The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease|
- To evaluate the effectiveness of biofeedback therapy in Parkinson's disease [ Time Frame: usually six sessions per one biofeedback for 3 months ] [ Designated as safety issue: No ]
- to evaluate the constipation type in Parkinson's disease [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869830
|Korea, Republic of|
|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|