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The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00869830
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : March 26, 2009
Sponsor:
Information provided by:
Asan Medical Center

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.

Condition or disease Intervention/treatment
Idiopathic Parkinson's Disease Constipation Other: biofeedback therapy

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease
Study Start Date : January 2007
Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: biofeedback 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).
Other Names:
  • perianal sensor (Perry, Elan, SRS Medical Systems, Redmond, WA, USA)
  • biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA).



Primary Outcome Measures :
  1. To evaluate the effectiveness of biofeedback therapy in Parkinson's disease [ Time Frame: usually six sessions per one biofeedback for 3 months ]

Secondary Outcome Measures :
  1. to evaluate the constipation type in Parkinson's disease [ Time Frame: 3-6 months ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's disease

Exclusion Criteria:

  • Secondary Parkinson's disease

Information from the National Library of Medicine

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): NCT00869830


Locations
Korea, Republic of
Seung-Jae, Myung
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
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: Seung-Jae, Myung, Assistant Professor, Asan Digestive Disease Research Institute, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT00869830     History of Changes
Other Study ID Numbers: BFT in IPD
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: March 26, 2009
Last Verified: March 2009

Keywords provided by Asan Medical Center:
Biofeedback
constipation
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Constipation
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms, Digestive
Signs and Symptoms