CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
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|ClinicalTrials.gov Identifier: NCT02054910|
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : February 28, 2017
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pancreatitis||Procedure: Celiac Plexus Block Procedure: Sham||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Single Blinded Control Trial Comparing EUS Guided Celiac Plexus Block (CPB) Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Celiac Plexus Block
Celiac Plexus Block will be administered following EUS
Procedure: Celiac Plexus Block
Patients will receive celiac plexus block during endoscopy.
Sham Comparator: Sham
A celiac plexus block will not be administered for pain management
Patients will not receive celiac plexus block during endoscopy.
- Change in Pain Response Over a 6 Month Period of Time Using the VAS Score [ Time Frame: baseline to 6 months ]Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain.
- Mean Quality of Life Score Between Each Group at 6 Months [ Time Frame: 6 months post baseline ]The American Chronic Pain Association, Quality of Life Score will be used. This scoring ranges from 0 (Stay in bed all day Feel hopeless and helpless about life - non-functioning) to 10 (Go to work/volunteer each day Normal daily activities each day Have a social life outside of work Take an active part in family life - normal life).
- Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline [ Time Frame: baseline to 6 months ]the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.
- Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months. [ Time Frame: baseline to 6 months ]
The Beck's Depression scale was used to indicate subject's depression:
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
- Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure [ Time Frame: baseline to 6 months ]The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group
- % of Subjects in Each Group That Are Employed at 6 Months Post Procedure. [ Time Frame: baseline to 6 months ]Subjects will be asked about employment at 6 months post procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054910
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Charles M Wilcox, MD||University of Alabama at Birmingham|