Status:
COMPLETED
Acupuncture or MBSR for Patients With Fatigue and MS
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Fatigue
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 scle...
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 whe...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01864707
Start Date
April 1 2013
End Date
October 1 2015
Last Update
January 29 2016
Active Locations (1)
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1
The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117