QST Study: Predicting Treatment Response in Chronic Pancreatitis

This study is looking at how different types of pain are experienced by people with chronic pancreatitis (CP) and those without pancreatic disease. It uses special tests called Quantitative Sensory Tests (QST) to understand your pain patterns. These tests involve rating your pain from single and repeated pin-prick stimulations, telling when you first feel pain from pressure, and how you react to holding your hand in ice-chilled water. The goal is to see if these pain patterns can help predict how well treatments for CP might work in the future. The study plans to enroll 500 participants and is open to adults aged 18 and older who can understand the study information.

Study design
This interventional study plans to enroll 500 participants. It uses diagnostic tests to understand pain patterns in people with and without chronic pancreatitis.
What's involved
You would undergo three Quantitative Sensory Tests involving pin-prick, pressure, and cold water stimulation. You would also complete questionnaires about pain, depression, anxiety, and quality of life at the start of the study.
Compensation
Not stated in the trial record.
Follow-up
If you undergo endoscopic or surgical therapy, you will have follow-up testing at 1, 3, and 6 months after your procedure.

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NCT03434392

QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing

Recruiting
NAAges 18+InterventionalDiagnostic
Anna Evans Phillips
~500 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Quantitative Sensory Test 1Quantitative Sensory Test 2Quantitative Sensory Test 3

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Pattern Assessment as assessed by the combination of Temporal Summation score, Sensitization score, and Conditioned Pain Modulation score
Measured over One-time baseline testing
Chronic Pancreatitis
Chronic Pain
2 sites across 2 states
Maryland1
Pennsylvania1
  • Anna Evans-Phillips, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

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Eligibility criteria

Inclusion

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

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.
  • Pain Pattern Assessment as assessed by the combination of Temporal Summation score, Sensitization score, and Conditioned Pain Modulation scoreOne-time baseline testing

    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.