Acupuncture for Fatigue in Parkinson's Disease
Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 23, 2011
CompletedFirst Posted
Study publicly available on registry
May 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
August 12, 2019
CompletedAugust 12, 2019
July 1, 2019
4.3 years
May 23, 2011
May 4, 2017
July 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Randomized Subjects receive a sham acupuncture.
SHAM COMPARATORSubjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
Randomized Subjects receive real acupuncture.
ACTIVE COMPARATORSubjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
Interventions
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
Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Denver
Aurora, Colorado, 80045, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Benzi Kluger
- Organization
- University of Colorado School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Benzi Kluger, MD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2011
First Posted
May 25, 2011
Study Start
August 1, 2010
Primary Completion
December 1, 2014
Study Completion
May 1, 2015
Last Updated
August 12, 2019
Results First Posted
August 12, 2019
Record last verified: 2019-07