Acupuncture for Fatigue in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinsons Disease
• Interventions: Other: Acupuncture to treat fatigue in Parkinson disease; Procedure: Acupuncture

• Registration Number: NCT01360229
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Primary Completion: 2014-12
• Study Completion: 2015-05
• Results First Submitted: 2017-05-04
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-03
• Last Update Submitted: 2019-07-03
• Results First Posted: 2019-08-12
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized Subjects receive a sham acupuncture.	Acupuncture to treat fatigue in Parkinson disease	Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
Randomized Subjects receive real acupuncture.	Acupuncture	Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.

Primary Outcome Measures

Name	Time	Method
Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups	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.

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States