An interventional study of Quantitative Sensory Test 1 and Quantitative Sensory Test 2 in Chronic Pancreatitis and Chronic Pain, sponsored by Anna Evans Phillips. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Anna Evans Phillips · Not applicable, Interventional, and Diagnostic
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.
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.
264 studies on the registry are indexed under Pancreatitis, Chronic; 76 are open to participants now.
This study's planned enrollment of 500 is above the median of 45 across 143 interventional studies indexed under Pancreatitis, Chronic.
Browse Pancreatitis, Chronic studies →Anna Evans Phillips is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.
Suspected CPs Inclusion Criteria
Definite Chronic Pancreatitis - Inclusion Criteria
Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 Inclusion Criteria
Exclusion Criteria:
Subjects with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.
Suspected CPs Exclusion Criteria
Definite Chronic Pancreatitis Exclusion Criteria
Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Diagnostic Test: Quantitative Sensory Test 2 · Diagnostic Test: Quantitative Sensory Test 3
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 · Diagnostic Test: Quantitative Sensory Test 2 · Diagnostic Test: Quantitative Sensory Test 3
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 · Diagnostic Test: Quantitative Sensory Test 2 · Diagnostic Test: Quantitative Sensory Test 3
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 · Diagnostic Test: Quantitative Sensory Test 2 · Diagnostic Test: Quantitative Sensory Test 3
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.
Also known as: Temporal Summation
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.
Also known as: Segmental v Systemic Sensitization
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.
Also known as: Conditioned Pain Modulation
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
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
Plan to share: No
Started Oct 2017 (actual). Primary completion is estimated for Jun 2030, 152 months after the start.
Of 46 non-industry interventional studies with no phase under Pancreatitis, Chronic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 64. This study's planned 152 months is above that.
Counting every sponsor, half of 49 studies reached it within 32 months; a quarter within 18 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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Anna Evans Phillips