Acupuncture or MBSR for Patients With Fatigue and MS (MS-Fatigue)

Charité University Medicine Berlin

Status: Completed

Conditions: Multiple Sclerosis; Fatigue

Treatments: Other: Usual care + acupuncture; Other: usual care+mbsr; Other: usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01864707

MS-Fatigue-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 3 patient groups

usual care + acupuncture

Experimental group

Description:

standardized acupuncture treatment in addition to usual care

Treatment:

Other: Usual care + acupuncture

usual care+mbsr

Experimental group

Description:

mindfulness based stress reduction in addition to usual care not recruiting anymore

Treatment:

Other: usual care+mbsr

usual care

Active Comparator group

Description:

usual care without additional treatment

Treatment:

Other: usual care