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

University of Colorado, Denver1 site in 1 country94 target enrollmentAugust 2010

ConditionsParkinsons Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinsons Disease
Sponsor: University of Colorado, Denver
Enrollment: 94
Locations: 1
Primary Endpoint: Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

May 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Colorado, Denver

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups

Time Frame: 6 weeks

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.