The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis.
In multiple sclerosis, fatigue is the most common clinical symptom, reported by up to 97% of patients. No successful evidence-based therapy exists so far. The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis. We want to include 141 patients with multiple sclerosis and fatigue. Participants will be randomised into three groups to compare 1) usual care, 2) usual care plus standardised acupuncture, and 3) usual care plus mindfulness-based stress reduction. Treatment duration will be 12 weeks. The primary outcome is the Fatigue Severity Scale (FSS) after 12 weeks, follow-up measurement will be performed after 26 weeks. Secondary outcomes include other fatigue specific parameters, other MS specific parameters, cost, and physiological, immunological and functional magnetic resonance imaging parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care
Patients of this group receive mindfulness based stress reduction in addition to usual care
Patients in this group will follow the same treatment for fatigue they received at study entry
The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
fatigue severity scale
Time frame: 12 weeks
fatigue severity scale
Time frame: 26 weeks
modified fatigue impact scale
Time frame: baseline, 8 weeks, 26 weeks
therapy response rates
Time frame: 12 weeks
expanded disability status scale
Time frame: baseline, 12 weeks, 26 weeks
multipe sclerosis functional composite scale
Time frame: baseline, 12 weeks, 26 weeks
beck depression inventory II
Time frame: baseline, 12 weeks, 26 weeks
Body efficacy expectation
Body-Efficacy Expectation (BEE) is a scale to measure the conviction that one's body is able to deal with health-threatening factors by itself. It is a six items' scale developed in the Institute of Social Medicine, Epidemiology and Health Economics and not published, yet.
Time frame: baseline, 12 weeks, 26 weeks
SF-12
Time frame: baseline, 12 weeks, 26 weeks
HAQUAMS
Time frame: baseline, 12 weeks, 26 weeks
Costs
Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.
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Time frame: baseline, 12 weeks, 26 weeks
overall treatment effect
Time frame: 12 weeks, 26 weeks
immune parameters
PBMC and proliferationsassays, pro- and antiinflamatory cytokines, axonal damage marker such as neurofilaments and neurotrophic factors like BDNF possible influences on the immune system will be evaluated in an exploratory way.
Time frame: baseline, 12 weeks, 26 weeks
number of serious adverse events
Time frame: 12 weeks, 26 weeks
number of suspected adverse reactions
Time frame: 12 weeks, 26 weeks