Institutional Review Board, Hospital for Special Surgery
August 01, 2016
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Jennifer Solomon, MD
Richard Herzog, MD
Jonathan Kirschner, MD
Christopher Lutz, MD
This is a prospective, multicenter, study investigating the utility of intradiscal platelet rich plasma injections in patients with discogenic low back pain confirmed on discography. 10-12 study participants will be enrolled at Hospital for Special Surgery (70 total study participants at all sites) subsequently receive platelet rich plasma into the lumbar discs in which concordant pain is provoked via discography. The follow-up period (questionnaires on pain and function) will last for 1 year. Additionally, participants will undergo follow-up MRIs at 6 months after their injections.
A high index of suspicion for discogenic pain, i.e. painful degenerative discs with or without protrusions < 3mm
Age greater than 18 and less than 60 years
Maintained intervertebral disc heights of at least 50%
High intensity zone (HIZ) in annular fissure or adjacent to annular fissure detected on T2 or STIR MRI
Pain that is unresponsive to conservative treatment measures (oral medication, epidural steroid injections, physical therapy)
Pain persisting for an extended period of time (i.e., at least 3 months)
Pain relieved transiently with an epidural injection of anesthetic and steroid or documentation of a painful Grade 3 or 4 annular fissure on discography (Modified Dallas Discogram Classification)
No evidence of contraindications to undergo procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer
Spinal Deformity (Scoliosis >20 degrees, Spondylolysis, Spondylolisthesis)
Disc extrusions, sequestered fragments, severe thecal sac compression, or severe disc degeneration on MRI
No transient relief of pain after a diagnostic epidural injection and/or lack of concordant pain/annular disruption on discography
Presence of a Grade V annular fissure on discography
Multi-level disease (> 2 levels of involvement)
Prior lumbar surgery or intradiscal procedure (ie.IDET, Nucleoplasty)
Julian Harrison, BS