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Acupuncture for Fatigue in Parkinson's Disease

Primary Purpose

Parkinsons Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Acupuncture to treat fatigue in Parkinson disease
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinsons Disease focused on measuring Parkinsons Disease, Fatigue

Eligibility Criteria

40 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Randomized Subjects receive a sham acupuncture.

Randomized Subjects receive real acupuncture.

Arm Description

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 either real or sham acupuncture.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2011
Last Updated
July 3, 2019
Sponsor
University of Colorado, Denver
Collaborators
Michael J. Fox Foundation for Parkinson's Research
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1. Study Identification

Unique Protocol Identification Number
NCT01360229
Brief Title
Acupuncture for Fatigue in Parkinson's Disease
Official Title
Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Michael J. Fox Foundation for Parkinson's Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsons Disease
Keywords
Parkinsons Disease, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized Subjects receive a sham acupuncture.
Arm Type
Sham Comparator
Arm Description
Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
Arm Title
Randomized Subjects receive real acupuncture.
Arm Type
Active Comparator
Arm Description
Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Acupuncture to treat fatigue in Parkinson disease
Intervention Description
Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.
Primary Outcome Measure Information:
Title
Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benzi Kluger, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.michaeljfox.org/
Description
Related Info

Learn more about this trial

Acupuncture for Fatigue in Parkinson's Disease

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