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

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00869830

Collaborator

(none)

Enrollment

Location

Arm

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Parkinson's Disease Constipation	Other: biofeedback therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

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 :

Jan 1, 2007

Actual Primary Completion Date :

Aug 1, 2008

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

To evaluate the effectiveness of biofeedback therapy in Parkinson's disease [usually six sessions per one biofeedback for 3 months]

Secondary Outcome Measures

to evaluate the constipation type in Parkinson's disease [3-6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Idiopathic Parkinson's disease

Exclusion Criteria:

Secondary Parkinson's disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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