available cytology specimen collecting brushes and/or catheters. These are inserted through the working channel of an epiduroscope into the lumbar epidural space to aid treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients receiving epidural neurolysis treatment for back pain
Key inclusion criteria (3 listed)
- Understand and voluntarily sign an informed consent form
- Age >18 years at the time of signing the informed consent form
- A diagnosis of low back pain with or without radiculopathy and scheduled for epiduroscopy assisted epidural neurolysis
Key exclusion criteria (5 listed)
- Patients not scheduled for epiduroscopy assisted epidural neurolysis
- Are female who is pregnant
- Are a female of childbearing age and are not using an acceptable form of contraception
- Have a medical history or condition that would not make the patient a good candidate for epiduroscopy procedure
- Are unwilling or unable to provide written informed consent and/or to obey the study procedures
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
Characteristics of cell samples
Time frame: 5 years
The investigators expect that cell types identified will vary some from patient to patient depending in part upon how acute or chronic is the patient's disease and whether or not the patient has had prior surgery. The investigators expect the cells will indicate that a pathological process is present and will provide information about the characteristics of the process
1 secondary outcome
Reflect light
Time frame: 10 years
Results and safety
The study was stopped early (reason given: Principal Investigator passed away.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
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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.
James E Heavner, DVM, PhD principal investigator
Texas Tech University Health Sciences Center
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain, run by Texas Tech University Health Sciences Center.
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 5 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 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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: Principal Investigator passed away.). 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?
Characteristics of cell samples (time frame: 5 years). 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 6 Jan 2020.