Plain English Summary
Background and study aims
The aim of this study is to investigate the effects of acupuncture and qigong meditation on non-motor symptoms of Idiopathic Parkinson’s Disease (PD).
Who can participate?
Patients with idiopathic PD taking anti-Parkinson medications which remained unchanged until the end of this study
What does the study involve?
Participants are randomly allocated to be treated with either qigong meditation with acupuncture, or qigong meditation alone. The participants’ level of discomfort in their daily lives caused by non-motor symptoms from idiopathic PD are evaluated before treatment, after the final treatment, and one month after the final treatment as a follow-up.
What are the possible benefits and risks of participating?
Participants may not benefit directly, but the study will help to increase the knowledge on acupuncture, meditation, and Asian medicine. By participating in this research it is possible that participants will be at greater risk than they would otherwise be. There is, for example, a risk that their condition will not get better and that the new medicine or treatment doesn't work. If, however, the medicine or treatment is not working, the researchers will give the medication or treatment routinely offered to make them more comfortable. While the possibility of this happening is very low, participants should still be aware of the possibility. Acupuncture can also cause pain, bleeding, blue and some temporary swelling around the place where the needles are injected. It is possible that it may also cause some problems that the researchers are not aware of. However, they will follow participants closely and keep track of any unwanted effects or any problems.
Where is the study run from?
South Baylo University (USA)
When is the study starting and how long is it expected to run for?
January 2018 to March 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Young Lee
hobslee2001@southbaylo.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Young Lee
ORCID ID
http://orcid.org/0000-0002-7064-3146
Contact details
2727 W 6th Ave
Los Angeles
90057
United States of America
+1 (0)213 738 1974
hobslee2001@southbaylo.edu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
SBU-010418RC
Study information
Scientific title
Effects of acupuncture and qigong meditation on non-motor symptoms of Parkinson’s Disease
Acronym
Study hypothesis
Acupuncture and qigong meditation help to improve neuro-degeneration issue.
Ethics approval
Approved 04/01/2018, South Baylo University Institutional Review Board (IRB) (2727 W. 6th Street, Los Angeles, CA 90057, USA; Tel: +1 (0)714 533 6077; Email: edfollick@southbaylo.edu), ref: 050219-1
Study design
Randomised controlled double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Parkinson’s disease
Intervention
Participants are randomized according to the stratified randomization method of Vickers. Participants are stratified into two types, that is, E group and C group. For each type, the Random Number Generator from random.org and relevant concealed envelope method will be used to allocate participants into group ‘E’ (n=10) treated with Qigong meditation with acupuncture for 5 minutes, and group ‘C’ (n=11) treated with Qigong meditation for 50 minutes. All of the participants and practitioners are blinded.
Four acupuncture points were used: GB-20, LI-4, DU-14, and DU-16. The Qigong meditation procedure consisted of breathing techniques, healing meditation practice, and qigong for transferring energy to areas of the olfactory tract through the mesolimbic and mesocortical pathway, for up to 50 minutes.
Participants with PD are assessed with a series of specialized scales before treatment, including nonmotor symptoms and quality of life like olfactory disorder. Participants in all groups were assessed prior to the first treatment, after the 12th treatment, and one month after treatment as a follow-up.
Statistical analysis was performed using R version 3.5.1 (2018-07-02) – "Feather Spray"49. after applying Kolmogorov-Smirnov test and Shapiro-Wilk Test to check normality, Paired t-test and Independent t-test or Wilcoxon signed rank test and Mann-Whitney U test were performed to evaluate the statistical significance. Generalised linear repeated mixed model was employed to analyse the missing data caused mostly due to noncompliance. The level set for statistical significance was 0.05.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Measured prior to the first treatment, after twelfth treatment, and one month after treatment:
1. Nonmotor symptoms measured using Unified Parkinson’s Disease Rating Scale (UPDRS)
2. Olfactory function measured using Test of Smell Identification (TSI)
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
04/01/2018
Overall trial end date
30/03/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosed with idiopathic PD based on UK Parkinson’s Disease Society Brain Bank criteria
2. Taking anti-Parkinson medications which remained unchanged until the end of this study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
21
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
04/01/2018
Recruitment end date
10/10/2018
Locations
Countries of recruitment
United States of America
Trial participating centre
South Baylo University
2727 W 6th Ave
Los Angeles
90057
United States of America
Sponsor information
Organisation
South Baylo University
Sponsor details
2727 W 6th Ave
Los Angeles
90057
United States of America
+1 (0)213 738 1974
hobslee2001@gmail.com
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in an open-access journal
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Young Lee (hobslee2001@southbaylo.edu)
Intention to publish date
30/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list