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| Name | Class |
|---|---|
| Ministry of Health, Singapore | OTHER_GOV |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum acupuncture | Active Comparator | 10 sessions of verum acupuncture |
|
| Placebo acupuncture | Placebo Comparator | 10 sessions of placebo acupuncture via use of placebo acupuncture needles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | 10 sessions of acupuncture, twice a week over 5 weeks. |
|
| 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 |
| 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 | Description | Time Frame |
|---|---|---|
| Adverse events | all adverse events | Adverse events will be captured up to 9 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keng H Kong, MBBS | Tan Tock Seng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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2 arm study comparing acupuncture with sham
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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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |