Low Back PainPhase 2/3NCT04621799
Fibrin for Chronic Multi-level Discogenic Low Back Pain
A Phase 2/3 study testing Fibrin sealant in people with Low Back Pain and Disc Disease, run by Pauza, Kevin, MD at 1 site in United States.
Trial summary
Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Disc Disease, Disc Degeneration
- What is being tested?
- Fibrin sealant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 30 Jun 2021
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recipient of Intra-annular fibrin injection for annular defects identified radographically and by annulogram
Who cannot join
- Scoliosis greater than 20 degrees
- Spondylolysis
- Spondylolisthesis greater than Grade 1
- Disc extrusion
- Disc herniations or bulges > 4mm causing severe stenosis
- Prior lumbar surgery or intradiscal procedure (i.e. intradiscal electrothermal therapy, nucleoplasty)
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- Cauda equina syndrome
- Active malignancy or tumor as source of symptoms
- Evidence of prior lumbar vertebral body fracture or trauma
- Foraminal stenosis at the affected levels resulting in severe thecal sac compression
- Dynamic instability on lumbar flexion/extension radiographs
- Positive response to diagnostic medial branch block or facet joint injection or sacroiliac joint injection
- Known bleeding disorder
- Known or suspected hypersensitivity or allergy to drugs or components of the fibrin sealant, including aprotinin, used in the procedure
- Presence of ferromagnetic implants that would interfere with MRI evaluations
- Active or pending workers' compensation claims or other litigation related to the condition.
- Pregnant or plans to become pregnant over the course of study participation (2 years)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Interventional Spine Specialist
Tyler, Texas, 75701
Carrie Wright, 903-941-9357, carrie@drkevinpauza.com
About this study
Official title: A Prospective Registry Study Evaluating the Safety and Efficacy of Fibrin for Chronic Multi-level Discogenic Low Back Pain
Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).
Read the detailed description
The purpose of this study is to analyze data available in the PIs Regenerative Orthobiologics Registry (ROR) and corresponding patient charts that will either support or refute the efficacy of Intra-annular fibrin as treatment for moderate to severe low back pain. Additionally, we seek to retrospectively identify possible predisposing factors that are correlated with positive outcomes with respect to patient-reported pain and function.
- Conditions
- Low Back Pain, Disc Disease, Disc Degeneration, Radiculopathy, Annular Disc Tear
- Being tested
- Fibrin sealant
- Keywords
- Non-autologous fibrin, Minimally Invasive, Injections, Intervertebral disc, Annulus Fibrosus, Sciatica
- Medical subject headings
- Low Back Pain, Intervertebral Disc Degeneration, Radiculopathy, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin sealantDrug
Also called Baxter Tisseel
The intra-annular delivery of non-autologous fibrin into the annulus
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Group | Experimental | Experimental: Non-Autologuos Fibrin (NAF) Subjects in the NAF arm received an injection of non-autologous fibrin Receives: Drug: Fibrin sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).
Measured: Two Years
Secondary outcomes (7)
Numeric Rating Scale (NRS)
The NRS consists of a numeric version of the visual analog scale. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. Scale for NRS is from 0 (best) - 10 (worst).
Measured: Two Years
Visual Analog Scale (VAS) for back pain
When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for back pain is from 0 (best) - 10 (worst).
Measured: Two Years
Visual Analog Scale (VAS) for leg pain
When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for leg pain is from 0 (best) - 10 (wors
Measured: Two Years
PROMIS Physical Health
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Physical Health is from 16.2 (worst) - 67.7 (best)
Measured: Two Years
PROMIS Mental Health
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Mental Health is from 21.2 (worst) - 67.6 (best).
Measured: Two Years
North American Spine Society (NASS) for patient satisfaction
The North American Spine Society (NASS) developed an outcome assessment instrument to measure diverse dimensions of the impact of lumbar spine problems. Scale range is from 1 to 4 (best to worst).
Measured: Two Years
EURO Quality of Life (EuroQol)
EuroQol is an instrument which evaluates the generic quality of life developed in Europe and widely used. Scale is from 0.33 (worst - 0.88 (best).
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start11 Jun 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective evaluation of a cohort of patients with a specific characteristic over time to see if they develop a particular endpoint or outcome based on a stated hypothesis
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pauza, Kevin, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Pauza, MD, Principal investigator, INTERVENTIONAL SPINE SPECIALIST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621799
- Sponsor's protocol ID
- Regen_006-0120
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry Study Evaluating the Safety and Efficacy of Fibrin for Chronic Multi-level Discogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT04621799
- Acronym / sponsor ID
- Regen_006-0120
- Conditions
- Low Back Pain, Disc Disease, Disc Degeneration, Radiculopathy, Annular Disc Tear
- Keywords
- Non-autologous fibrin, Minimally Invasive, Injections, Intervertebral disc, Annulus Fibrosus, Sciatica
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Pauza, Kevin, MDUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 9 Nov 2020 (actual)
- 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.
Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).
Detailed description
The purpose of this study is to analyze data available in the PIs Regenerative Orthobiologics Registry (ROR) and corresponding patient charts that will either support or refute the efficacy of Intra-annular fibrin as treatment for moderate to severe low back pain. Additionally, we seek to retrospectively identify possible predisposing factors that are correlated with positive outcomes with respect to patient-reported pain and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective evaluation of a cohort of patients with a specific characteristic over time to see if they develop a particular endpoint or outcome based on a stated hypothesis
| Arm | Type | Receives |
|---|---|---|
| Fibrin Group | Experimental | Drug: Fibrin sealantExperimental: Non-Autologuos Fibrin (NAF) Subjects in the NAF arm received an injection of non-autologous fibrin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recipient of Intra-annular fibrin injection for annular defects identified radographically and by annulogram
Key exclusion criteria (17 listed)
- Scoliosis greater than 20 degrees
- Spondylolysis
- Spondylolisthesis greater than Grade 1
- Disc extrusion
- Disc herniations or bulges > 4mm causing severe stenosis
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 |
|---|---|---|
| Fibrin sealantAlso: Baxter TisseelThe intra-annular delivery of non-autologous fibrin into the annulus | Drug | Fibrin Group |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: Two Years
The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).
7 secondary outcomes
Numeric Rating Scale (NRS)
Time frame: Two Years
Visual Analog Scale (VAS) for back pain
Time frame: Two Years
Visual Analog Scale (VAS) for leg pain
Time frame: Two Years
PROMIS Physical Health
Time frame: Two Years
PROMIS Mental Health
Time frame: Two Years
North American Spine Society (NASS) for patient satisfaction
Time frame: Two Years
EURO Quality of Life (EuroQol)
Time frame: Two Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Kevin Pauza, MD principal investigator
INTERVENTIONAL SPINE SPECIALIST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fibrin sealant in people with Low Back Pain and Disc Disease, run by Pauza, Kevin, MD 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 1 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 9 Nov 2020. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin Pauza, MD (239-317-3108, kevinpauza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: Two 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 9 Nov 2020.