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临床试验/NCT04654377
NCT04654377尚未招募不适用

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

Asian Institute of Gastroenterology, India2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
114
试验地点
2
主要终点
Change in pain score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Chronic pancreatitis of at least 3 years
  • •At least 3 episodes of pain in the past 3 months
  • •Age 18-60yrs
  • •Both genders

排除标准

  • •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..

研究组 & 干预措施

Personalised education

Experimental
  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.

干预措施: Personalised education (Other)

Standard communication

No Intervention
  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.

结局指标

主要结局

Change in pain score

时间窗: 3 and 6 months

Pain will be measured using the Visual analog scale (0-10)

Change in pain score

时间窗: 3 and 6 months

Pain will be measured using the Visual analog scale (0-10)

次要结局

  • Change in sleep behaviour(3 and 6 months)
  • Change in the patient's perception of alteration in pain(3 and 6 months)
  • Difference in analgesic requirement(3 and 6 months)
  • Change in depression score(3 and 6 months)
  • Change in multidimensional aspects of pain(3 and 6 months)
  • Change in the number of hospital visits(3 and 6 months)
  • Change in quality of life (QOL)(3 and 6 months)
  • Change in the patient's perception of alteration in pain(3 and 6 months)
  • Difference in analgesic requirement(3 and 6 months)
  • Change in number of painful days(3 and 6 months)
  • Change in anxiety score(3 and 6 months)
  • Change in neuropathic pain(3 and 6 months)
  • Change in the psychological aspects of pain(3 and 6 months)
  • Change in sleep behaviour(3 and 6 months)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rupjyoti Talukdar

Director, Pancreatology; Head, Pancreas Research Group and Division of Gut Microbiome Research

Asian Institute of Gastroenterology, India

研究点 (2)

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