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Acupuncture for Fatigue in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01360229
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : August 11, 2015
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Parkinsons Disease Procedure: Acupuncture Other: Acupuncture to treat fatigue in Parkinson disease Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : May 2015

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01360229     History of Changes
Other Study ID Numbers: 10-0533
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: August 11, 2015
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