Back to resultsThe Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease
Primary Purpose
Idiopathic Parkinson's Disease, Constipation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
biofeedback therapy
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Biofeedback, constipation, Parkinson's disease
Eligibility Criteria
Inclusion Criteria:
- Idiopathic Parkinson's disease
Exclusion Criteria:
- Secondary Parkinson's disease
Sites / Locations
- Seung-Jae, Myung
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
biofeedback
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the effectiveness of biofeedback therapy in Parkinson's disease
Secondary Outcome Measures
to evaluate the constipation type in Parkinson's disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00869830
Brief Title
The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease
Official Title
The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aims of the investigators' study are to characterize the nature of constipation in idiopathic Parkinson's disease (IPD) and to evaluate the usefulness of biofeedback therapy in constipated IPD patients.
Detailed Description
The medical treatment of idiopathic Parkinson's disease (IPD) alleviates constipation symptoms due to the restoration of autonomic dysfunction. However, additional laxatives are usually needed in these patients. Other suppository treatments included stool softeners, dopamine-receptor agonists, botulinum toxins, and prokinetic medications such as tegaserod. Biofeedback therapy (BFT) has been the gold standard for functional constipation with dyssynergic defecation or rectal hyposensitivity. However, researchers have not tried to evaluate its usefulness in constipated IPD patients up to now. The aims of our study are to characterize the nature of constipation in IPD and to evaluate the usefulness of BFT in constipated IPD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease, Constipation
Keywords
Biofeedback, constipation, Parkinson's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
biofeedback
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
biofeedback therapy
Other Intervention Name(s)
perianal sensor (Perry, Elan, SRS Medical Systems, Redmond, WA, USA), biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA).
Intervention Description
biofeedback therapy was applied using the surface electromyography (EMG) method with a perianal sensor (Perry, Elan, SRS Medical Systems, Redmond, WA, USA) and biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA).
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of biofeedback therapy in Parkinson's disease
Time Frame
usually six sessions per one biofeedback for 3 months
Secondary Outcome Measure Information:
Title
to evaluate the constipation type in Parkinson's disease
Time Frame
3-6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic Parkinson's disease
Exclusion Criteria:
Secondary Parkinson's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kee Wook Jung, M.D.
Organizational Affiliation
Asan Digestive Disease Research Institute, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seung-Jae, Myung
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
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The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease
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