Institutional Review Board, Hospital for Special Surgery
September 16, 2009
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an 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.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
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.
• 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
• Patients with a known bleeding disorder and those on anticoagulation therapy
• 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