A Research Study For Lumbar Disc Herniation
Testing a One-Time Investigational Treatment for Low Back or Leg Pain
About the Study
The purpose of this study is to evaluate the effectiveness (how well the study drug works) and long-term safety of the study drug in people with leg pain due to a lumbar disc herniation. 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.
How might the study drug work?
The study drug treatment is a possible method by which the soft central portion of the herniated lumbar intervertebral disc is broken down or dissolved. As a result, the disc herniation may be reduced, and leg pain, lower back pain, and/or numbness may be improved.
Why Should I Participate?
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.
Am I Eligible?
A clinical research team member will help determine if you meet all necessary criteria to participate. These are not the only eligibility criteria for this clinical research study, and other criteria may exclude you.
You may be eligible to participate in this clinical study if you:
- Are between 30-70 years of age
- Have shooting pain, numbness or tingling in one leg
- Suspect your low back and/or leg pain is due to a lumbar herniated disc
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)
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.
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