Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04654377
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2020-11-27
Brief Title:
Personalized Education and Pain Response in Chronic Pancreatitis
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology India
Study Overview
Official Title:
Impact of Personalized Education on Pain Response in Patients With Chronic Pancreatitis PEPCP
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEPCP
Brief Summary:
Pain mechanisms in chronic pancreatitis CP are heterogeneous and includes nociception pancreatic neuropathy and central neuropathyneuroplasty 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 educationcounselling 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 counsellingeducation 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 5 episodes of abdominal pain of over the past 6 months
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 educationcounselling 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 counsellingeducation 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 5 episodes of abdominal pain of over the past 6 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 approaches 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 Whipples operation or distal pancreatectomy withwithout 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 neuropathyneuroplasticity 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
One aspect that is often overlooked in studies involving pain mechanisms and management Since CP is a chronic disease with systemic effects several additional factors could impact the evolution and response to pain These could include the patients 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 depressionanxiety 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 glycineglutamate 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 educationcounselling 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 counsellingeducation 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 5 episodes of abdominal pain of over the past 6 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
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 neuropathyneuroplasticity 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
One aspect that is often overlooked in studies involving pain mechanisms and management Since CP is a chronic disease with systemic effects several additional factors could impact the evolution and response to pain These could include the patients 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 depressionanxiety 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 glycineglutamate 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 educationcounselling 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 counsellingeducation 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 5 episodes of abdominal pain of over the past 6 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None