DENVER – There is an apparent disconnect between the level of periprocedural pain experienced by patients during vascular laser procedures and what device manufacturers say that level of pain should be, results from a retrospective study showed.
Dr. Lauren Bonati
“Although there is an abundance of research on how pain signals are transmitted in the nervous system and how pain is perceived among certain patient demographics, there is not much known about how pain perception differs from that put forth by industry,” Lauren Bonati, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “This study is unique because we are questioning not whether pain perception is reproducible between patients, but rather if it reflects what industry and device manufacturers are telling us.”
Dr. Bonati, a dermatologist at Edwards, Colo.–based Mountain Dermatology Specialists, and her colleagues collected median and mode pain scores from a past clinical trial that investigated a dual wavelength laser used for different types of treatments. “The treatment type (laser wavelength and treatment area) was largely based on the severity of facial redness for each individual patient,” she explained. “The options were spot treatment, nose and cheeks, or a global facial treatment with either wavelength.” The researchers reviewed industry-provided materials to determine language regarding procedural pain, and they interviewed the clinical trial’s principal investigator about how pain expectations were set during the trial. Next, they transferred subject-reported pain scores and verbal pain descriptors to the validated Numerical Rating Scale and the Verbal Rating Scale, for comparison.
In all, 85 procedural pain scores were collected from 22 subject charts. The researchers found that the average procedural pain scores for treatment types reported by subjects were translated to entirely different verbal and numerical categories of pain from those described by industry materials. “It was surprising to see how vague pain descriptions can be in device manuals and industry materials, if even addressed at all,” Dr. Bonati said.
She advised clinicians to be wary of whom they rely on for information related to pain expectations. “Also, remember that wrongly set pain expectations can have physiologic and emotional effects that may positively or negatively impact patient experience,” Dr. Bonati said.
She acknowledged certain limitations of the study, including the fact that it was a review of a previously conducted clinical trial, “which is not a perfect representation of real-life clinic.”
She reported having no conflicts of interest.