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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Aalborg University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Active Comparator | 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. |
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| Suspected CP | Active Comparator | 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. |
|
| Definite CP | Active Comparator | 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. |
|
| Sphincter of Oddi Dysfunction or Functional Dyspepsia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One-time baseline testing |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Evans-Phillips, MD | Contact | 412-624-4560 | evansac3@upmc.edu | |
| Apsara Mishra | Contact | apm179@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anna Evans-Phillips, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Institutions | Recruiting | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37967828 | Derived | Phillips AE, Faghih M, Singh VK, Bick B, Yadav D, Drewes AM, Olesen SS. Widespread Hyperalgesia by Pancreatic Quantitative Sensory Testing Is Associated With Reduced Pain Response in Chronic Pancreatitis. Pancreas. 2023 Apr 1;52(4):e257-e258. doi: 10.1097/MPA.0000000000002247. Epub 2023 Nov 13. No abstract available. | |
| 34860815 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 3, 2018 | Jan 4, 2018 |
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Participants are assigned to one of four groups in parallel for the duration of the study based on prior clinical history.
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| Active Comparator |
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. |
|
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| 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. |
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| 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. |
|
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| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| Phillips AE, Faghih M, Singh VK, Olesen SS, Kuhlmann L, Novovic S, Bick B, Hart PA, Ramsey ML, Talukdar R, Garg PK, Yadav D, Drewes AM; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Rationale for and Development of the Pancreatic Quantitative Sensory Testing Consortium to Study Pain in Chronic Pancreatitis. Pancreas. 2021 Oct 1;50(9):1298-1304. doi: 10.1097/MPA.0000000000001912. |
| 34675068 | Derived | Olesen SS, Phillips AE, Faghih M, Kuhlmann L, Steinkohl E, Frokjaer JB, Bick BL, Ramsey ML, Hart PA, Garg PK, Singh VK, Yadav D, Drewes AM; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. Overlap and cumulative effects of pancreatic duct obstruction, abnormal pain processing and psychological distress on patient-reported outcomes in chronic pancreatitis. Gut. 2022 Dec;71(12):2518-2525. doi: 10.1136/gutjnl-2021-325855. Epub 2021 Oct 21. |
| 31787527 | Derived | Phillips AE, Faghih M, Kuhlmann L, Larsen IM, Drewes AM, Singh VK, Yadav D, Olesen SS; Pancreatic Quantitative Sensory Testing (P-QST) Consortium. A clinically feasible method for the assessment and characterization of pain in patients with chronic pancreatitis. Pancreatology. 2020 Jan;20(1):25-34. doi: 10.1016/j.pan.2019.11.007. Epub 2019 Nov 20. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D059350 | Chronic Pain |
| D046628 | Sphincter of Oddi Dysfunction |
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001657 | Biliary Dyskinesia |
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| D059227 | Postsynaptic Potential Summation |
| ID | Term |
|---|---|
| D009435 | Synaptic Transmission |
| D015398 | Signal Transduction |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D055366 | Synaptic Potentials |
| D008564 | Membrane Potentials |
| D002468 | Cell Physiological Phenomena |
| D055724 | Electrophysiological Phenomena |
| D010829 | Physiological Phenomena |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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