Acupuncture or MBSR for Patients With Fatigue and MS

Not Applicable

Completed

• Conditions: Fatigue; Multiple Sclerosis
• Interventions: Other: Usual care + acupuncture; Other: usual care; Other: usual care+mbsr

• Registration Number: NCT01864707
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-30
• Primary Completion: 2015-06
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual care + acupuncture	Usual care + acupuncture	standardized acupuncture treatment in addition to usual care
usual care	usual care	usual care without additional treatment
usual care+mbsr	usual care+mbsr	mindfulness based stress reduction in addition to usual care not recruiting anymore

Primary Outcome Measures

Name	Time	Method
fatigue severity scale	12 weeks

Secondary Outcome Measures

Name	Time	Method
SF-12	baseline, 12 weeks, 26 weeks
therapy response rates	12 weeks
multipe sclerosis functional composite scale	baseline, 12 weeks, 26 weeks
beck depression inventory II	baseline, 12 weeks, 26 weeks
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 suspected adverse reactions	12 weeks, 26 weeks
fatigue severity scale	26 weeks
modified fatigue impact scale	baseline, 8 weeks, 26 weeks
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.
expanded disability status scale	baseline, 12 weeks, 26 weeks
overall treatment effect	12 weeks, 26 weeks
number of serious adverse events	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.

Trial Locations

Locations (1)

The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany