Condition category
Nervous System Diseases
Date applied
21/11/2016
Date assigned
22/12/2016
Last edited
22/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare condition that affects the optic nerves and spinal cord. It is an autoimmune condition, which means that the body's immune system attacks healthy tissue leading to inflammation (swelling). An antibody against a protein called aquaporin-4 is present in the blood of up to 80% of people with NMOSD, which attacks aquaporin-4, leading to damage to the myelin sheath (the protective layer that surrounds nerve cells in the brain and spinal cord and helps transmit nerve signals). Over time, sufferers experience periods of lower disease activity (remission) and bouts where symptoms become much worse (relapse). In order to maintain remission, drugs that suppress the immune system, such as Azathioprine can be used. Acupuncture is an ancient Chinese medical technique which can be used to effectively treat a number of conditions. The aim of this study is to find out whether treatment with Azathioprine and acupuncture is more effective than treatment with Azathioprine alone in treating NMOSD.

Who can participate?
Patients with NMOSD in relatively stable stage of disease.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are treated with a therapeutic dose of medicine (Azathioprine) for three months. Those in the second group are treated with Azathioprine for three months as well as receiving acupuncture three times a week for two weeks a month for three months. At the start of the study and then again after three, six and 12 motnhs, participants have a blood sample taken which is tested for antibody levels as well as having their level of disability assessed.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part, but there should be benefits to future NMOSDs patients and also to the disease itself because the results of the study are likely to influence how NMOSDs is treated and broaden the method of treatments available. Patients can also get disease related counseling. The main risks of acupuncture are fainting, infection, pneumothorax (abnormal collection of air in the space around the lungs) and sticking of the needle. Therefore, the Acupuncture Centre will continue to follow its routine safety procedures while practicing acupuncture.

Where is the study run from?
Beijing Traditional Chinese Medical Hospital affiliated to Capital University (China)

When is study starting and how long is it expected to run for?
April 2016 to December 2018

Who is funding the study?
Beijing Municipal Hospital Authority (China)

Who is the main contact?
Dr. Chunchen Wang

Trial website

Contact information

Type

Public

Primary contact

Miss Chunchen Wang

ORCID ID

Contact details

Beijing Traditional Chinese Medical Hospital Affiliated to Capital Medical University
Meishuguan Hou Street No.23
Dongcheng District
Bejing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

Acupuncture as a disease modifying therapy for treatment in remission stage of neuromyelitis optics spectrum disorders: a prospective clinical randomised parallel trial

Acronym

Study hypothesis

Acupuncture is better than Azathioprine as a treatment in remission stage of neuromyelitis optics spectrum disorders.

Ethics approval

Medical Ethics Committee of Beijing Traditional Chinese Medicine Hospital affiliated to Capital Medical University. 14/03/2016, ref: 2016BL-019-01

Study design

Single-centre prospective randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Neuromyelitis optics spectrum disorders of remitting stage

Intervention

Participants are randomised to one of two groups using a computerised random number table.

Intervention group: Participants are treated with oral azathioprine at a dose of 2mg/Kg-D for three months in addition to receiving manual acupuncture three times a week, two weeks a month.
Accupoints used include:
Jiaji acupoints: back to the first thoracic lumbar spine to the fifth lumbar spine on both sides, after the middle of the midline beside 0.5 inches, one side of the 17 points, a total of 34 points on both sides
Hand and foot twelve acupoints: ShangWan, ZhongWan, XiaWan, TianShu, GuanYuan, NeiGuan, ZuSanLi
Add acupuncture points according to the accompanying symptoms:
Decreasing of visual acuity : CuanZhu , JingMing, fengchi , QiuHou, GuangMing
Dysphagia : LianQuan , FengChi , WanGu, YiFeng
Urinary disorders : ShuiDao, Cilia, Zhongji
Dysphoria: Tianshu, Zhongwan, Qihai

Control group: Participants are treated with oral azathioprine at a dose of 2mg/Kg-D for three months only.

Participants in both groups are followed up after three months, six months and one year.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Disability is measured using the Expanded disability scale score at baseline, 3, 6 and 12 months.

Secondary outcome measures

1. AQP4-IgG level is measured using cell transfection method at baseline and 3 months
2. Annual relapse rate is measured using computer formula at baseline, 3, 6 and 12 months

Overall trial start date

20/12/2016

Overall trial end date

28/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of neuromyelitis optics spectrum disorders in accordance with NMOSDs diagnostic criteria established by the international panel for NMO diagnosis (IPND) in 2015.
2. In remission stage (no acute progress, no corticosteroid therapy or immunoglobulin therapy, plasma exchange, stable condition without relapse signs)
3. Age of 18-75 years old
4. EDSS score less than 5
5. No other treatment with immunosuppressive drugs within 6 months or no other immunosuppressive drugs other than azathioprine
6. Provision of informed consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40 NMOSDs patients of remitting stage

Participant exclusion criteria

1. Oral azathioprine intolerant patients
2. History of severe allergies
3. Those who can not tolerate acupuncture
4. Clinically significant history of disease, blood disease, endocrine, metabolism, liver, lung, urinary system, nervous system, skin disease, other major primary disease and psychiatric disease
5. Malignant tumor
6. B type hepatitis
7. Pregnancy or lactation

Recruitment start date

01/04/2016

Recruitment end date

28/09/2017

Locations

Countries of recruitment

China

Trial participating centre

Beijing Traditional Chinese Medical Hospital affiliated to Capital University
Meishuguan Hou Street No.23 Dongcheng district
Beijing
100010
China

Sponsor information

Organisation

Beijing Traditional Chinese Medical Hospital Affiliated to Capital Medical University

Sponsor details

Meishuguan Hou Street No.23
Dongcheng District
Beijing
100010
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Beijing Municipal Hospital Authority

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of this study are intended to be published in a peer reviewed journal.

IPD Sharing plan:
The datasets generated and analysed during the current study will be included in the subsequent results publication.

Intention to publish date

30/06/2019

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes