Acupuncture for Fatigue in Parkinson's Disease
This study has been completed.
Sponsor:
University of Colorado, Denver
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01360229
First received: May 23, 2011
Last updated: August 10, 2015
Last verified: August 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parkinsons Disease |
Procedure: Acupuncture Other: Acupuncture to treat fatigue in Parkinson disease |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease |
Resource links provided by NLM:
Further study details as provided by University of Colorado, Denver:
Primary Outcome Measures:
- Modified Fatigue Impact Scale (MFIS) between treatment groups [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]The primary outcome measure will be the 6-week change in Modified Fatigue Impact Scale (MFIS) between treatment groups
| Enrollment: | 88 |
| Study Start Date: | August 2010 |
| Study Completion Date: | May 2015 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Sham Comparator: Randomized Subjects receive a sham acupuncture.
Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
|
Other: Acupuncture to treat fatigue in Parkinson disease
Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.
|
|
Active Comparator: Randomized Subjects receive real acupuncture.
Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
|
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
|
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360229
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360229
Locations
| United States, Colorado | |
| University of Colorado Denver | |
| Aurora, Colorado, United States, 80045 | |
Sponsors and Collaborators
University of Colorado, Denver
Michael J. Fox Foundation for Parkinson's Research
Investigators
| Principal Investigator: | Benzi Kluger, MD | University of Colorado, Denver |
More Information
Additional Information:
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01360229 History of Changes |
| Other Study ID Numbers: | 10-0533 |
| Study First Received: | May 23, 2011 |
| Last Updated: | August 10, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
Parkinsons Disease Fatigue |
Additional relevant MeSH terms:
|
Parkinson Disease Fatigue Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on September 27, 2016