Fatigue, Parkinson Disease
Conditions
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: 1. Week 0 (baseline) 2. Week 5 (completion of intervention) 3. Week 9 (4 weeks after completion of intervention
Interventions
DEVICEAcupuncture
10 sessions of acupuncture, twice a week over 5 weeks.
Sponsors
Ministry of Health, Singapore
Tan Tock Seng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
2 arm study comparing acupuncture with sham
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Fatigue score of the Multidimensional Fatigue Inventory | General Fatigue score of the Multidimensional Fatigue Inventory at week 5 | Measure of fatigue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Fatigue score of the Multidimensional Fatigue Inventory | General Fatigue score of the Multidimensional Fatigue Inventory at week 9 | Measure of fatigue |
| Unified Parkinson's Disease Rating Scale (UPDRS) | UPDRS score at week 5 | Measure of severity of Parkinson's Disease |
| Parkinson's Disease Questionnaire-39 (PD 39). | PD 39 score at week 5 | Measure of quality of life |
| Geriatric Depression Scale (GDS) | GDS score at week 5 | Measure of depression |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Adverse events will be captured up to 9 weeks | all adverse events |
Countries
Singapore
Outcome results
None listed