Acupuncture for Fatigue in Parkinson's Disease

Parkinsons Disease Clinical Trial

Official title:

Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360229
• Other study ID #: 10-0533
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: May 2015

Study information

• Verified date: July 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will receive either real or sham acupuncture twice weekly for six weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients with PD

• Patients 40-99 years of age

• Patients who have significant fatigue

• Patients must be on a stable medication regimen for the treatment of PD

Exclusion Criteria:

• Patients who have had previous acupuncture within the past six months

• Patients who have had deep brain stimulation (DBS)

• Patients with dementia, depression, or sleep disorder

• Patients who are currently taking medications known to affect fatigue, such as stimulants

Related Conditions & MeSH terms

• Fatigue
• Parkinson Disease
• Parkinsons Disease

Intervention

Procedure:
• Acupuncture
Subjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes

Other:
• Acupuncture to treat fatigue in Parkinson disease
Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups	The primary outcome measure will be the change between the baseline visit and 6-week time point in the Modified Fatigue Impact Scale Total (MFIS) between treatment groups. The range of the score is 0-84 with higher scores reflecting more severe fatigue.	6 weeks

External Links

•   Link