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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02587754 |
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Date of registration:
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16/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Acupuncture in the Treatment of Fatigue in Parkinson's Disease
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Scientific title:
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Acupuncture in the Treatment of Fatigue in Parkinson's Disease: a Pilot Randomized Controlled Study |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02587754 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Keng H Kong, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tan Tock Seng Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
21 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Fatigue
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Intervention(s)
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Device: Acupuncture
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Primary Outcome(s)
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General Fatigue score of the Multidimensional Fatigue Inventory
[Time Frame: General Fatigue score of the Multidimensional Fatigue Inventory at week 5]
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Secondary Outcome(s)
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Geriatric Depression Scale (GDS)
[Time Frame: GDS score at week 5]
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Unified Parkinson's Disease Rating Scale (UPDRS)
[Time Frame: UPDRS score at week 5]
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Parkinson's Disease Questionnaire-39 (PD 39).
[Time Frame: PD 39 score at week 9]
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General Fatigue score of the Multidimensional Fatigue Inventory
[Time Frame: General Fatigue score of the Multidimensional Fatigue Inventory at week 9]
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Geriatric Depression Scale (GDS)
[Time Frame: GDS score at week 9]
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Parkinson's Disease Questionnaire-39 (PD 39).
[Time Frame: PD 39 score at week 5]
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Unified Parkinson's Disease Rating Scale (UPDRS)
[Time Frame: UPDRS score at week 9]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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