Effects of acupuncture and qigong meditation on non-motor symptoms of Parkinson’s Disease

ISRCTN ISRCTN12863628
DOI https://doi.org/10.1186/ISRCTN12863628
Secondary identifying numbers SBU-010418RC
Submission date
07/08/2019
Registration date
28/08/2019
Last edited
22/08/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Young Lee
Scientific

2727 W 6th Ave
Los Angeles
90057
United States of America

ORCiD logoORCID ID 0000-0002-7064-3146
Phone +1 (0)213 738 1974
Email hobslee2001@southbaylo.edu

Study information

Study designRandomised controlled double-blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleEffects of acupuncture and qigong meditation on non-motor symptoms of Parkinson’s Disease
Study objectivesAcupuncture and qigong meditation help to improve neuro-degeneration issue.
Ethics approval(s)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
Health condition(s) or problem(s) studiedParkinson’s disease
InterventionParticipants 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 typeMixed
Primary outcome measureMeasured 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 measuresThere are no secondary outcome measures
Overall study start date04/01/2018
Completion date30/03/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants21
Key inclusion criteria1. 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
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment04/01/2018
Date of final enrolment10/10/2018

Locations

Countries of recruitment

  • United States of America

Study participating centre

South Baylo University
2727 W 6th Ave
Los Angeles
90057
United States of America

Sponsor information

South Baylo University
University/education

2727 W 6th Ave
Los Angeles
90057
United States of America

Phone +1 (0)213 738 1974
Email hobslee2001@gmail.com
Website www.southbaylo.edu
ROR logo "ROR" https://ror.org/0197qh103

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in an open-access journal
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Young Lee (hobslee2001@southbaylo.edu)

Editorial Notes

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