Discogenic Low Back Pain Registry

  • STATUS
    Recruiting
  • End date
    Jul 8, 2025
  • participants needed
    1000
  • sponsor
    Vivex Biomedical, Inc.
Updated on 8 September 2021
back pain
low back pain

Summary

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

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.

Details
Condition Low Back Pain, Back Pain, Chronic Back Pain, Discogenic Pain, Lower Back Pain, lumbago
Treatment Physical therapy, Lifestyle modification, Transforaminal epidural steroid injection, VIA Disc, VIA Disc NP
Clinical Study IdentifierNCT04652687
SponsorVivex Biomedical, Inc.
Last Modified on8 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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