RecruitingNot ApplicableNCT03434392

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

Sponsor

Anna Evans Phillips

Enrollment

500 participants

Start Date

Oct 24, 2017

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Chronic Pancreatitis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria21

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.
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 Criteria17

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.
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.

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Interventions

DIAGNOSTIC_TESTQuantitative 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.

DIAGNOSTIC_TESTQuantitative 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.

DIAGNOSTIC_TESTQuantitative 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.