Clinical trial NCT01864707: Acupuncture or MBSR for Patients With Fatigue and MS
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Multiple Sclerosis
Keywords: multiple sclerosis, fatigue
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: fatigue severity scale
timeFrame: 12 weeks
Secondary outcomes:
measure: fatigue severity scale
timeFrame: 26 weeks
measure: modified fatigue impact scale
timeFrame: baseline, 8 weeks, 26 weeks
measure: therapy response rates
timeFrame: 12 weeks
measure: expanded disability status scale
timeFrame: baseline, 12 weeks, 26 weeks
measure: multipe sclerosis functional composite scale
timeFrame: baseline, 12 weeks, 26 weeks
measure: beck depression inventory II
timeFrame: baseline, 12 weeks, 26 weeks
measure: Body efficacy expectation
timeFrame: baseline, 12 weeks, 26 weeks
measure: SF-12
timeFrame: baseline, 12 weeks, 26 weeks
measure: HAQUAMS
timeFrame: baseline, 12 weeks, 26 weeks
measure: Costs
timeFrame: baseline, 12 weeks, 26 weeks
measure: overall treatment effect
timeFrame: 12 weeks, 26 weeks
measure: immune parameters
timeFrame: baseline, 12 weeks, 26 weeks
measure: number of serious adverse events
timeFrame: 12 weeks, 26 weeks
measure: number of suspected adverse reactions
timeFrame: 12 weeks, 26 weeks
Other outcomes:
measure: fMRI
timeFrame: baseline, 12 weeks, 26 weeks
measure: Dynamics of saccade parameters
timeFrame: baseline, 12 weeks, 26 weeks, and directly after one acupuncture session
measure: Qualitative interviews regarding therapy
timeFrame: 26 weeks
Locations:
city: Berlin
country: Germany
facility: The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
name: Claudia M Witt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
name: Friedemann Paul, MD
role: PRINCIPAL_INVESTIGATOR
References: