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

This study has been completed.
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00869830
First received: March 25, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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
Idiopathic Parkinson's Disease
Constipation
Other: biofeedback therapy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • to evaluate the constipation type in Parkinson's disease [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2007
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's disease

Exclusion Criteria:

  • Secondary Parkinson's disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 25, 2009
Last Updated: March 25, 2009
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014