Setting appropriate pain expectations: Lessons learned from a clinical trial.

Area of Science:

• Dermatology and Aesthetic Medicine
• Clinical Trial Methodology
• Pain Management

Background:

• Investigates discrepancies between subject-reported pain and industry-set expectations in a radiofrequency microneedling clinical trial.
• Analyzes pain descriptors from device manuals, trial protocols, and physician interviews.
• Compares subject pain scores to industry-provided pain level expectations using validated scales.

Discussion:

• Subject pain scores (average 4.6-6.7/10, mode 6/10) translated to "painful but bearable" to "considerable pain" on the Verbal Rating Scale (VRS).
• Industry pain expectations translated to "little pain" (NRS 2-4) on the VRS.
• Highlights a significant gap between perceived and actual procedural pain.

Key Insights:

• Subject-reported pain consistently exceeded industry-communicated pain levels.
• Physicians must critically evaluate manufacturer materials to avoid misleading patients.
• Managing patient expectations is crucial for minimizing physiological and emotional distress during procedures.

Outlook:

• Recommends strategic patient counseling to align expectations with realistic pain experiences.
• Suggests refining communication strategies regarding procedural pain in clinical trials.
• Emphasizes the importance of accurate pain reporting for patient safety and trial integrity.