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Completed

NCT Number: NCT02587754

Acupuncture in the Treatment of Fatigue in Parkinson's Disease

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.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital

Singapore, 308433

About this study

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:

  • Week 0 (baseline)
  • Week 5 (completion of intervention)
  • Week 9 (4 weeks after completion of intervention

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

10 sessions of acupuncture, twice a week over 5 weeks.

Primary outcomes

  1. 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

  1. General Fatigue score of the Multidimensional Fatigue Inventory

    Time frame: General Fatigue score of the Multidimensional Fatigue Inventory at week 9

    Measure of fatigue

  2. Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: UPDRS score at week 5

    Measure of severity of Parkinson's Disease

  3. Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: UPDRS score at week 9

    Measure of severity of Parkinson's Disease

  4. Parkinson's Disease Questionnaire-39 (PD 39).

    Time frame: PD 39 score at week 5

    Measure of quality of life

  5. Parkinson's Disease Questionnaire-39 (PD 39).

    Time frame: PD 39 score at week 9

    Measure of quality of life

  6. Geriatric Depression Scale (GDS)

    Time frame: GDS score at week 5

    Measure of depression

  7. Geriatric Depression Scale (GDS)

    Time frame: GDS score at week 9

    Measure of depression

Other outcomes

  1. Adverse events

    Time frame: Adverse events will be captured up to 9 weeks

    all adverse events

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • Ministry of Health, Singapore

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2015
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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