Fatigue, Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, fatigue
Brief summary
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.
Detailed description
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.
Interventions
Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care
OTHERusual care+mbsr
Patients of this group receive mindfulness based stress reduction in addition to usual care
OTHERusual care
Patients in this group will follow the same treatment for fatigue they received at study entry
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* female or male * 18 to 65 years of age * able to give oral and signed written informed consent * clinical diagnosis of multiple sclerosis * fatigue in multiple sclerosis for at least 3 months * other stable pre-study treatment with respect to target symptom fatigue for at least 3 months before inclusion * stable immunomodulatory or immunosuppressive therapy or stable no such a therapy for at least the 3 months before inclusion * fatigue score of ≥4 on the Fatigue Severity Scale at inclusion * patient's mental and physical ability to participate in the trial * willingness to be randomised, to attend visits, to complete questionnaires, and willingness to participate and fMRI measurements
Exclusion criteria
* fatigue because of a malignant disease * acute relapse or cortisone therapy therapy in the last 30 days before inclusion * EDSS (Extended disability status scale) \> 6 * fatigue specific acupuncture in the last 12 months * during the last 12 months performing of MBSR exercises learnt in the past * change of immunomodulatory or immunosuppressive therapy during the 3 months before inclusion * other new therapies are planned which could have a positive effect on fatigue (e.g. exercise, acupuncture, relaxation therapy) * for female patients: pregnancy or anticipated pregnancy during the intervention period * severe acute and or chronic disease which does not allow participation in the therapy * other limitations which do not allow participation in the therapy * alcohol or substance abuse * parallel participation in another clinical trial * BDI \> 29 * contra indications for fMRI session (e.g. metal clips)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fatigue severity scale | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body efficacy expectation | baseline, 12 weeks, 26 weeks | 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. |
| immune parameters | baseline, 12 weeks, 26 weeks | 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. |
| number of serious adverse events | 12 weeks, 26 weeks | — |
| number of suspected adverse reactions | 12 weeks, 26 weeks | — |
| fatigue severity scale | 26 weeks | — |
| modified fatigue impact scale | baseline, 8 weeks, 26 weeks | — |
| therapy response rates | 12 weeks | — |
| expanded disability status scale | baseline, 12 weeks, 26 weeks | — |
| multipe sclerosis functional composite scale | baseline, 12 weeks, 26 weeks | — |
| beck depression inventory II | baseline, 12 weeks, 26 weeks | — |
| SF-12 | baseline, 12 weeks, 26 weeks | — |
| HAQUAMS | baseline, 12 weeks, 26 weeks | — |
| Costs | baseline, 12 weeks, 26 weeks | Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires. |
| overall treatment effect | 12 weeks, 26 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative interviews regarding therapy | 26 weeks | Part of the patients will be interviewed about the therapies. |
| fMRI | baseline, 12 weeks, 26 weeks | e.g. functional connectivity in a subgroup of 20 subjects in each group |
| Dynamics of saccade parameters | baseline, 12 weeks, 26 weeks, and directly after one acupuncture session | Eye movement analysis will be performed according established standards (Finke et al, J Neurol 2012) |
Countries
Germany
Outcome results
None listed