QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
1 other identifier
interventional
500
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 24, 2017
CompletedFirst Submitted
Initial submission to the registry
November 3, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 18, 2025
December 1, 2025
8.7 years
November 3, 2017
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Pattern Assessment as assessed by the combination of Temporal Summation score, Sensitization score, and Conditioned Pain Modulation score
Assignment to one of four groups (Segmental Sensitization, Systemic Sensitization, Impaired Conditioned Pain Modulation, or Other) based on combination of patient-reported pain symptoms. Temporal summation pain symptoms are measured on visual analogue scales which are measured from 0 (minimum) to 10 (maximum). 10 on this scale indicates worse pain; 0 indicates no pain. Sensitization scores are measured via patient reported thresholds in kilopascals. Conditioned Pain modulation is measured also via patient reported threshold in kilopascals.
One-time baseline testing
Secondary Outcomes (1)
Change in Mean Pain score
90 days
Study Arms (4)
Healthy Controls
ACTIVE COMPARATORSubjects with no pancreatic disease and no abdominal pain. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires.
Suspected CP
ACTIVE COMPARATORSuspected Chronic Pancreatitis patients. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires.
Definite CP
ACTIVE COMPARATORDefinite Chronic Pancreatitis patients. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires. A subset of these patients who undergo endotherapy as per clinical recommendation from clinical provider independent of this study will be followed for 6 months after their clinical intervention for repeat Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3 and questionnaires.
Sphincter of Oddi Dysfunction or Functional Dyspepsia
ACTIVE COMPARATORPatients with Sphincter of Oddi Dysfunction Type 1 or Type 2, or who have a prior diagnosis of Functional Dyspepsia. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Subjects with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.
- Subjects are 18 years or older in age
- Subjects must be able to read and understand the study information.
- Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subject is willing and able to comply with the scheduled visits, questionnaires, treatment plan, and other study procedures.
- Subjects are 18 years or older in age
- Subjects with a) Indeterminate CP (Cambridge 1 or 2 on CT scan or MRI/MRCP) who have abdominal pain without prior history of AP, or b) those with acute (AP) or recurrent acute pancreatitis (RAP) who have recovered from their attack(s) of AP, whose imaging studies are either normal or show changes consistent with Cambridge classification of 1 or 2, and they have ongoing abdominal pain. Both diabetic and non-diabetic subjects will be allowed to enter the study.
- Subjects must be able to read and understand the study information.
- Subjects must suffer from abdominal pain suspected to be pancreatic origin with an intensity above 3 on the visual analogue scale (VAS, where 0=no pain and 10= intolerable pain), and meet the criteria for chronic pain (pain ≥ 3 days per week for at least 3 months).
- Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
- Subjects are 18 years or older in age
- Subjects will have a prior confirmed diagnosis of CP on CT scan or MRI/MRCP according to Cambridge Classification (grade 3 or 4). Both diabetic and non-diabetic subjects will be allowed to enter the study.
- Subjects must be able to read and understand the study information.
- Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- +6 more criteria
You may not qualify if:
- Subjects with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.
- Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- Subjects suffering from painful conditions that make them unable to distinguish the pain associated with CP from chronic pain of other origins.
- Subjects with known pregnancy at the time of enrolment.
- Subjects who have previously undergone surgical intervention on their pancreas.
- Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- Subjects suffering from painful conditions other than pancreatitis or SOD type 1 or 2 that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
- Subjects with known pregnancy at the time of enrolment.
- Subjects who have previously undergone surgical intervention on their pancreas.
- Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- Subjects suffering from painful conditions other than pancreatitis or SOD type 1 or 2 that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
- Subjects with known pregnancy at the time of enrolment.
- Subjects who have previously undergone surgical intervention on their pancreas.
- Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- Subjects suffering from painful conditions other than pancreatitis or SOD that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anna Evans Phillipslead
- Johns Hopkins Universitycollaborator
- Aalborg Universitycollaborator
Study Sites (2)
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (4)
Phillips AE, Faghih M, Singh VK, Bick B, Yadav D, Drewes AM, Olesen SS. Widespread Hyperalgesia by Pancreatic Quantitative Sensory Testing Is Associated With Reduced Pain Response in Chronic Pancreatitis. Pancreas. 2023 Apr 1;52(4):e257-e258. doi: 10.1097/MPA.0000000000002247. Epub 2023 Nov 13. No abstract available.
PMID: 37967828DERIVEDPhillips AE, Faghih M, Singh VK, Olesen SS, Kuhlmann L, Novovic S, Bick B, Hart PA, Ramsey ML, Talukdar R, Garg PK, Yadav D, Drewes AM; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Rationale for and Development of the Pancreatic Quantitative Sensory Testing Consortium to Study Pain in Chronic Pancreatitis. Pancreas. 2021 Oct 1;50(9):1298-1304. doi: 10.1097/MPA.0000000000001912.
PMID: 34860815DERIVEDOlesen SS, Phillips AE, Faghih M, Kuhlmann L, Steinkohl E, Frokjaer JB, Bick BL, Ramsey ML, Hart PA, Garg PK, Singh VK, Yadav D, Drewes AM; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Overlap and cumulative effects of pancreatic duct obstruction, abnormal pain processing and psychological distress on patient-reported outcomes in chronic pancreatitis. Gut. 2022 Dec;71(12):2518-2525. doi: 10.1136/gutjnl-2021-325855. Epub 2021 Oct 21.
PMID: 34675068DERIVEDPhillips AE, Faghih M, Kuhlmann L, Larsen IM, Drewes AM, Singh VK, Yadav D, Olesen SS; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. A clinically feasible method for the assessment and characterization of pain in patients with chronic pancreatitis. Pancreatology. 2020 Jan;20(1):25-34. doi: 10.1016/j.pan.2019.11.007. Epub 2019 Nov 20.
PMID: 31787527DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Evans-Phillips, MD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
November 3, 2017
First Posted
February 15, 2018
Study Start
October 24, 2017
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share