The perception of procedural vascular laser pain and discrepancies amongst patients, physicians, and industry

BACKGROUND: The inherent subjectivity of pain perception makes pre-procedural pain counseling especially challenging. Setting the wrong pain expectations will negatively impact the patient's experience and affect their physiologic and emotional state. Best practices for sourcing pain related information about a given procedure, however, remains understudied. This retrospective study explores the accuracy of industry materials for describing procedural pain in a clinical trial when compared to subject reported pain scores from the same clinical trial. METHODS: Median and mode pain scores were collected from the data of a past clinical trial investigating a dual wavelength laser used for 4 different types of treatments. Industry provided materials were reviewed to ascertain language regarding procedural pain. The principal investigator was interviewed about setting pain expectations during the trial. Subject-reported pain scores and verbal pain descriptors were transferred to validated pain scales, the Numerical Rating Scale and the Verbal Rating Scale, for comparison. RESULTS: A total of 85 procedural pain scores were collected from 22 subject charts. The average procedural pain scores for 3 of 4 treatment types reported by subjects were translated to entirely different verbal and numerical categories of pain than that described by industry materials. CONCLUSIONS: Industry materials failed to capture the range of procedural pain scores reported by subjects for 3 of 4 treatment types in a clinical trial setting. When counseling patients on procedural pain, physicians should take extra care to not mislead patients and cause undue physiological or emotional stress.