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Sponsored by: |
Asan Medical Center |
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Information provided by: | Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT00869830 |
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.
Condition | Intervention |
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Idiopathic Parkinson's Disease Constipation |
Other: biofeedback therapy |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease |
Enrollment: | 30 |
Study Start Date: | January 2007 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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biofeedback: Experimental |
Other: biofeedback therapy
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).
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Seung-Jae, Myung | |
Seoul, Korea, Republic of, 138-736 |
Principal Investigator: | Kee Wook Jung, M.D. | Asan Digestive Disease Research Institute, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea |
Responsible Party: | Asan Digestive Disease Research Institute, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea ( Seung-Jae, Myung, Assistant Professor ) |
Study ID Numbers: | BFT in IPD |
Study First Received: | March 25, 2009 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00869830 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Biofeedback constipation Parkinson's disease |
Signs and Symptoms Ganglion Cysts Signs and Symptoms, Digestive Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Constipation Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Signs and Symptoms Signs and Symptoms, Digestive Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Constipation Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |