The Ainsworth Institute of Pain Management has been selected for a new FDA Clinical Trial for low back coming from degenerative disc disease. This study will evaluate an experimental medication called “SB-01” for the treatment of low back pain caused by a degenerative disc (aka discogenic pain) in the lumbar spine. We are one of several sites throughout the country participating in this truly unique study!
Degenerative disc disease (DDD) is a general term used to describe when the discs in your spine lose water, as well as height, and become black on an MRI. For many, this condition is extremely painful and can severely limit activity. Unfortunately, there is no way to “fix” a degenerative disc – once the water leaves a disc, it is gone forever and the pain becomes a permanent condition. In the last decade, there have been a number of clinical trials aimed at injected stem cells into degenerative discs to grow new tissue from the inside to repair it. While potentially effective, stem cells do not address whatever the underlying issue is that caused that disc to degenerative in the first place…that is where Spine Biopharma and SB-01 come in.
DRG Stimulation (SCS)
DRG stimulation is one of THE most impressive advancements ever seen in the field of pain management. According to the United States FDA clinical trial, patients with CRPS who were treated with the DRG stimulator reported, on average, 81.4% to 86% reduction in pain. In addition, sensitivity, swelling and skin color – all have been have been shown to improve with this amazing therapy
Spinal Cord Stimulation
SCS is an innovative procedure that has yielded results for patients with pain in their back or limbs who have not found relief from any other treatments. In SCS, an electrical pulse is delivered directly to the spine, blocking certain neuron fibers’ access to the brain and consequently the brain’s ability to sense the previously perceived pain. Patients who qualify for this procedure report up to a 70% reduction in pain.
The purpose of this study is to evaluate the effectiveness (how well the study drug works) of the study drug in people with leg pain due to a lumbar disc herniation and long-term safety. Traditionally, this type of pain is managed by either epidural steroid injections and physical therapy. In those patients where the pain disc injury is much too large to be managed with more conservative means, it will require surgery to manually go in and fix the disc to move it away from the nerves. The study drug (Condoliase) is being studied to see if it can be used as a potential alternative to surgery.
Participants will be monitored for 1 year after they are either given a single study drug treatment or a placebo. The placebo looks like the study drug treatment but does not contain any active ingredients.
Throughout the study you will have various tests and examinations done and will be asked questions about your overall quality of life, pain level of your leg and lower back, recent medications, injuries, and illnesses. In some circumstances, repeat tests and/or examinations (including laboratory, X-ray, and/or MRI tests) may be necessary.
This study is “double blinded,” which means that neither you nor the study doctor will know if you received the study drug or placebo. The study treatment you are given will be decided randomly, like tossing a coin. About 50% (half) of participants will receive the study drug treatment, and about 50% (half) will receive the placebo.
Currently, there are no FDA-approved medications to treat sciatica from disc herniations, so participants in the trial will be eligible to receive an experimental treatment not yet available to the rest of the public. Additionally, eligible patients will receive a small stipend for their time as well as reimbursement for qualified parking and travel costs associated with participation in the study.
The study drug might help the discomfort associated with lumbar disc herniation. Previous studies with the study drug showed a possible benefit in some patients. A beneficial effect cannot, however, be guaranteed, and you may not receive any direct personal benefits from being in this study. You will be given close attention from the study staff during the time you are involved in the study. You may receive information about your health from physical examinations and medical tests done in this study.
Your participation in this study may benefit the community, scientists, and doctors by providing increased knowledge and information about the treatment of lumbar disc herniation.
The clinical research team will discuss all study risks with you and answer any additional questions you may have.
You are free to leave the study at any time. If you leave the study before it is finished, there will be no penalty to you. You will not lose any benefits to which you may otherwise be entitled. Standard medical treatment you may receive will not be affected by withdrawing from the study.
Patients who qualify for the study will be randomized to receive either the experimental treatment (Condoliase) or a sham procedure. Patients will then be followed for 12-months to monitor their progress.
Study Enrollment Form
Official Protocol Name: A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)
Get Answers to Your Questions at the Ainsworth Institute
The key to finding the proper treatment for any type of pain is getting a proper diagnosis. Not all types of pain respond to the same treatments and the window for improvement can be limited. The experts at Ainsworth Institute offer the most advanced pain management treatments available today, including advanced clinical trials that aren’t yet available to the general public. Call us today for an appointment so we can get you started on your road to recovery.