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

Completed (inferred)Relapsing MSISRCTN34352011

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What it measured

Main measures

  • 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

    Immune response

Other measures (1)

  • 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

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 and over

Show the full criteria

Inclusion criteria

Inclusion: 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 Exclusion: 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

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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History

    1. Started

      May 2017

    2. Finished

      Nov 2017

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