Acupuncture in the Treatment of Fatigue in Parkinson's Disease: a Pilot Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- General Fatigue score of the Multidimensional Fatigue Inventory
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
General Fatigue score of the Multidimensional Fatigue Inventory
Time Frame: General Fatigue score of the Multidimensional Fatigue Inventory at week 5
Measure of fatigue
Secondary Outcomes
- Geriatric Depression Scale (GDS)(GDS score at week 9)
- General Fatigue score of the Multidimensional Fatigue Inventory(General Fatigue score of the Multidimensional Fatigue Inventory at week 9)
- Unified Parkinson's Disease Rating Scale (UPDRS)(UPDRS score at week 9)
- Parkinson's Disease Questionnaire-39 (PD 39).(PD 39 score at week 9)