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

ConditionsChronic Pancreatitis Chronic Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAnna Evans Phillips

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Quantitative Sensory Test 1
Diagnostic test
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
Diagnostic test
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
Diagnostic test
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.

Treatment groups

500 Participants

are divided into 4 treatment groups

Group A: Healthy ControlsActive comparator 3 interventions

Group B: Suspected CPActive comparator 3 interventions

Group C: Definite CPActive comparator 3 interventions

Group D: Sphincter of Oddi Dysfunction or Functional DyspepsiaActive comparator 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

One-time baseline testing

Secondary outcomes

Change in Mean Pain score

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.

Time frame

90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anna Evans Phillips

Lead sponsor

University of Pittsburgh

Sponsor institution

Johns Hopkins University

Collaborator

Aalborg University