Acupuncture in the Treatment of Fatigue in Parkinson's Disease

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

Sponsoren

Hauptsponsor: Tan Tock Seng Hospital

Mitarbeiter: Ministry of Health, Singapore

Quelle Tan Tock Seng Hospital
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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

Gesamtstatus Completed
Anfangsdatum November 2015
Fertigstellungstermin April 27, 2017
Primäres Abschlussdatum March 2017
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
General Fatigue score of the Multidimensional Fatigue Inventory General Fatigue score of the Multidimensional Fatigue Inventory at week 5
Sekundäres Ergebnis
Messen Zeitfenster
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 5
Unified Parkinson's Disease Rating Scale (UPDRS) UPDRS score at week 9
Parkinson's Disease Questionnaire-39 (PD 39). PD 39 score at week 5
Parkinson's Disease Questionnaire-39 (PD 39). PD 39 score at week 9
Geriatric Depression Scale (GDS) GDS score at week 5
Geriatric Depression Scale (GDS) GDS score at week 9
Einschreibung 40
Bedingung
Intervention

Interventionsart: Device

Interventionsname: Acupuncture

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

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 21 Years

Maximales Alter: 85 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Keng H Kong, MBBS Principal Investigator Tan Tock Seng Hospital
Ort
Einrichtung: Tan Tock Seng Hospital
Standort Länder

Singapore

Überprüfungsdatum

April 2017

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: Verum acupuncture

Art: Active Comparator

Beschreibung: 10 sessions of verum acupuncture

Etikette: Placebo acupuncture

Art: Placebo Comparator

Beschreibung: 10 sessions of placebo acupuncture via use of placebo acupuncture needles

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Beschreibung des Interventionsmodells: 2 arm study comparing acupuncture with sham

Hauptzweck: Treatment

Maskierung: Double (Participant, Outcomes Assessor)

Quelle: ClinicalTrials.gov