Condition category
Nervous System Diseases
Date applied
22/10/2020
Date assigned
02/11/2020
Last edited
06/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Multiple sclerosis (MS) is a condition affecting the brain and spinal cord that causes problems with vision, arm or leg movement, sensation or balance. Cytokines have been found to play a role in the disease activity of MS. Previous studies indicate that acupuncture can affect cytokine levels in persons with other inflammatory diseases. The aim of this study is to investigate the effect of acupuncture on cytokine levels and health-related quality of life in patients with MS.

Who can participate?
Patients aged 18 or older with relapsing-remitting MS (RRMS) for at least 2 years, who have not changed disease-modifying treatment within the past 3 months and have not received acupuncture treatment within the past 3 months.

What does the study involve?
Participants will be randomly allocated to receive either real acupuncture, sham acupuncture or no acupuncture. The patients receiving acupuncture will receive a total of six treatments over a period of 4 weeks: two treatments in each of the first 2 weeks and one treatment in each of the following 2 weeks. Measurements will be taken at baseline, the day after the 4th treatment, the day after the final treatment, and at 4 weeks after the final treatment.

What are the possible benefits and risks of participating?
Participants will contribute to important research that may enhance the health and quality of life of themselves and other persons with MS. Acupuncture is generally a safe treatment associated with little or no side-effects. The following side-effects may occur: bruises and discomfort around the needling points. More rarely seen side-effects include nausea, malaise, drowsiness, a feeling of elation, dizziness and fainting. At the beginning of the treatment, symptoms may temporarily worsen. Blood sampling may cause small bruising and discomfort around the point of needle insertion. There is a minimal risk of infection in relation to blood sampling.

Where is the study run from?
The study is run from the Danish MS Society in cooperation with the Institute of Immunology and Microbiology at the University of Copenhagen (Denmark)

When is the study starting and how long is it expected to run for?
August 2016 to November 2017

Who is funding the study?
Danish National Board of Health and the Danish MS Society (Denmark)

Who is the main contact?
Lasse Skovgaard
lsk@scleroseforeningen.dk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lasse Skovgaard

ORCID ID

http://orcid.org/0000-0002-2439-2323

Contact details

Poul Bundgaards Vej 1
Valby
2500
Denmark
+45 (0)51629177
lsk@scleroseforeningen.dk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Effect of acupuncture on cytokine levels in persons with multiple sclerosis: a randomized controlled trial

Acronym

Study hypothesis

Cytokines have been found to play a role in disease activity in Multiple Sclerosis (MS), and studies indicate that acupuncture can affect cytokine levels in people with other inflammatory diseases. It is hypothesized that acupuncture will affect cytokine levels in the intervention group which will not be seen in the control groups.

Ethics approval

Approved 23/03/2017, The Danish Committee on Health Research Ethics (Ørestads Boulevard 5, bygn. 37K, st., 2300 København S, Denmark; +45 (0)72 21 68 55; vek@regionh.dk), ref: H-17004731

Study design

Single-blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet (in Danish)

Condition

Multiple sclerosis

Intervention

Participants are randomized into three groups: an intervention group receiving real acupuncture, a control group receiving sham acupuncture, and a second control group receiving no acupuncture. A simple randomization approach is used in which participants are assigned a random number between 0 and 1 using the Microsoft Excel RAND function. They are then placed in order from lowest to highest number and finally divided into groups in that order.

The acupuncture treatments are performed by two practitioners with university degrees in TCM as well as in Western medicine and the sessions take place in the clinics of the two acupuncturists.

Each patient from the two treatment groups (real acupuncture and sham treatment) receive a total of six treatments over a period of 4 weeks: two treatments in each of the first 2 weeks and one treatment in each of the following 2 weeks.

A standardized TCM treatment using ten acupuncture points has been developed to specifically target inflammation levels. The chosen acupuncture points are GV20, CV6, BL23 (bilateral), LI4 (bilateral) ST36 (bilateral), and SP6 (bilateral). These ten points are used in each treatment session in both treatment groups. Needles will be removed after 40 minutes, except for BL23 which will be removed after 20 minutes.

Streitberger Placebo needles will be used for the sham treatment.

In addition to the standard treatment, the acupuncturists can place additional needles to target specific symptoms reported by the participant. Any additional needles are removed after 20 minutes.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Cytokine plasma levels (IFNγ, IL-1β, IL-6, IL-8, IL-12p70, IL-13, TNFα, IL-10, IL-4, IL-2 and IL-17A) measured using the Mesoscale Multi-spot Assay System on blood samples taken at baseline, the day after the 4th treatment, the day after the final treatment, and at 4 weeks following the final treatment

Secondary outcome measures

Health-related quality of life (HRQoL) measured using the MS-specific Functional Assessment of Multiple Sclerosis (FAMS) instrument at baseline, after 4 weeks (following the last treatment), and at 4 weeks after the final treatment

Overall trial start date

01/08/2016

Overall trial end date

07/11/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Diagnosed with relapsing-remitting multiple sclerosis for a minimum of 2 years
3. Must be able to walk unassisted (equivalent to an EDSS of 6.5)
4. Must have been relapse-free for the past 3 months
5. If treated with disease-modifying medicine, treatment must have been unchanged for the past 3 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Total final enrolment

75

Participant exclusion criteria

1. Significant co-morbidities (heart disease, diabetes, Mb. Crohn or other) which may affect the immune system
2. Has received acupuncture treatment within the past 3 months

Recruitment start date

01/05/2017

Recruitment end date

30/06/2017

Locations

Countries of recruitment

Denmark

Trial participating centre

The Danish MS Society
Poul Bundgaards Vej 1
Valby
2500
Denmark

Sponsor information

Organisation

Scleroseforeningen

Sponsor details

Poul Bundgaards Vej 1
Valby
2500
Denmark
+45 (0)36463646
info@scleroseforeningen.dk

Sponsor type

Charity

Website

https://scleroseforeningen.dk/

Funders

Funder type

Government

Funder name

Sundhedsstyrelsen

Alternative name(s)

Danish Health and Medicines Authority, DHMA

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Denmark

Funder name

Scleroseforeningen

Alternative name(s)

Danish Multiple Sclerosis Society, Danish MS Society

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

Denmark

Results and Publications

Publication and dissemination plan

Study results will be published in a scientific peer-reviewed journal specializing in traditional and complementary treatment

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as the researchers don’t have a platform from which to share the data. The data is held by the Danish MS Society.

Intention to publish date

01/11/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/11/2020: Uploaded protocol (not peer reviewed) Version n/a, Date n/a. 28/10/2020: Trial's existence confirmed by The Danish Committee on Health Research Ethics.