Clinical Trials for Back Pain
Elizabeth Shane Creighton University
Washington University School of Medicine
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Utah
Many clinical trials are actively recruiting patients with back pain. While the term back pain is often used in a generic sense, and broadly describes a spine problem or backache, a clinical trial uses precise medical terms to describe the type of back pain appropriate for the study. The type of patient with back pain is defined in the study’s inclusion criteria—a part of the standards by which a patient is selected to participate in a clinical trial.
Sample Criteria for Back Pain Clinical Trials
- The clinical trial coordinator requires patients with a low back (lumbar) spine problem that was previously diagnosed by a doctor. Degenerative disc disease, spondylolisthesis, and spinal stenosis are examples of lumbar disorders.
- The study candidate’s previous and current medical history yields much information: age, co-existing diseases (eg, osteoporosis), neurologic symptoms (eg, extremity weakness), and responses to treatments tried.
- The clinical trial may specify that only patients with chronic back pain and radiculopathy (eg, leg pain) be enrolled.
Clinical trials for back pain also include exclusion criteria. This means a candidate with back pain may satisfy all the qualifying criteria, and yet be excluded from clinical trial participation for one or more reasons (eg, pregnancy or active infection). The purpose of inclusion and exclusion criteria is to gather patients with similar back pain.
The criteria are also important to help maintain patient safety and treatment efficacy (how well the treatment works, which is typically what clinical trials are studying).
Perhaps you are considering participation in a clinical trial studying back pain, its diagnosis, or treatment. If so, be assured that your interest and participation can help advance the understanding and treatment of back pain and its myriad symptoms.