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

Overview

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.

Full Title of Study: “The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2008

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.

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: biofeedback

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate the effectiveness of biofeedback therapy in Parkinson’s disease
    • Time Frame: usually six sessions per one biofeedback for 3 months

Secondary Measures

  • to evaluate the constipation type in Parkinson’s disease
    • Time Frame: 3-6 months

Participating in This Clinical Trial

Inclusion Criteria

  • Idiopathic Parkinson's disease Exclusion Criteria:

  • Secondary Parkinson's disease

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asan Medical Center
  • Provider of Information About this Clinical Study
    • 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
  • Overall Official(s)
    • Kee Wook Jung, M.D., Principal Investigator, Asan Digestive Disease Research Institute, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea

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