Researchers Successfully Measure Treatment Effects on Patients’ Lives — ScienceDaily

Chronic pain and sleep are thought to be correlated, so treatment for one may benefit the other. One such treatment is spinal cord stimulation, which improves aspects of sleep and there is growing evidence that it has shown efficacy in treating a number of chronic pain conditions. This treatment includes an implantable spinal cord stimulator that sends low-level electricity directly to the spinal cord to relieve pain. However, the impact on patients’ lives has yet to be determined.

Researchers at Florida Atlantic University’s Schmidt School of Medicine, in collaboration with Albany Medical Center, conducted a study to better understand the effects of spinal cord stimulation on chronic pain and sleep.

In this study, participants completed a series of accredited outcome measures for sleep, pain, functional status, and overall quality of life at various time periods during the study. These investigations were performed preoperatively and 6 months or 1 year after surgery. Participants were also asked about their satisfaction with the spinal cord stimulation procedure and whether they would undergo surgery again.

Researchers examined relationships between pain outcome measures using the Insomnia Severity Index, a clinical screening tool that assesses the severity of both nighttime and daytime components of insomnia. Using this tool, we established the minimal clinically significant difference, that is, the smallest noticeable change that a patient perceives as clinically significant and may indicate a change in management. Minimal clinically important differences are particularly useful for evaluating new treatments due to the small cohorts to compare for statistical significance.

Research published in journals Stereotactic and functional neurosurgery, We successfully established a range of minimal, clinically important differences in the Insomnia Severity Index outcome measure to help measure improvement in insomnia after spinal cord stimulation.

The results showed that 39.1% of participants had an improvement of 30% or more on the Insomnia Severity Index, and 28.1% of participants had an improvement of 30% or more on the Epworth Sleepiness Scale. Minimum clinically important difference values ​​of 2.4 to 2.6 correlated with improvement in participants’ disability and depression. The study found associations between sleep and both pain and depression, but no correlation between sleep and spinal cord stimulation success.

“The physiological mechanisms of both pain and sleep are complex, and the relationship between the two is poorly understood,” said Julie Pilitsis, MD, Ph. .D. said. “Recognizing the intersection of sleep disturbances and chronic pain can lead to a more focused treatment plan, leading to significant improvements in overall health beyond improvements in sleep and pain alone.” I have.”

Successful spinal cord stimulation was measured by preoperative scores and changes in scores 6 to 12 months after surgery. For the Insomnia Severity Index, he asks seven questions to assess an individual’s level of insomnia, with higher scores indicating more trouble sleeping at night. The Epworth Sleepiness Scale quantifies daytime sleepiness based on a patient’s likelihood of falling asleep during her eight daily activities, with higher scores indicating increased daytime sleepiness. To determine which patients had improved sleep, researchers looked at her improvement of 30% or more on the Insomnia Severity Index or the Epworth Sleepiness Scale.

Pilitsis, who is also a member of the FAU Stiles-Nicholson Brain Institute, said, “In patients undergoing spinal cord stimulation, it is important to consider the interplay between sleep and chronic pain, so it is relevant for our study.” Sleep status was included in the analysis. “As more research is conducted on the threshold of minimal clinically important difference, it will improve the assessment of clinical response to spinal cord stimulation. Therefore, this treatment should be It allows us to better understand the types of patients who are most likely to benefit from

The co-author of the study is Phillip M. Johansen, a fourth-year medical student at FAU. Frank A. Trujillo, third year FAU medical school. Vivian Hagerty, MD, General Surgery Resident at FAU. FAU Schmidt Medical College. Neurosurgeon Tessa Harland, MD. and Gregory Davis, MD, both at Albany Medical Center.