Acupuncture or MBSR for Patients With Fatigue and MS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial on the Efficacy of Acupuncture and the Efficacy of Mindfulness-Based Stress Reduction (MBSR) in Patients With Multiple Sclerosis Suffering From Fatigue

Conditions
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Fatigue, Multiple Sclerosis

Intervention / Treatment
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* Other: Usual care + acupuncture
* Other: usual care+mbsr
* Other: usual care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: usual care + acupuncture<br>standardized acupuncture treatment in addition to usual care | Other: Usual care + acupuncture<br>* Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care<br>|
| Experimental: usual care+mbsr<br>mindfulness based stress reduction in addition to usual care not recruiting anymore | Other: usual care+mbsr<br>* Patients of this group receive mindfulness based stress reduction in addition to usual care<br>|
| Active Comparator: usual care<br>usual care without additional treatment | Other: usual care<br>* Patients in this group will follow the same treatment for fatigue they received at study entry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue severity scale |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | baseline, 12 weeks, 26 weeks | 
| SF-12 |  | baseline, 12 weeks, 26 weeks | 
| HAQUAMS |  | 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. | baseline, 12 weeks, 26 weeks | 
| overall treatment effect |  | 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. | baseline, 12 weeks, 26 weeks | 
| number of serious adverse events |  | 12 weeks, 26 weeks | 
| number of suspected adverse reactions |  | 12 weeks, 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, fatigue