Setting appropriate pain expectations: Lessons learned from a clinical trial

Objective This retrospective study compares subject‐reported pain levels and expectations set forth by industry and treating physicians during a clinical trial of an energy based device. The physiologic and emotional aspects of pain expectations are discussed and recommendations are made for strategic patient counseling. Materials and Methods Average and mode pain scores were collected from the records of a previously conducted clinical trial investigating a radiofrequency microneedling device at three different settings. The trial protocol and device manual were reviewed to ascertain language regarding procedural pain. Treating physicians were asked how they learned about procedural pain and how they described it to subjects. Subject‐reported pain scores and verbal pain descriptors from the device manual and trial protocol were translated onto validated pain scales, the Numerical Rating Scale (NRS), and the Verbal Rating Scale (VRS), for comparison. Results A total of 90 procedural pain scores were collected from 30 subject charts. The average procedural pain scores for three different device settings were 5.3, 6.7, and 4.6 out of 10 and the mode pain score was 6 out of 10. This translated to a 5–6 and 7–8 on the NRS, respectively and classification as “painful but bearable” and “considerable pain” on the VRS. Industry sourced pain levels translated to a 2–4 on the NRS and classification as “little pain” on the VRS. Conclusion Subject‐reported pain scores were higher than those set forth by industry materials and personnel. Physicians should be wary of manufacturer materials or anecdotal evidence that might mislead patients and cause undue physiological or emotional stress. Lasers Surg. Med. 9999:XX–XX, 2018. © 2018 Wiley Periodicals, Inc.