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临床试验/CTRI/2024/11/076237
CTRI/2024/11/076237招募中不适用

Evaluation of pain patterns in idiopathic chronic pancreatitis patients in the background of central sensitization

SIDS Hospital and Research Center1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年11月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
114
试验地点
1
主要终点
To evaluate relation of pain patterns (using COMPAT-SF questionnaire) in chronic pancreatitis with central pain sensitization using P-QST method

研究概览

简要总结

Pain in chronic pancreatitis (CP) is most common and difficult aspects to manage. About 90% of patients with CP suffer from abdominal pain which remains primary cause of hospitalization. Pain in CP results from complex interplay of morphological (increased parenchymal pressure, pancreatic duct hypertension, pancreatic complications) and neural mechanisms (peripheral and central sensitization). Neuroplasticity is an emerging theory to understand mechanism of pain in CP characterized by peripheral and central pain sensitization, and brain reorganization. It manifests clinically as allodynia and hyperalgesia and perceived as one of the driving reasons of pain in CP. Currently available conventional medical and surgical treatments majorly target morphological aspect of pain mechanism which leads to inadequate pain management. Further research in neuroplasticity and identifying brain regions involved pain sensitization can help in understanding and managing pain in CP in a comprehensive fashion. In this study, we will investigate association between clinical pain patterns with central sensitization and brain reorganization using Pancreatic-Quantitative Sensory Testing (P-QST), functional MRI (fMRI), EEG and serum biomarkers.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients age within 18 – 65 years.
  • Patients with confirmed diagnosis of definite idiopathic chronic pancreatitis according to the M-ANNHEIM criteria with or without abdominal pain.
  • Patients with moderate or marked ductal lesions based on Cambridge classification using Computerized Tomography (CT) scan or Endoscopic Retrograde Cholangiopancreatography (ERCP).

排除标准

  • Patients suffering from acute pancreatitis at the time of enrolment.
  • Patients suffering from other painful conditions which render them unable to differentiate between pain of chronic pancreatitis and other painful conditions.
  • Patients who are pregnant at the time of enrolment.
  • Patients with the history of alcohol abuse, current alcohol use, illicit substance use, tobacco use, or current smoker.
  • Patients who received surgical intervention for chronic pancreatitis.
  • Pseudocyst size more than 5 cm.
  • Narcotic drug dependence.

结局指标

主要结局

To evaluate relation of pain patterns (using COMPAT-SF questionnaire) in chronic pancreatitis with central pain sensitization using P-QST method

时间窗: Outcome will be measured at the baseline

次要结局

  • To evaluate relation of pain patterns with EEG changes to evaluate central pain sensitization.(Outcome will be measured at the baseline)
  • To evaluate relation of pain patterns with inflammatory biomarkers(Outcome will be measured at the baseline)

研究者

发起方
SIDS Hospital and Research Center
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Rajiv Mehta

SIDS hospital and research centre

研究点 (1)

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