About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chronic pancreatitis of at least 3 years
At least 3 episodes of pain in the past 3 months
Age 18-60yrs
Both genders
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Personalised education
Other interventionPatients will be explained about their disease and possible outcomes based on clinical, biochemical and imaging data.
Treatment groups
Trial outcomes
Primary outcomes
Change in pain score
Pain will be measured using the Visual analog scale (0-10)
Secondary outcomes
Change in number of painful days
The patient will record the number of painful days in a self reported pain questionnaire.
Change in the number of hospital visits
The patient will record the number of hospital visits in a self reported daily questionnaire.
Change in neuropathic pain
Neuropathic pain will be evaluated using the PainDetect tool
Change in quality of life (QOL)
Quality of life (QOL) will be measured using the EORTC QLQ 30
Other outcomes
Evaluation of possible mechanisms of improvement.
Possible mechanisms of improvement improvement will be assessed by measuring the plasma metabolites serotonin, dopamine, oxytocin, GABA, tryptophan and endorphins.
Sponsors and contacts
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