September 16, 2009
Institutional Review Board, Hospital for Special Surgery
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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 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
Elizabeth LaSalle
LaSalleE@hss.edu
212.774.7386