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Active, Not Recruiting

NCT Number: NCT06996535

Pancreatic Quantitative Sensory Testing (P-QST)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Subjects with no pancreatic disease and no abdominal pain.

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.

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

Inclusion criteria

• Subjects are 5 years to 17 years old

  • 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 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.

Treatment and study plan

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.

Other names: Temporal Summation

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.

Other names: Segmental v Systemic Sensitization

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.

Other names: Conditioned Pain Modulation

Primary outcomes

  1. Pain Pattern Assessment

    Time frame: day 1

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Pancreatic Quantitative Sensory Testing (P-QST) in Pediatric Patients With Acute Recurrent Pancreatitis and Chronic Pancreatitis: Evaluation and Prediction of Treatment Response

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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