Acupuncture for Fatigue in Parkinson's Disease

NCT ID: NCT01360229

Last Updated: 2019-08-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinsons Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Randomized Subjects receive a sham acupuncture.

Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.

Group Type SHAM_COMPARATOR

Acupuncture to treat fatigue in Parkinson disease

Intervention Type OTHER

Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.

Randomized Subjects receive real acupuncture.

Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Acupuncture to treat fatigue in Parkinson disease

Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benzi Kluger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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10-0533

Identifier Type: -

Identifier Source: org_study_id

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