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Personalized Education and Pain Response in Chronic Pancreatitis

Impact of Personalized Education on Pain Response in Patients With Chronic Pancreatitis (PEPCP)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04654377
Acronym
PEPCP
Enrollment
114
Registered
2020-12-04
Start date
2025-08-01
Completion date
2026-12-31
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis, Depression, Anxiety, Pain Syndrome

Keywords

chronic pancreatitis, pain, depression, anxiety, quality of life, metabolome, magnetic resonance spectroscopy, quantitative sensory testing

Brief summary

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.

Detailed description

Chronic pancreatitis (CP) is characterised by pain, exocrine insufficiency and endocrine dysfunction. Of all symptoms, intractable abdominal pain is the most debilitating that mandates a multidisciplinary treatment approach. Long term treatment of pain begins with antioxidants. If the pancreatic duct contains stones in a limited area (head, neck and proximal body), the patient is subjected to endoscopic treatment, which includes extracorporeal shock wave lithotripsy (ESWL) for large stones (\>5mm) with or without pancreatic duct stenting. For smaller stones, endoscopic retrograde cholangiopancreatography (ERCP) alone suffices. ERCP with pancreatic ductal stenting is also the first line treatment for a solitary symptomatic pancreatic ductal stricture. If symptomatic stones are located all along the pancreatic duct, or if there are multiple strictures, surgical drainage of the pancreatic duct becomes the treatment of choice. If there are any mass lesion in the pancreas on the background of CP, then resection procedures such as Whipple's operation or distal pancreatectomy with/without splenectomy is resorted to. Even though the above mentioned modalities are directed to relief the patient of pain, a substantial proportion of patients return with recurrence of pain. This explains the complexity in the pain mechanisms in CP. Pain mechanisms in chronic pancreatitis (CP) are heterogeneous and includes nociception, pancreatic neuropathy and central neuropathy/neuroplasticity. 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. Since CP is a chronic disease with systemic effects, several additional factors could impact the evolution and response to pain. These could include the patient's personality traits, educational background, family history of CP, previous experience of the disease, background knowledge of CP, coping capability, to name a few. The investigators have been working on these aspects for the past couple of years, wherein they looked into the mental status (depression/anxiety), quality of life and the impact of pain in these aspects. Since pain memory and emotional responses to pain is mediated by the basal ganglia, hippocampus, anterior cingulate cortex and prefrontal cortex of the brain, the investigators also looked at the metabolites in these areas using magnetic resonance spectroscopy. The investigators observed that persistent pain in these patients will be associated with varying grades of depression and poor quality of life. This was accompanied by alteration in the metabolites myoinositol, creatine, glycine/glutamate in the hippocampus, and basal ganglia Following this, 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 were more closer to that of healthy controls. This led to the 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. The investigators 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. The investigators will provide detailed education regarding the disease to the patients (based on their disease characteristics) in the study arm and evaluate the changes in pain scores, pain episodes, QOL, mental status and metabolomic status in the brain (hippocampus, basal ganglia, anterior cingulate cortex, prefrontal cortex).

Interventions

OTHERPersonalised education

Patients will be explained about their disease and possible outcomes based on clinical, biochemical and imaging data.

Sponsors

Asian Institute of Gastroenterology, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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..

Design outcomes

Primary

MeasureTime frameDescription
Change in pain score3 and 6 monthsPain will be measured using the Visual analog scale (0-10)

Secondary

MeasureTime frameDescription
Change in number of painful days3 and 6 monthsThe patient will record the number of painful days in a self reported pain questionnaire.
Change in the number of hospital visits3 and 6 monthsThe patient will record the number of hospital visits in a self reported daily questionnaire.
Change in neuropathic pain3 and 6 monthsNeuropathic pain will be evaluated using the PainDetect tool
Change in quality of life (QOL)3 and 6 monthsQuality of life (QOL) will be measured using the EORTC QLQ 30
Change in depression score3 and 6 monthsDepression will be measured using Beck depression Inventory (BDI) II
Change in multidimensional aspects of pain3 and 6 monthsMultidimensional aspects of pain will be measured using the COMPAT-SF
Change in the psychological aspects of pain3 and 6 monthsPsychological aspects of pain will be measured using the Pain Catastrophising score (PCS)
Change in sleep behaviour3 and 6 monthsChange in sleep behaviour will be measured using the Pittsburg Sleep Quality Index
Change in the patient's perception of alteration in pain3 and 6 monthsPatient's perception of alteration in pain will be measured using the Patient's Global Impression of Pain (PGIC)
Difference in analgesic requirement3 and 6 monthsDifference in analgesic requirement will be measured by number of opioids and NSAIDs requirement
Change in anxiety score3 and 6 monthsAnxiety will be measured using the Hospital anxiety and depression (HADS) tools.

Other

MeasureTime frameDescription
Evaluation of possible mechanisms of improvement.3 and 6 monthsPossible mechanisms of improvement improvement will be assessed by measuring the plasma metabolites serotonin, dopamine, oxytocin, GABA, tryptophan and endorphins.

Countries

India

Contacts

Primary ContactRupjyoti Talukdar, MD, FICP, AGAF
rup_talukdar@yahoo.com7032804231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026