NCT02587754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2017

Completed
Last Updated

July 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

October 16, 2015

Last Update Submit

July 6, 2017

Conditions

Parkinson DiseaseFatigue

Outcome Measures

Primary Outcomes (1)

  • General Fatigue score of the Multidimensional Fatigue Inventory

    Measure of fatigue

    General Fatigue score of the Multidimensional Fatigue Inventory at week 5

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Other Outcomes (1)

  • Adverse events

    Adverse events will be captured up to 9 weeks

Study Arms (2)

Verum acupuncture

ACTIVE COMPARATOR

10 sessions of verum acupuncture

Device: Acupuncture

Placebo acupuncture

PLACEBO COMPARATOR

10 sessions of placebo acupuncture via use of placebo acupuncture needles

Device: Acupuncture

Interventions

AcupunctureDEVICE

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

Placebo acupunctureVerum acupuncture

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Parkinson DiseaseFatigue

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Keng H Kong, MBBS

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 arm study comparing acupuncture with sham
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 27, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2017

Study Completion

April 27, 2017

Last Updated

July 11, 2017

Record last verified: 2017-04

Locations

SG(1)