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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
10 sessions of acupuncture, twice a week over 5 weeks.
Tan Tock Seng Hospital
Singapore, Singapore
General Fatigue score of the Multidimensional Fatigue Inventory
Measure of fatigue
Time frame: General Fatigue score of the Multidimensional Fatigue Inventory at week 5
General Fatigue score of the Multidimensional Fatigue Inventory
Measure of fatigue
Time frame: 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
Time frame: UPDRS score at week 5
Unified Parkinson's Disease Rating Scale (UPDRS)
Measure of severity of Parkinson's Disease
Time frame: UPDRS score at week 9
Parkinson's Disease Questionnaire-39 (PD 39).
Measure of quality of life
Time frame: PD 39 score at week 5
Parkinson's Disease Questionnaire-39 (PD 39).
Measure of quality of life
Time frame: PD 39 score at week 9
Geriatric Depression Scale (GDS)
Measure of depression
Time frame: GDS score at week 5
Geriatric Depression Scale (GDS)
Measure of depression
Time frame: GDS score at week 9
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