NCT06996535

Pancreatic Quantitative Sensory Testing (P-QST)

Pancreatic Quantitative Sensory Testing (P-QST) in Pediatric Patients With Acute Recurrent Pancreatitis and Chronic Pancreatitis: Evaluation and Prediction of Treatment Response

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Accepted

Summary

Quantitative Sensory Testing (QST) is a novel investigative technique used in other pain conditions to evaluate patterns of chronic pain, and in this study will be used to elucidate pain patterns in patients with Chronic Pancreatitis (CP). QST uses a specific series of standardized stimulations to map the pain system. QST has the potential to change and improve the treatment paradigm for patients with CP and may eventually be able to predict response to invasive CP therapies.

Detailed description

In Chronic Pancreatitis (CP), clinical pain symptoms correlate poorly with pancreatic ductal morphology, response to endoscopic or surgical therapy is unpredictable, and the rationale for invasive therapies is often questioned. Quantitative sensory testing (QST) is a technique used to map the pain system based on the rationale that different neural pathways and networks can be explored using standardized stimulation and simultaneous recording of the evoked pain response by psychophysical and/or objective methods. In this study, the investigators aim to distinguish phenotypes characterized by segmental sensitization of the pancreatic viscerotome, and systemic sensitization with pathological central pain processing. The investigators will perform QST on controls and CP subjects consisting of stimulation in several different dermatomes including pancreatic and control areas. All subjects will also answer standardized questionnaires assessing pain, depression, anxiety, and quality of life at baseline. Subjects undergoing endoscopic or surgical therapy will also undergo follow-up testing consisting of the same tests at 3, 6, and 12 months post-procedure for evaluation of changes in their pain profile.

Conditions

• Chronic Pancreatitis
• Chronic Pain
• Acute Recurrent Pancreatitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Quantitative Sensory Test 1	Subject will give pain rating (on Visual Analogue Scale (VAS) 0-10) of single as well as multiple stimulation with round-tip non-invasive pin-prick device. Difference is recorded as Temporal Summation Score.
DIAGNOSTIC_TEST	Quantitative Sensory Test 2	Subject will state when they first detect pain and pain detection threshold in response to pressure administration with pressure algometer. Pressure threshold recorded in kilopascals(kP). Stimulation will be repeated in pancreatic and control dermatomes. Subject will then state pain tolerance threshold at same locations. Sensitization will be characterized by ratio of pancreatic vs. control dermatome scores.
DIAGNOSTIC_TEST	Quantitative Sensory Test 3	Subject will apply dominant hand to ice-chilled water bath (36F) for up to 2 minutes. Pain score (VAS 0-10) will be assessed each 10 seconds. Pain tolerance threshold (in kP) will be assessed with algometer on non-dominant thigh before and after water bath to determine change in threshold. Difference in pain tolerance recorded as Conditioned Pain Modulation Score.

Timeline

• Start date: 2024-08-01
• Primary completion: 2028-03-01
• Completion: 2028-05-01
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States