Personalized Education and Pain Response in Chronic Pancreatitis
Not yet recruitingNot applicableNCT04654377
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Pain mechanisms in chronic pancreatitis (CP) are heterogeneous and includes nociception, pancreatic neuropathy and central neuropathy/neuroplasty. These mechanisms could occur simultaneously in variable proportions and could explain why several patients develop recurrence of pain even after being treated by all the currently available modalities, such as antioxidants, endoscopic therapies and surgery. In the studies by the investigators over the past 2 years, they observed that persistent pain in these patients was associated with varying grades of depression and poor quality of life. This was accompanied by alteration in the metabolites in the brain (anterior cingulate cortex, prefrontal cortex, hippocampus, and basal ganglia) as evidenced in magnetic resonance spectroscopy (MRS) of the brain. These areas in the brain are responsible for pain modulation, long-term pain memory and emotional responses to pain. When the investigators counselled these patients and explained their disease and possible outcomes based on their own clinical course, imaging and treatment response (personalized education/counselling), they reported significant improvement in depression, quality of life parameters and, interestingly, also in pain. Further, there were changes in the metabolite parameters in the brain on MRS after personalized counselling/education that was more similar to that of healthy controls. This led to our hypothesis that better understanding of the disease and its outcomes by the patients could improve their coping capabilities and increase their pain thresholds. This could augment the pain responses of these patients to the other therapeutic modalities. We will conduct this single blinded, placebo controlled, randomized controlled trial on patients with documented CP of over 3 years duration, who had at least 3 episodes of abdominal pain of over the past 3 months.
Study details
- Official title
- Impact of Personalized Education on Pain Response in Patients With Chronic Pancreatitis (PEPCP)
- Conditions
- Chronic Pancreatitis
- Pain Syndrome
- Depression, Anxiety
- Interventions
- Other: Personalised education
- Sponsor
- Asian Institute of Gastroenterology, India
- Start date
- 2025-08-01
- Primary completion
- 2026-07-31
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- India
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Chronic pancreatitis of at least 3 years * At least 3 episodes of pain in the past 3 months * Age 18-60yrs * Both genders Exclusion Criteria: * Acute pancreatitis episode at the time of enrolment. * Pancreatic cancer. * Other chronic diseases (including end organ damage related to diabetes). * Adverse life event in the family in the past 6 months. * Active substance use (alcohol, smoking, smokeless tobacco, Illicit drugs). * Pregnancy and lactation. * Psychiatric illness at enrolment or during follow-up, and/or concomitant intake of antidepressants and neuromodulators..
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04654377