Tan Tock Seng Hospital
Singapore, 308433
NCT Number: NCT02587754
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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Notify Me21 year–85 year
All sexes
Interventional
Not applicable
Singapore, 308433
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 sessions of acupuncture, twice a week over 5 weeks.
Time frame: General Fatigue score of the Multidimensional Fatigue Inventory at week 5
Measure of fatigue
Time frame: General Fatigue score of the Multidimensional Fatigue Inventory at week 9
Measure of fatigue
Time frame: UPDRS score at week 5
Measure of severity of Parkinson's Disease
Time frame: UPDRS score at week 9
Measure of severity of Parkinson's Disease
Time frame: PD 39 score at week 5
Measure of quality of life
Time frame: PD 39 score at week 9
Measure of quality of life
Time frame: GDS score at week 5
Measure of depression
Time frame: GDS score at week 9
Measure of depression
Time frame: Adverse events will be captured up to 9 weeks
all adverse events
Tan Tock Seng Hospital
Other
Acupuncture in the Treatment of Fatigue in Parkinson's Disease: a Pilot Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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