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

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ClinicalTrials.gov Identifier: NCT03434392
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Collaborators:
Johns Hopkins University
Aalborg University
Information provided by (Responsible Party):
Dhiraj Yadav, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Chronic Pain Diagnostic Test: Quantitative Sensory Test1 Diagnostic Test: Quantitative Sensory Test 2 Diagnostic Test: Quantitatie Sensory Test 3 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of four groups in parallel for the duration of the study based on prior clinical history.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Healthy Controls

Subjects with no pancreatic disease and no abdominal pain.

Subjects will undergo the following Interventions: QST tests 1, 2, and 3.

They will also fill out validated questionnaires.

Diagnostic Test: Quantitative Sensory Test1
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 Name: 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 Name: Segmental v Systemic Sensitization

Diagnostic Test: Quantitatie 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 Name: Conditioned Pain Modulation

Active Comparator: Suspected CP

Suspected Chronic Pancreatitis patients.

Subjects will undergo the following Interventions: QST tests 1, 2, and 3.

They will also fill out validated questionnaires.

Diagnostic Test: Quantitative Sensory Test1
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 Name: 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 Name: Segmental v Systemic Sensitization

Diagnostic Test: Quantitatie 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 Name: Conditioned Pain Modulation

Active Comparator: Definite CP

Definite Chronic Pancreatitis patients.

Subjects will undergo the following Interventions: QST tests 1, 2, and 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 QST tests 1, 2, and 3 and questionnaires.

Diagnostic Test: Quantitative Sensory Test1
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 Name: 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 Name: Segmental v Systemic Sensitization

Diagnostic Test: Quantitatie 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 Name: 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: QST tests 1, 2, and 3.

They will also fill out validated questionnaires.

Diagnostic Test: Quantitative Sensory Test1
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 Name: 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 Name: Segmental v Systemic Sensitization

Diagnostic Test: Quantitatie 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 Name: Conditioned Pain Modulation




Primary Outcome Measures :
  1. 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 Temporal Summation score, Sensitization score, and Conditioned Pain Modulation score to be recorded in all patients on enrollment. Patients will be grouped according to whether these scores are inside or outside of 95% Confidence Interval of Mean Scores of Control patients.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434392


Contacts
Contact: Anna E Phillips, MD 412-624-4560 evansac3@upmc.edu
Contact: Laura Mathews 412-624-3096 ljm96@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Anna E Phillips, MD    412-624-4560    evansac3@upmc.edu   
Sub-Investigator: Anna E Phillips, MD         
Sponsors and Collaborators
Dhiraj Yadav
Johns Hopkins University
Aalborg University
Investigators
Principal Investigator: Dhiraj Yadav, MD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Dhiraj Yadav, University of Pittsburgh:
Study Protocol  [PDF] January 3, 2018


Responsible Party: Dhiraj Yadav, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03434392     History of Changes
Other Study ID Numbers: PRO17060648
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dhiraj Yadav, University of Pittsburgh:
Chronic Pain
Chronic Pancreatitis
Sphincter of Oddi Dysfunction
Recurrent Acute Pancreatitis
Chronic Abdominal Pain
Functional Dyspepsia

Additional relevant MeSH terms:
Chronic Pain
Pancreatitis
Pancreatitis, Chronic
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pancreatic Diseases
Digestive System Diseases