Acupuncture in the Treatment of Fatigue in Parkinson's Disease

Acupuncture in the Treatment of Fatigue in Parkinson's Disease: a Pilot Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Parkinson Disease
• Intervention / Treatment: Device: Acupuncture

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Verum acupuncture; 10 sessions of verum acupuncture	Device: Acupuncture; 10 sessions of acupuncture, twice a week over 5 weeks.
PLACEBO_COMPARATOR: Placebo acupuncture; 10 sessions of placebo acupuncture via use of placebo acupuncture needles	Device: Acupuncture; 10 sessions of acupuncture, twice a week over 5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Fatigue score of the Multidimensional Fatigue Inventory	Measure of fatigue	General Fatigue score of the Multidimensional Fatigue Inventory at week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Fatigue score of the Multidimensional Fatigue Inventory	Measure of fatigue	General Fatigue score of the Multidimensional Fatigue Inventory at week 9
Unified Parkinson's Disease Rating Scale (UPDRS)	Measure of severity of Parkinson's Disease	UPDRS score at week 5
Unified Parkinson's Disease Rating Scale (UPDRS)	Measure of severity of Parkinson's Disease	UPDRS score at week 9
Parkinson's Disease Questionnaire-39 (PD 39).	Measure of quality of life	PD 39 score at week 5
Parkinson's Disease Questionnaire-39 (PD 39).	Measure of quality of life	PD 39 score at week 9
Geriatric Depression Scale (GDS)	Measure of depression	GDS score at week 5
Geriatric Depression Scale (GDS)	Measure of depression	GDS score at week 9

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	all adverse events	Adverse events will be captured up to 9 weeks

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Collaborators: Ministry of Health, Singapore
• Investigators: Principal Investigator: Keng H Kong, MBBS, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): April 27, 2017

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: October 25, 2015
• First Posted (ESTIMATE): October 27, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Fatigue; Parkinson Disease
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)