Premium
Setting appropriate pain expectations: Lessons learned from a clinical trial
Author(s) -
Bonati Lauren M.,
Quatrano Nicola A.,
Sadeghpour Mona,
Arndt Kenneth A.,
Dover Jeffrey S.
Publication year - 2019
Publication title -
lasers in surgery and medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.888
H-Index - 112
eISSN - 1096-9101
pISSN - 0196-8092
DOI - 10.1002/lsm.23029
Subject(s) - physical therapy , rating scale , protocol (science) , medicine , clinical trial , set (abstract data type) , randomized controlled trial , medline , pain assessment , pain management , physical medicine and rehabilitation , psychology , alternative medicine , surgery , computer science , developmental psychology , pathology , political science , law , programming language
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.