Low Back PainNCT01089491
Study of Cells From Spinal Cavity of Patients With Low Back Pain
An observational study of Low Back Pain, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
The purpose of this study to determine if cells collected give us information about what is causing a patient pain can be detected and connected with epiduroscopy images (pictures taken with a small fiber optic scope). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2010
- 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 outpatient lysis of adhesions treatment at University Medical Center in Lubbock TX.
Who may be able to join
- Understand and voluntarily sign the informed consent and HIPAA forms
- Age >18 years at the time of signing the informed consent
- Scheduled for epiduroscopy assisted epidural neurolysis
- A diagnosis of low back pain with or without radiculopathy
Who cannot join
- Not scheduled for epiduroscopy assisted epidural neurolysis
- In the opinion of the investigator, the patient's overall condition is not suitable for inclusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: Localization and Characterization of Cells in the Lumbar Epidural Cavity of Patients With Low Back Pain With or Without Radiculopathy
The purpose of this study to determine if cells collected give us information about what is causing a patient pain can be detected and connected with epiduroscopy images (pictures taken with a small fiber optic scope). We want to determine if abnormal areas are the source of that pain by using a catheter to provide a brief, low intensity electrical stimulation. We also want to determine if there are cells in the epidural cavity (area surrounding the spinal cord) of patients who have low back pain with or without pain shooting down one or both legs that provide information about what is causing the pain.
Read the detailed description
The pain group at TTUSOM has pioneered a treatment for low back pain with or without radiculopathy called epidural neurolysis (or other names, e.g.: lysis of epidural adhesions, the Racz procedure). This technique is now used worldwide. The treatment is based on substantial evidence that pathological processes within the epidural space innate and sustain pain. The goal of epidural neurolysis is to deposit therapeutic agents directly into the area of pathology (i.e., targeted drug delivery). The procedure involves documentation via epidurograms that radio opaque material injected into the epidural space prior to treatment does not enter the suspected area of pathology. This area is determined by signs and symptoms revealed by the patient history and physical examination.
After a filling defect that corresponds to the suspected area of pathology is documented by epidurography, a specially designed catheter is directed into the defect. Mechanical forces applied by the catheter and hydraulic forces applied by injection of isotonic saline through the catheter as well as injection of hyaluronidase, are used to enter and remove barriers to targeted delivery of drug. Next drugs, usually corticosteroid, local anesthetic and hypertonic saline, are injected to treat what is presumed to be inflammation and edema.
More recently, epiduroscopy has been introduced as an aid to epidural neurolysis. Epiduroscopy allows visual inspection of epidural tissue. Epiduroscopy is performed by inserting a flexible endoscope through the sacral hiatus. Using epiduroscopy, we and others have observed change in the epidural space that we believe are related to the etiology of the pain. We see changes consistent with various stages of inflammation either acute or chronic. We see increases in vascularity, displacement of fat by fibrous tissue as well as changes in the texture and color of peridural fat.
We have developed a method for retrieving cells from suspected areas of pathology and of culturing the cells via the working channel of the epiduroscope using a cytology brush. The collected cells are characterized to establish a diagnosis and to aid treatment.
To confirm areas which appear to be abnormal when viewed via epiduroscopy are involved in the painful condition for which the patient is seeking treatment, we test the area with hydrostatic pressure (saline injection) or by touching with the epiduroscope tip (mechanical stimulation). These stimuli do not normally elicit pain. However, when the stimulus does elicit pain in the region of the painful region of the patient's body, the abnormal appearing tissue in the epidural space is considered to be involved in painful process affecting the patient. This is similar to "pain mapping" done by others when electrical stimulation is used to search for the area of pathology. Adapting this approach, applying electrical stimulation via a stimulating probe (FDA approved) inserted through the working channel of the epiduroscope will allow more precise localization of pathological tissue than does the methods we currently use.
We will collect cells during epiduroscopy and characterize them in vitro. A new dimension of this project is to deliver electrical stimulation to more accurately locate the source of pain from where cells should be sampled.
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Epiduroscopy, Cytology, Electrical stimulation
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of cell types
We 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. We expect the cells will indicate that a pathological process is present and will provide information about the characteristics of the process.
Measured: 6 months
Secondary outcomes (1)
Electrical stimulation to locate pain
We expect that electrical stimulation will improve the precision with which abnormal, painful structures are localized and thereby improve collection of cells directly involved in the patient's pain.
Measured: 6 months to 1 year
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 startMar 2010
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: PI chose not to conduct the study; no data collected.
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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Investigators
- James E Heavner, DVM, PhD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089491
- Sponsor's protocol ID
- L10-081
- Status last verified
- May 2015
- First submitted
- 17 Mar 2010
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localization and Characterization of Cells in the Lumbar Epidural Cavity of Patients With Low Back Pain With or Without Radiculopathy
- ClinicalTrials.gov ID
- NCT01089491
- Acronym / sponsor ID
- L10-081
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Epiduroscopy, Cytology, Electrical stimulation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI chose not to conduct the study; no data collected.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (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 purpose of this study to determine if cells collected give us information about what is causing a patient pain can be detected and connected with epiduroscopy images (pictures taken with a small fiber optic scope). We want to determine if abnormal areas are the source of that pain by using a catheter to provide a brief, low intensity electrical stimulation. We also want to determine if there are cells in the epidural cavity (area surrounding the spinal cord) of patients who have low back pain with or without pain shooting down one or both legs that provide information about what is causing the pain.
Detailed description
The pain group at TTUSOM has pioneered a treatment for low back pain with or without radiculopathy called epidural neurolysis (or other names, e.g.: lysis of epidural adhesions, the Racz procedure). This technique is now used worldwide. The treatment is based on substantial evidence that pathological processes within the epidural space innate and sustain pain. The goal of epidural neurolysis is to deposit therapeutic agents directly into the area of pathology (i.e., targeted drug delivery). The procedure involves documentation via epidurograms that radio opaque material injected into the epidural space prior to treatment does not enter the suspected area of pathology. This area is determined by signs and symptoms revealed by the patient history and physical examination.
After a filling defect that corresponds to the suspected area of pathology is documented by epidurography, a specially designed catheter is directed into the defect. Mechanical forces applied by the catheter and hydraulic forces applied by injection of isotonic saline through the catheter as well as injection of hyaluronidase, are used to enter and remove barriers to targeted delivery of drug. Next drugs, usually corticosteroid, local anesthetic and hypertonic saline, are injected to treat what is presumed to be inflammation and edema.
More recently, epiduroscopy has been introduced as an aid to epidural neurolysis. Epiduroscopy allows visual inspection of epidural tissue. Epiduroscopy is performed by inserting a flexible endoscope through the sacral hiatus. Using epiduroscopy, we and others have observed change in the epidural space that we believe are related to the etiology of the pain. We see changes consistent with various stages of inflammation either acute or chronic. We see increases in vascularity, displacement of fat by fibrous tissue as well as changes in the texture and color of peridural fat.
We have developed a method for retrieving cells from suspected areas of pathology and of culturing the cells via the working channel of the epiduroscope using a cytology brush. The collected cells are characterized to establish a diagnosis and to aid treatment.
To confirm areas which appear to be abnormal when viewed via epiduroscopy are involved in the painful condition for which the patient is seeking treatment, we test the area with hydrostatic pressure (saline injection) or by touching with the epiduroscope tip (mechanical stimulation). These stimuli do not normally elicit pain. However, when the stimulus does elicit pain in the region of the painful region of the patient's body, the abnormal appearing tissue in the epidural space is considered to be involved in painful process affecting the patient. This is similar to "pain mapping" done by others when electrical stimulation is used to search for the area of pathology. Adapting this approach, applying electrical stimulation via a stimulating probe (FDA approved) inserted through the working channel of the epiduroscope will allow more precise localization of pathological tissue than does the methods we currently use.
We will collect cells during epiduroscopy and characterize them in vitro. A new dimension of this project is to deliver electrical stimulation to more accurately locate the source of pain from where cells should be sampled.
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 outpatient lysis of adhesions treatment at University Medical Center in Lubbock TX.
Key inclusion criteria (4 listed)
- Understand and voluntarily sign the informed consent and HIPAA forms
- Age >18 years at the time of signing the informed consent
- Scheduled for epiduroscopy assisted epidural neurolysis
- A diagnosis of low back pain with or without radiculopathy
Key exclusion criteria (2 listed)
- Not scheduled for epiduroscopy assisted epidural neurolysis
- In the opinion of the investigator, the patient's overall condition is not suitable for inclusion
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 types
Time frame: 6 months
We 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. We expect the cells will indicate that a pathological process is present and will provide information about the characteristics of the process.
1 secondary outcome
Electrical stimulation to locate pain
Time frame: 6 months to 1 year
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 12 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.
James E Heavner, DVM, PhD principal investigator
Texas Tech University Health Sciences 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, run by Texas Tech University Health Sciences Center 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 2 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 12 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 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?
Characteristics of cell types (time frame: 6 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 12 May 2015.