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Discogenic Low Back Pain Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04652687
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : January 25, 2023
Sponsor:
Collaborator:
Talosix
Information provided by (Responsible Party):
VIVEX Biologics, Inc.

Brief Summary:
Registry is to observe and trend patterns of care and outcomes for the standard of care treatments of discogenic chronic LBP.

Condition or disease Intervention/treatment
Discogenic Pain Low Back Pain Biological: VIA Disc NP Drug: Transforaminal Epidural steroid injection Behavioral: Lifestyle modification Other: Physical therapy

Detailed Description:
The Discogenic Low Back Pain (LBP) Registry is intended to complement and integrate data collected in ongoing randomized-controlled clinical studies to aid in establishing payor coverage in the United States (US) for VIA Disc NP with real-world data. This registry will, in turn, further assist in establishing a health economics argument for use of VIA Disc NP in medical facilities for US payors and provide real-world data to support ongoing quality for care initiatives.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Discogenic Low Back Pain Registry
Actual Study Start Date : May 3, 2020
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort Intervention/treatment
VIA Disc NP
Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment for discogenic low back pain.
Biological: VIA Disc NP
VIA Disc NP - Allograft tissue injection

Non Surgical Management
Patients receiving non surgical management (i.e., physical therapy, transforaminal epidural steroid injection, lifestyle modification, or surgical intervention)
Drug: Transforaminal Epidural steroid injection
epidural injection of steroid into the affected area of low back pain

Behavioral: Lifestyle modification
physician instructed changes to patient's daily activities to alleviate low back pain

Other: Physical therapy
Physician ordered physical therapy and exercises to alleviate low back pain




Primary Outcome Measures :
  1. Patient self-reporting of overall health [ Time Frame: 1, 3, 6, 12, 24, & 36 months ]
    Change in scores from Patient Reported Outcomes Measurement Information System (PROMIS-10). 10-item questionnaire used to assess general domains of health and function, including overall physical health, mental health, social health, pain, fatigue and overall perceived quality of life.

  2. Patient self-reporting of daily function [ Time Frame: 1, 3, 6, 12, 24, & 36 months ]
    Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to low back pain.

  3. Patient self-reported back pain [ Time Frame: 1, 3, 6, 12, 24, & 36 months ]
    Change in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).


Secondary Outcome Measures :
  1. Employment Status [ Time Frame: 1, 3, 6, 12, 24, & 36 months ]
    Patient reported return to work - same or different capacity answers to employment questions will be assessed across time points and compared.

  2. Resource Utilization [ Time Frame: 1, 3, 6, 12, 24, & 36 months ]
    Patient reported assessment of healthcare and resources utilized questions to treat ongoing discogenic low back pain post treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Registry will include at least 1,000 patients diagnosed with and treated for discogenic low back pain across approximately 40 selected sites.
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Understand and sign the informed consent form (as applicable)
  • Discogenic Low Back pain diagnosis made and/or confirmed at participating site based on:
  • Axial low back pain and discomfort
  • Sitting intolerance
  • Increased pain with bending forward, sustained hip flexion and compression
  • Pain is less with lying down or hip extension
  • Evidence of degenerated lumbar disc on MRI
  • Minimum of six (6) months prior non-surgical management

Exclusion Criteria:

  • Disc extrusions or sequestration
  • Symptomatic spinal stenosis
  • Spondylolsthesis of grade 2 or higher
  • Lumbar spondylitis
  • Vertebral compression fracture at any level
  • Any medical condition that impairs follow-up (i.e., fibromyalgia, rheumatoid arthritis, chronic regional pain syndrome, reflex sympathetic dystrophy) Evidence of substance abuse or patients using prescribed extended-release narcotics (e.g., fentanyl patch, MS Contin, oxycontin) within 3 months prior to screening
  • Evidence of mental instability (bipolar disorders, post-traumatic stress disorder (PTSD) or uncontrolled anxiety/depression); requiring new or any change in anti-depressants or anti-psychotic medications; or in opinion of the investigator is not a reliable candidate
  • Discogenic Low Back Pain is due to worker's compensation and/or a personal injury case. Litigation is occurring or expected during study participation.
  • Altered mental status or any language barriers that would prevent completion of the patient reported outcome surveys after the procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652687


Contacts
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Contact: Alex McClellan, BS 888-684-7783 amcclellan@vivex.com
Contact: Hunter Hall hhall@vivex.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
VIVEX Biologics, Inc.
Talosix
Investigators
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Study Director: Lisa Finstein, MHA Vivex Biologics
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Responsible Party: VIVEX Biologics, Inc.
ClinicalTrials.gov Identifier: NCT04652687    
Other Study ID Numbers: VIV-001-020
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VIVEX Biologics, Inc.:
low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations