Acupuncture or MBSR for Patients With Fatigue and MS

NCT ID: NCT01864707

Last Updated: 2016-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-10-31

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.

Conditions

Fatigue; Multiple Sclerosis

Keywords

multiple sclerosis, fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

usual care + acupuncture

standardized acupuncture treatment in addition to usual care

Group Type: EXPERIMENTAL

Usual care + acupuncture

Intervention Type: OTHER

Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care

usual care+mbsr

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

Group Type: EXPERIMENTAL

usual care+mbsr

Intervention Type: OTHER

Patients of this group receive mindfulness based stress reduction in addition to usual care

usual care

usual care without additional treatment

Group Type: ACTIVE_COMPARATOR

usual care

Intervention Type: OTHER

Patients in this group will follow the same treatment for fatigue they received at study entry

Interventions

Usual care + acupuncture

Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care

Intervention Type: OTHER

usual care+mbsr

Patients of this group receive mindfulness based stress reduction in addition to usual care

Intervention Type: OTHER

usual care

Patients in this group will follow the same treatment for fatigue they received at study entry

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia M. Witt

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia M Witt, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin

Friedemann Paul, MD

Role: PRINCIPAL_INVESTIGATOR

The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin

Locations

The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

MS-Fatigue-13

Identifier Type: -

Identifier Source: org_study_id