Acupuncture in the Treatment of Fatigue in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Acupuncture in the Treatment of Fatigue in Parkinson's Disease: a Pilot Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587754
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: July 6, 2017
• Start date: November 2015
• Est. completion date: April 27, 2017

Study information

• Verified date: April 2017
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 27, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Parkinson Disease

Intervention

Device:
• Acupuncture
10 sessions of acupuncture, twice a week over 5 weeks.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Ministry of Health, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	all adverse events	Adverse events will be captured up to 9 weeks
Primary	General Fatigue score of the Multidimensional Fatigue Inventory	Measure of fatigue	General Fatigue score of the Multidimensional Fatigue Inventory at week 5
Secondary	General Fatigue score of the Multidimensional Fatigue Inventory	Measure of fatigue	General Fatigue score of the Multidimensional Fatigue Inventory at week 9
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS)	Measure of severity of Parkinson's Disease	UPDRS score at week 5
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS)	Measure of severity of Parkinson's Disease	UPDRS score at week 9
Secondary	Parkinson's Disease Questionnaire-39 (PD 39).	Measure of quality of life	PD 39 score at week 5
Secondary	Parkinson's Disease Questionnaire-39 (PD 39).	Measure of quality of life	PD 39 score at week 9
Secondary	Geriatric Depression Scale (GDS)	Measure of depression	GDS score at week 5
Secondary	Geriatric Depression Scale (GDS)	Measure of depression	GDS score at week 9