Everything You Need to Know: Clinical Trials for Spinal Stenosis
Spinal stenosis is a narrowing of the spinal canal, which can put pressure on the spinal nerves to cause numbness and pain. Numerous clinical trials to explore advanced treatment options for spinal stenosis are underway. Participants in these trials are critical to enabling researchers to find ways to provide better patient care. Before signing up for a clinical trial, it is essential to understand what you’re getting into and whether participating is the right course of action for you and your diagnosis.
What Is a Clinical Trial?
The purpose of clinical trials is to discover innovative ways to prevent a disease, introduce new methods to treat a disease, pilot new medical technologies or offer support for ill patients. Researchers use clinical trials to study whether an intervention (treatment remedy) is safe and effective. They also investigate the possibility of using existing drugs to offer relief for specific conditions for which the drugs may not currently be approved by the Food and Drug Administration (FDA). Medical companies use clinical trials to validate their new products’ safety and effectiveness before they can be approved and released for public consumption. In short, clinical trials are an effective, widespread way to vet the safety and efficacy of medical advances. There are multiple clinical trials available for anyone living with spinal stenosis. Cervical (neck) and lumbar (lower back) spinal stenosis cases are frequently seen in men and women over 50 years old, however, many younger people receive this diagnosis as well. Topics of spinal stenosis clinical trials have included:
- Non-invasive treatment versus surgery
- Epidural steroid injections
- Medications (i.e., anti-inflammatory medications, narcotics, or new drugs not yet released to the public)
- Minimally invasive surgical procedures that decompress fragile nerve roots
- Innovative devices that secure the facet joints in place
Am I Eligible?
Before you sign up for a clinical trial, ensure you meet the guidelines, including your availability to participate during the hours and dates of the trial. Factors that qualify you as an acceptable candidate are called inclusion criteria while those that preclude your ability to participate are called exclusion criteria. These factors are based on age, gender, the type and stage of a disease, previous treatment history, and other medical conditions, according to National Institutes of Health (NIH).
Are There Rules?
The rules vary for each clinical trial because the purpose and goals of the research differ from study to study. The criteria are part of the study’s stern ordinances — referred to as the protocol plan — that protect the participants’ health and answer specific research questions. The NIH describes a protocol as follows:
- Who is eligible to participate in the trial
- Details about tests, procedures, medications, and dosages
- The length of the study and what information will be gathered
- A principal investigator (PI), usually a certified doctor, oversees the clinical study. Members of the research team — including clinical trial coordinators, nurses and patient advocates — frequently review the candidate’s medical history to assess the study’s safety and effectiveness.
Conduct a thorough review of a study’s inclusion and exclusion criteria before signing up for a spinal stenosis clinical trial.
Your safety during a spinal stenosis clinical trial is always top priority. Most trials are run on a volunteer basis, so you have the option to leave if you cannot stay until completion for any reason. However, if you feel sick from possible side effects of medications or you simply are not confident in the treatments being tested, you can end your participation.
Prior to intentionally entering the clinical trial, you will sign an Informed Consent Document, which details the study’s end goal, time, potential risks and possible benefits. The Informed Consent document is not a binding contract; it serves as a written acknowledgement that you understand the ramifications of your participation. So, Backers, have you ever considered participating in a clinical trial?