Pregabalin may not be effective for off-label treatment of spinal stenosis

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A team of researchers from the University of Rochester Department of Neurosurgery asserted that pregabalin, which is sold under the name Lyrica, is not effective as an off-label prescription treatment for spinal stenosis of the lumbar spine, as published in the journal Neurology. These results underscore the importance of more effective therapeutic strategies for the spinal condition, as well as detailed descriptions of disease progression and patient outcomes within orthopedic​ EMR software.

"Chronic low back pain is one of the most common reasons why older adults go to the doctor and lumbar stenosis is the leading indication for surgery in this age group," lead author John Markman, M.D., director of the Translational Pain Research Program at UR, said in a statement. "While physicians have increasingly looked for medication alternatives to opioid pain medication like gabapentin and pregabalin to help these patients manage their pain, until now there has been no credible evidence as to whether or not these treatments are effective for this problem."

Conservative and surgical treatments are available
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, patients who are diagnosed with spinal stenosis experience pain, numbness, weakness, cramps and other symptoms because of abnormal narrowing of the spinal column. This may be the result of spinal tumors, traumatic injury or genetic conditions, such as achondroplasia. However, the most common cause of spinal stenosis is structural degeneration during the aging process, which leads to diseases like osteoarthritis.

Conservative treatments for spinal stenosis of the lumbar spine include non-steroidal anti–inflammatory drugs, analgesics, corticosteroids and spinal injections with anesthesia. Additionally, patients may benefit from range-of-motion exercises for the spine or back support devices. In extreme cases, surgery may be needed to relieve the pressure on the nerves of the spinal cord. According to the UR researchers, surgery is not appropriate for all patients, and in some cases, pain returns after an initially successful few years.

Some health care providers have resorted to off-label prescription of pregabalin, which the National Institutes of Health describes as an anticonvulsant that decreases the amount of pain signals that come from damaged nerves. The U.S. Food and Drug Administration approved pregabalin for the treatment of conditions such as fibromyalgia, diabetic neuropathy and shingles.

The purpose of the UR study published in Neurology is to assess the impact of pregabalin as a medication for lumbar spinal stenosis patients.

Study 'demonstrates a lack of relief'
To find out more about whether pregabalin is of any value among individuals diagnosed with lumbar spinal stenosis, the researchers from UR conducted an experiment in which patients living with the condition underwent walking treadmill tests, then reported on their levels of pain. While some of these study subjects were taking pregabalin, others were on placebos. Results showed that the levels of pain experienced by patients did not differ, regardless of  the drug they received.

These results are important in light of the fact that ineffective treatment can inflate medical costs, drive disease progression and cause side effects. According to the NIH, the side effects of pregabalin include fatigue, dizziness, nausea, vomiting, confusion, anxiety and, in extreme cases, hives, chest pain, shortness of breath and muscle pain.

"This study convincingly demonstrates a lack of relief with pregabalin for the walking pain associated with lumbar spinal stenosis," Markman said.

Analysis of individual patients orthopedic EMR records will help providers gain a better understanding of what treatment strategies are worth trying. If pregabalin does not work, doctors may want to consider other conservative, non-invasive forms of therapy.