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Pancreatic Quantitative Sensory Testing (P-QST)

NCT ID: NCT06996535

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2028-05-01

Brief Summary

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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.

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Detailed Description

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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 3, 6, and 12 months post-procedure for evaluation of changes in their pain profile.

Conditions

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Chronic Pancreatitis Chronic Pain Acute Recurrent Pancreatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Controls

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.

Quantitative Sensory Test 1

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Chronic Pancreatitis patients

Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires.

Quantitative Sensory Test 1

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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Quantitative 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Quantitative 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Temporal Summation Segmental v Systemic Sensitization Conditioned Pain Modulation

Eligibility Criteria

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Inclusion Criteria

* Subjects are 5 years to 17 years old
* Subject and or legal guardian is willing and able to comply with the scheduled visits, questionnaires, treatment plan, and other study procedures.
* 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 ARP or CP from chronic pain of other origins.


* Subjects will have a prior confirmed diagnosis of CP on CT scan or MRI/MRCP according to Cambridge Classification (grade 3 or 4)
* Subjects and or legal guardian willing and able to comply with the scheduled visits, questionnaires, and other study procedures.

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 that make them unable to distinguish the pain associated with ARP or CP from chronic pain of other origins.

Definite Chronic Pancreatitis


* 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 enrollment.
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan Gurria

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Childrens Hospital Medical Center

Locations

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Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2023-0046

Identifier Type: -

Identifier Source: org_study_id

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