Clinical trial NCT02587754: Acupuncture in the Treatment of Fatigue in Parkinson's Disease
Official title: Acupuncture in the Treatment of Fatigue in Parkinson's Disease: a Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Fatigue
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
First posted: 2015-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm study comparing acupuncture with sham
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: General Fatigue score of the Multidimensional Fatigue Inventory
timeFrame: General Fatigue score of the Multidimensional Fatigue Inventory at week 5
Secondary outcomes:
measure: General Fatigue score of the Multidimensional Fatigue Inventory
timeFrame: General Fatigue score of the Multidimensional Fatigue Inventory at week 9
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: UPDRS score at week 5
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: UPDRS score at week 9
measure: Parkinson's Disease Questionnaire-39 (PD 39).
timeFrame: PD 39 score at week 5
measure: Parkinson's Disease Questionnaire-39 (PD 39).
timeFrame: PD 39 score at week 9
measure: Geriatric Depression Scale (GDS)
timeFrame: GDS score at week 5
measure: Geriatric Depression Scale (GDS)
timeFrame: GDS score at week 9
Other outcomes:
measure: Adverse events
timeFrame: Adverse events will be captured up to 9 weeks
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Keng H Kong, MBBS
role: PRINCIPAL_INVESTIGATOR
References: