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Lumbar Intradiscal Platelet-Rich Plasma Injections: A Prospective, Double-blinded, Randomized Controlled Study

IRB Number: 29025

September 16, 2009

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

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Principal Investigator

Gregory E. Lutz, MD


Christopher Lutz, MD
Jennifer L. Solomon, MD
Alon Terry, MD
Elizabeth LaSalle


This is a prospective, randomized controlled study investigating the utility of intradiscal platelet-rich plasma injections in patients with discogenic mediated low back pain as determined by discography. A total number of 72 pateints will be enrolled and subsequently randomized in a 2:1 ratio to receive either platelet-rich plasma or additional contrast agent, respectively, into the lumbar intradiscal level that causes concordant pain at the time of a discogram procedure.  Enrollment will begin at the time of full IRB approval.  The follow-up period will last for 6 months.

Inclusion/Exclusion Criteria

Inclusion Criteria: 
• Surgical management is a viable option
• A high index of suspicion for discogenic pain, ie. painful degenerative discs
• Maintained intervertebral disc heights of at least 50%
• Pain is not responsive to conservative treatment measures
• Failed back surgery
• Pain persists for an extended period of time (i.e., at least 3 months)
• No evidence of contraindications, such as spinal stenosis

Exclusion Criteria
• Patients with a known bleeding disorder and those on anticoagulation therapy
• Pregnancy
• Systemic infection or skin infection over the puncture site
• Allergy to contrast
• Psychiatric conditions such as PTSD or schizophrenia
• Solid bone fusion that does not allow access to the disc
• Severe spinal canal compromise at the disc levels to be investigated
• Severe intervertebral disc protrusions greater than 5mm, extrusions, or sequestered fragments
• Spondylolisthesis greater than grade I and/or evidence of instability on flexion and extension radiographs of the lumbar spine

Contact Information

Elizabeth LaSalle