Clinical Trials for Spinal Stenosis
Many clinical trials for spinal stenosis are currently underway. Cervical (neck) and lumbar (low back) spinal stenosis are common in men and women age 50 and older, although it is possible to develop spinal stenosis earlier.
Past research studies about spinal stenosis have advanced the medical care patients receive. Some studies have investigated the outcomes of non-operative versus surgical treatment, effectiveness of epidural steroid injections, value of specific types of medications (eg, anti-inflammatory medications), minimally invasive surgical procedures that decompress fragile nerve roots, and novel devices that stabilize the facet joint.
Spinal Stenosis Clinical Trial Enrollment: How Does This Work?
Although clinical trials cannot function safely and efficiently without one or more Principal Investigators (eg, doctor who specializes in spinal stenosis), Clinical Trial Coordinators, nurses, patient advocates, and others—patient participants are also critical to the success of a research study.
Key to a patient’s enrollment as a clinical trial participant is meeting the study’s inclusion and exclusion criteria. The criteria are a formal set of rules that describe who is an ideal patient with spinal stenosis. The rules are different for each clinical trial because the purpose and goals of research studies vary. The criteria are part of the study’s strict regulations called its protocol (plan).
Carefully review a study’s inclusion and exclusion criteria before deciding to pursue participation in a spinal stenosis clinical trial.
Patient Safety Is Important in Spinal Stenosis Clinical Trials
Patient safety throughout a clinical trial is of primary importance. Every aspect of the design of a spinal stenosis clinical trial focuses on keeping participants safe.
Informed Consent is a written document that participants consider before voluntarily enrolling in a clinical trial. Informed Consent outlines the study’s purpose, duration, risks and potential benefits. The Informed Consent is not, however, a binding contract—a participant may withdraw from the research study anytime.