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NCT00869830 Clinical Trial

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

Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00869830
Other study ID # BFT in IPD
Secondary ID
Status Completed
Phase N/A
First received March 25, 2009
Last updated March 25, 2009
Start date January 2007

Study information
Verified date March 2009
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Idiopathic Parkinson's disease

Exclusion Criteria:

- Secondary Parkinson's disease

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
Korea, Republic of Seung-Jae, Myung Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the effectiveness of biofeedback therapy in Parkinson's disease usually six sessions per one biofeedback for 3 months No
Secondary to evaluate the constipation type in Parkinson's disease 3-6 months No
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