Interrater Reliability of a Manual Diagnostic Protocol for Pancreatic Functional Visceral Dysfunction

Area of Science:

• Gastroenterology and Hepatology
• Pain Medicine
• Diagnostic Accuracy Studies

Background:

• Manual examination lacks validated diagnostic tools for nociplastic visceral pain.
• Functional pancreatic visceral dysfunction requires reliable diagnostic methods.
• Nociplastic pain presents diagnostic challenges in visceral conditions.

Purpose of the Study:

• To establish interrater reliability of a manual examination protocol for functional pancreatic visceral dysfunction.
• To define clinical criteria for manual palpatory diagnosis of nociplastic visceral pain.
• To assess the reliability of palpation-based criteria and the Verbal Numerical Rating Scale (vNRS) in pancreatic pain assessment.

Main Methods:

• A double-blind, cross-sectional study with 60 participants and three raters.
• Evaluation of five palpation-based criteria: local pain, referred pain, neurovegetative symptoms, hyperalgesia/allodynia, and tissue resistance/density.
• Measurement of interrater agreement using percentage agreement and Fleiss' kappa; vNRS reliability assessed with ICC.

Main Results:

• High interrater agreement (Fleiss' kappa > 0.86) for local pain, neurovegetative symptoms, and hyperalgesia/allodynia.
• Substantial agreement (Fleiss' kappa > 0.67) for referred pain and tissue resistance/density.
• Excellent reliability (ICC > 0.90) for vNRS scores across pancreatic regions (head, body, tail).

Conclusions:

• Three blinded raters achieved near-perfect interrater agreement for functional visceral dysfunction in the pancreas.
• The manual diagnostic protocol demonstrates reliability and potential utility for diagnosing nociplastic pancreatic pain.
• Further research is recommended to validate the diagnostic accuracy of this manual protocol for nociplastic visceral pain.