QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
NCT ID: NCT03434392
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2017-10-24
2026-06-30
Brief Summary
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Detailed Description
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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 1, 3, and 6 months post-procedure for evaluation of changes in their pain profile.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Healthy Controls
Subjects 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.
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.
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.
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.
Suspected CP
Suspected 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.
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.
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.
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.
Definite CP
Definite 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.
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.
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.
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.
Sphincter of Oddi Dysfunction or Functional Dyspepsia
Patients 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.
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.
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
* Subjects are 18 years or older in age
* Subjects have prior diagnosis of Type 1 or Type 2 Sphincter of Oddi Dysfunction (subjects with biliary pain accompanied by biochemical features of transient biliary tract obstruction including elevated transaminases, alkaline phosphatase, or conjugated bilirubin; may also be accompanied by biliary or pancreatic ductal dilation on imaging)
* 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.
* Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
Exclusion Criteria
* 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.
* Subjects with known pregnancy at the time of enrolment.
* Subjects who have previously undergone surgical intervention on their pancreas.
18 Years
ALL
Yes
Sponsors
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Johns Hopkins University
OTHER
Aalborg University
OTHER
Anna Evans Phillips
OTHER
Responsible Party
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Anna Evans Phillips
Assistant Professor of Medicine
Principal Investigators
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Anna Evans-Phillips, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Johns Hopkins Medical Institutions
Baltimore, Maryland, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Mahya Faghih, M.D.
Role: primary
Anna Evans-Phillips, MD
Role: primary
References
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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.
Phillips 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.
Olesen 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.
Phillips 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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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PRO17060648
Identifier Type: -
Identifier Source: org_study_id