Acupuncture in the Treatment of Fatigue in Parkinson's Disease
Primary Purpose
Parkinson Disease, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
- Age 21-85 years old
- 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.
- No acupuncture treatment in the past 6 months.
Exclusion Criteria:
- Significant cognitive, language or psychiatric illnesses which prevents the subject from understanding instructions and participating in the study.
- Needle phobia
- Comorbidity with a bleeding disorder
- Known anemia with hemoglobin level less than 10g/dl.
- Known congestive cardiac failure and/or end stage renal disease
- Female subjects of childbearing age
- Presence of symptomatic postural hypotension
Sites / Locations
- Tan Tock Seng Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Verum acupuncture
Placebo acupuncture
Arm Description
10 sessions of verum acupuncture
10 sessions of placebo acupuncture via use of placebo acupuncture needles
Outcomes
Primary Outcome Measures
General Fatigue score of the Multidimensional Fatigue Inventory
Measure of fatigue
Secondary Outcome Measures
General Fatigue score of the Multidimensional Fatigue Inventory
Measure of fatigue
Unified Parkinson's Disease Rating Scale (UPDRS)
Measure of severity of Parkinson's Disease
Unified Parkinson's Disease Rating Scale (UPDRS)
Measure of severity of Parkinson's Disease
Parkinson's Disease Questionnaire-39 (PD 39).
Measure of quality of life
Parkinson's Disease Questionnaire-39 (PD 39).
Measure of quality of life
Geriatric Depression Scale (GDS)
Measure of depression
Geriatric Depression Scale (GDS)
Measure of depression
Full Information
NCT ID
NCT02587754
First Posted
October 16, 2015
Last Updated
July 6, 2017
Sponsor
Tan Tock Seng Hospital
Collaborators
Ministry of Health, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02587754
Brief Title
Acupuncture in the Treatment of Fatigue in Parkinson's Disease
Official Title
Acupuncture in the Treatment of Fatigue in Parkinson's Disease: a Pilot Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tan Tock Seng Hospital
Collaborators
Ministry of Health, Singapore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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:
Week 0 (baseline)
Week 5 (completion of intervention)
Week 9 (4 weeks after completion of intervention
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 arm study comparing acupuncture with sham
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Verum acupuncture
Arm Type
Active Comparator
Arm Description
10 sessions of verum acupuncture
Arm Title
Placebo acupuncture
Arm Type
Placebo Comparator
Arm Description
10 sessions of placebo acupuncture via use of placebo acupuncture needles
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
10 sessions of acupuncture, twice a week over 5 weeks.
Primary Outcome Measure Information:
Title
General Fatigue score of the Multidimensional Fatigue Inventory
Description
Measure of fatigue
Time Frame
General Fatigue score of the Multidimensional Fatigue Inventory at week 5
Secondary Outcome Measure Information:
Title
General Fatigue score of the Multidimensional Fatigue Inventory
Description
Measure of fatigue
Time Frame
General Fatigue score of the Multidimensional Fatigue Inventory at week 9
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Description
Measure of severity of Parkinson's Disease
Time Frame
UPDRS score at week 5
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Description
Measure of severity of Parkinson's Disease
Time Frame
UPDRS score at week 9
Title
Parkinson's Disease Questionnaire-39 (PD 39).
Description
Measure of quality of life
Time Frame
PD 39 score at week 5
Title
Parkinson's Disease Questionnaire-39 (PD 39).
Description
Measure of quality of life
Time Frame
PD 39 score at week 9
Title
Geriatric Depression Scale (GDS)
Description
Measure of depression
Time Frame
GDS score at week 5
Title
Geriatric Depression Scale (GDS)
Description
Measure of depression
Time Frame
GDS score at week 9
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
all adverse events
Time Frame
Adverse events will be captured up to 9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Age 21-85 years old
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.
No acupuncture treatment in the past 6 months.
Exclusion Criteria:
Significant cognitive, language or psychiatric illnesses which prevents the subject from understanding instructions and participating in the study.
Needle phobia
Comorbidity with a bleeding disorder
Known anemia with hemoglobin level less than 10g/dl.
Known congestive cardiac failure and/or end stage renal disease
Female subjects of childbearing age
Presence of symptomatic postural hypotension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keng H Kong, MBBS
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
Acupuncture in the Treatment of Fatigue in Parkinson's Disease
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