Condition category
Nervous System Diseases
Date applied
07/08/2019
Date assigned
28/08/2019
Last edited
22/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.southbaylo.edu

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

Publication citations

Additional files

Editorial Notes

22/08/2019: Trial's existence confirmed by Institutional Review Board.