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

November 7, 2023 updated by: Anna Evans Phillips
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 1, 3, and 6 months post-procedure for evaluation of changes in their pain profile.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Medical Center
        • Contact:
        • Principal Investigator:
          • Benjamin Lo Bick, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Medical Institutions
        • Contact:
        • Principal Investigator:
          • Vikesh K. Singh, M.D.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Sub-Investigator:
          • Dhiraj Yadav, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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.

  2. Suspected CPs Inclusion Criteria

    • 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.

  3. Definite Chronic Pancreatitis - Inclusion Criteria

    • 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.

  4. Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 Inclusion Criteria

    • 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:

  1. 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.

  2. Suspected CPs 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 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.

  3. Definite Chronic Pancreatitis 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 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.

  4. Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Other Names:
  • Temporal Summation
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.
Other Names:
  • Segmental v Systemic Sensitization
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.
Other Names:
  • Conditioned Pain Modulation
Active Comparator: 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.
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.
Other Names:
  • Temporal Summation
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.
Other Names:
  • Segmental v Systemic Sensitization
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.
Other Names:
  • Conditioned Pain Modulation
Active Comparator: 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.
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.
Other Names:
  • Temporal Summation
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.
Other Names:
  • Segmental v Systemic Sensitization
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.
Other Names:
  • Conditioned Pain Modulation
Active Comparator: 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.
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.
Other Names:
  • Temporal Summation
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.
Other Names:
  • Segmental v Systemic Sensitization
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.
Other Names:
  • Conditioned Pain Modulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Pattern Assessment as assessed by the combination of Temporal Summation score, Sensitization score, and Conditioned Pain Modulation score
Time Frame: One-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.
One-time baseline testing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Pain score
Time Frame: 90 days
In Definite CP Patients undergoing endotherapy as part of regular clinical care, assessment of mean pain level for 7 days prior to endotherapy will be assessed immediately pre-procedure and again at 90 days post-procedure. A pain reduction of >30% in 90 days after procedure will be characterized as positive response to procedure.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Evans Phillips

Collaborators

Johns Hopkins University
Aalborg University

Investigators

  • Principal Investigator: Anna Evans-Phillips, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2017

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO17060648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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