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Acupuncture for Fatigue in Parkinson's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01360229
First Posted: May 25, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
University of Colorado, Denver
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 23, 2011
First Posted: May 25, 2011
Last Update Posted: October 12, 2017
Last Verified: August 2015

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