- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01360229
Acupuncture for Fatigue in Parkinson's Disease
July 3, 2019 updated by: University of Colorado, Denver
Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Denver
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Randomized Subjects receive a sham acupuncture.
Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
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Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.
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Active Comparator: Randomized Subjects receive real acupuncture.
Subjects will be randomized in a 1:1 ratio to receive either real or sham 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Benzi Kluger, MD, University of Colorado, Denver
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
May 23, 2011
First Submitted That Met QC Criteria
May 24, 2011
First Posted (Estimate)
May 25, 2011
Study Record Updates
Last Update Posted (Actual)
August 12, 2019
Last Update Submitted That Met QC Criteria
July 3, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-0533
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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