Personalized Education and Pain Response in Chronic Pancreatitis

Sponsor
Asian Institute of Gastroenterology, India
Study ID
NCT04654377
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Personalised education — OTHER
    Patients will be explained about their disease and possible outcomes based on clinical, biochemical and imaging data.

Study Details

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.

Key Dates

First listed
Dec 4, 2020
Start date
Aug 1, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Personalised education
    1. Greetings. 2. Recording of demographic, clinical (disease related), nutritional, laboratory, and treatment related data. 3. Administration of questionnaires. 4. Inquiring patient's perception of their disease. 5. Explaining the patient about their disease in general followed by specific aspects and possible outcomes in the context of their perception, clinical aspects, questionnaire, and imaging data. In addition, the general treatment plan will be explained. 6. Address all queries from the patient and care givers.
  • No Intervention: Standard communication
    1. Greetings. 2. Recording of demographic, clinical (disease related), nutritional, laboratory, imaging and treatment related data. 3. Administration of questionnaires. 4. Explaining the general treatment plan. 5. Address general treatment related queries from the patient and care givers.

Primary Outcome Measure

Change in pain score [ Time Frame: 3 and 6 months ]

Central Contacts

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