Pancreatic Quantitative Sensory Testing (P-QST)

NCT06996535 | Active Not Recruiting

• 1 other identifier: 2023-0046
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pancreatitis; Chronic Pain; Acute Recurrent Pancreatitis

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• Pain Pattern Assessment

  Pain Pattern Assessment as assessed by the combination of Temporal Summation score, Sensitization score, and Conditioned Pain Modulation score

  day 1

Study Arms (2)

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.

Diagnostic Test: Quantitative Sensory Test 1; Diagnostic Test: Quantitative Sensory Test 2; Diagnostic Test: Quantitative Sensory Test 3

Chronic Pancreatitis patients

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

Interventions

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.

Also known as: Temporal Summation

Chronic Pancreatitis patients; Healthy Controls

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.

Also known as: Segmental v Systemic Sensitization

Chronic Pancreatitis patients; Healthy Controls

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.

Also known as: Conditioned Pain Modulation

Chronic Pancreatitis patients; Healthy Controls

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Stratified Sampling

You may qualify if:

• 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.

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Chronic Pain

Interventions

Postsynaptic Potential Summation

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Synaptic Transmission; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Synaptic Potentials; Membrane Potentials; Cell Physiological Phenomena; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juan Gurria

  Cincinnati Childrens Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: May 30, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)