Pain Phenotypes in Chronic Pancreatitis

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Pain Phenotypes in Chronic Pancreatitis and Identification of Clinical Surrogates of Pancreatic Neuropathy

Conditions
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Chronic Pancreatitis

Intervention / Treatment
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* Other: Clinical history
* Other: Clinical examination
* Other: Evaluation of quality of life
* Other: Evaluation of mental state
* Diagnostic Test: Pancreatic quantitative sensory testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 3 years of disease (chronic pancreatitis) Both genders Able to provide informed consent Exclusion Criteria: Acute exacerbation of chronic pancreatitis Moderate to severe abdominal pain at the time of screening Pancreatic cancer or other malignancies Use of antidepressants, narcotics, and neuromodulators

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of pain | The type of pancreatic pain, i.e nociceptive or neuropathic will be determined | 18 months | 
| Quality of life | EORTC QLQ c30 score | 18 months | 
| Mental status | Depression and anxiety will be determined | 18 months | 
| Neural sensitization | Presence of localised and widespread sensitisation will be determined. | 18 months |