Acupuncture in the Treatment of Fatigue in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-04-27

Brief Summary

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This study evaluates the efficacy of acupuncture in the treatment of fatigue in participants with Parkinson's Disease. Half of participants will receive real acupuncture while the half will receive placebo acupuncture.

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Detailed Description

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This will be a single centre, single blinded 2-group randomized controlled study, with participants receiving either verum acupuncture or placebo acupuncture.

A retractable non-invasive placebo needle will be used in the placebo arm. Both the real and placebo needles have a fine needle body and copy handle and look exactly the same. However, the placebo needle has a retractable shaft and blunt tip. When pressed onto the skin, it telescopes into the handle and the blunt tip stays on the skin instead of penetrating it. The plastic tube with adhesive foot-plate is placed on the skin to hold it in place. The real needle, on the other hand, has a normal sharp tip which allows it to pierce the skin.

The following acupoints will be needled: Stomach 36 (bilateral), Spleen 6 (bilateral), Kidney 3 (bilateral), Large Intestine 4 (bilateral), Pericardium 6 (bilateral), and Conception Vessel 6. These points were chosen based on Traditional Chinese Medicine theory (which attributed fatigue to deficiencies of spleen, kidney and qi).

Each acupuncture session will be based on a strict protocol, and conversation between acupuncturists and participants will be kept to a minimum.

Participants will be assessed at 3 intervals:

1. Week 0 (baseline)
2. Week 5 (completion of intervention)
3. Week 9 (4 weeks after completion of intervention

Conditions

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Parkinson Disease Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 arm study comparing acupuncture with sham

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Verum acupuncture

10 sessions of verum acupuncture

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

10 sessions of acupuncture, twice a week over 5 weeks.

Placebo acupuncture

10 sessions of placebo acupuncture via use of placebo acupuncture needles

Group Type PLACEBO_COMPARATOR

Acupuncture

Intervention Type DEVICE

10 sessions of acupuncture, twice a week over 5 weeks.

Interventions

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Acupuncture

10 sessions of acupuncture, twice a week over 5 weeks.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of PD based on criteria developed by Gelb et al which is adopted by the National Institute of Neurological Disorders and Stroke, US National Institute of Health.
2. Age 21-85 years old
3. Presence of persistent fatigue of a moderate level for at least 4 weeks' duration. Moderate fatigue is defined as a score of ≥10 on the general fatigue domain of the Multidimensional Fatigue Inventory.
4. No acupuncture treatment in the past 6 months.

Exclusion Criteria

1. Significant cognitive, language or psychiatric illnesses which prevents the subject from understanding instructions and participating in the study.
2. Needle phobia
3. Comorbidity with a bleeding disorder
4. Known anemia with hemoglobin level less than 10g/dl.
5. Known congestive cardiac failure and/or end stage renal disease
6. Female subjects of childbearing age
7. Presence of symptomatic postural hypotension

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No