Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
University of Pittsburgh
Study ID
NCT04996628
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quantitative Sensory Test 1 — DIAGNOSTIC_TEST
    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.
  • Quantitative Sensory Test 2 — DIAGNOSTIC_TEST
    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.
  • Quantitative Sensory Test 3 — DIAGNOSTIC_TEST
    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.

Study Details

Abdominal pain in chronic pancreatitis (CP) affects up to 90% of patients during the course of their disease, and response to currently available therapies is suboptimal and unpredictable. The proposed clinical trial will evaluate the predictive capability of Pancreatic Quantitative Sensory Testing (P-QST) - a novel assessment of neurosensory phenotyping- for improvement in pain in patients with CP who are undergoing medically-indicated invasive treatment with endoscopic therapy or surgery.

Key Dates

Start date
Jan 4, 2022
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Pancreatic Quantitative Sensory Testing (P-QST)
    Definite Chronic Pancreatitis patients undergoing decompressive invasive treatments (endoscopic therapy or surgery) to relieve main pancreatic duct obstruction due to stones and/or stricture for management of pain will undergo P-QST prior to clinically-indicated invasive treatment.

Primary Outcome Measure

Average Pain Score [ Time Frame: six months post procedure ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana University Medical CenterIndianapolisIndiana46202
Suzette Schmidt, RN
[email protected]
317-278-0691
Jeffrey Easler, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins Medical InstitutionsBaltimoreMaryland21287
Mahya Faghih, MD
[email protected]
410-614-6708
(Site) Vikesh K Singh, MD, MSc (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Anna E Phillips, MD, MS
[email protected]
412-647-2345
Anna E Phillips, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University Medical Center· Indianapolis, INJohns Hopkins Medical Institutions· Baltimore, MDUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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