IRB Number: 11107
Institutional Review Board, Hospital for Special Surgery
July 11, 2011
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.
Peter J. Moley, MD
Christopher Lutz, MD
Paul M. Cooke, MD
Alexander C. Simotas, MD
Joseph H. Feinberg, MD
Stephen Massimi, MD
Elizabeth LaSalle, BA
A total of 60 patients will participate in this study, the overall participation period will be 1 year. Participation will involve a total of 1-2 study visits as well as 5 follow-up questionnaires after the procedure. The first visit will involve a cyst rupture procedure and will last about 45 minutes to 1 hour, including recovery time. The paper/online questionnaires, thereafter, are expected to take about 15 minutes to complete.
Patient inclusion criteria includes:
• The diagnosis of a symptomatic low back pain with lower extremity radiculopathy.
• MRI findings demonstrate the presence of a zygapophyseal joint synovial cyst at the corresponding level and side of symptoms.
• Failure of NSAIDs and PT, or if pain limits progress in PT
• Moderate to Severe Pain
Patient exclusion criteria includes
• Calcification of their synovial cyst seen on imaging.
• History of previous zygapophyseal joint cyst aspiration procedure.
• Low back pain that is multifactorial and with clinical symptoms associated with other underlying lumbar pathology such as disc herniation, scoliosis, or vertebral fracture.
• Prior spinal surgery at same level or prior fusion at any lumbar level.
• Severe stenosis (may have mild stenosis with no nerve root impingement)
• Contraindication to injections (infection, uncontrolled diabetes)
Elizabeth LaSalle, BALaSalleE@hss.edu