Pain Phenotypes in Chronic Pancreatitis

NCT05713344 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-02-08

No results posted yet for this study

Summary

Chronic pancreatitis (CP) is characterised by recurrent abdominal pain. The pathological hallmarks of CP is pancreatic stellate cell activation that results in persistent inflammation and progressive fibrosis. It has been shown in various clinical and experimental studies that with disease progression there could be pancreatic neural inflammation, spinal sensitization and eventually alteration in the pain modulating architecture within the brain (widespread sensitization). These events result in different types of pain (nociceptive and neuropathic) in patients with CP, which may dynamically change during disease progression.

Since the treatment for different mechanisms are unique, it becomes important to identify the predominant type of pain. Recently, pancreatic quantitative sensory testing (P-QST) has emerged as a valuable tool to identify different types of sensitization. This facility is currently available only in select centers and is being conducted under research protocols.

In this study, we propose to: 1. evaluate the patterns of pain in CP and the triggers; 2. identify clinical surrogates of sensitization, i.e. neuropathic pain.

The ultimate goal is to apply the best possible pain management strategy based on our research findings for patients with CP in a personalised manner.

Conditions

  • Chronic Pancreatitis

Interventions

OTHER

Clinical history

Detailed clinical history including demographic details, pain details (character, pattern, location, change in character, involvement of new areas), duration of disease, co-morbidities, family history, adverse life events, sleep details, details of stress/anxiety.

OTHER

Clinical examination

Thorough clinical examination, anthropometric measurement, assessment of pain (Izbicki score, Visual analog scale, modified brief pain inventory, pain catastrophising score, painDetect)

OTHER

Evaluation of quality of life

Use of the EORTC QLQ c30 with PAN 28 to evaluate quality of life

OTHER

Evaluation of mental state

Use of Beck depression inventory and Hospital Anxiety Depression score to evaluate depression and anxiety

DIAGNOSTIC_TEST

Pancreatic quantitative sensory testing

Pancreatic quantitative sensory testing will be performed to evaluate temporal summation, pain detection threshold, pain tolerance threshold, and conditioned pain modulation.

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    collaborator OTHER
  • SIDS Hospital and Research Center, Surat

    collaborator UNKNOWN
  • Aalborg University Hospital

    collaborator OTHER
  • Asian Institute of Gastroenterology, India

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05713344 on ClinicalTrials.gov