search
Back to results

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

Primary Purpose

Fatigue, Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Usual care + acupuncture
usual care+mbsr
usual care
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring multiple sclerosis, fatigue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

usual care + acupuncture

usual care+mbsr

usual care

Arm Description

standardized acupuncture treatment in addition to usual care

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

usual care without additional treatment

Outcomes

Primary Outcome Measures

fatigue severity scale

Secondary Outcome Measures

fatigue severity scale
modified fatigue impact scale
therapy response rates
expanded disability status scale
multipe sclerosis functional composite scale
beck depression inventory II
Body efficacy expectation
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.
SF-12
HAQUAMS
Costs
Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.
overall treatment effect
immune parameters
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 serious adverse events
number of suspected adverse reactions

Full Information

First Posted
April 2, 2013
Last Updated
January 27, 2016
Sponsor
Charite University, Berlin, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT01864707
Brief Title
Acupuncture or MBSR for Patients With Fatigue and MS
Acronym
MS-Fatigue
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Multiple Sclerosis
Keywords
multiple sclerosis, fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care + acupuncture
Arm Type
Experimental
Arm Description
standardized acupuncture treatment in addition to usual care
Arm Title
usual care+mbsr
Arm Type
Experimental
Arm Description
mindfulness based stress reduction in addition to usual care not recruiting anymore
Arm Title
usual care
Arm Type
Active Comparator
Arm Description
usual care without additional treatment
Intervention Type
Other
Intervention Name(s)
Usual care + acupuncture
Intervention Description
Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care
Intervention Type
Other
Intervention Name(s)
usual care+mbsr
Intervention Description
Patients of this group receive mindfulness based stress reduction in addition to usual care
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
Patients in this group will follow the same treatment for fatigue they received at study entry
Primary Outcome Measure Information:
Title
fatigue severity scale
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
fatigue severity scale
Time Frame
26 weeks
Title
modified fatigue impact scale
Time Frame
baseline, 8 weeks, 26 weeks
Title
therapy response rates
Time Frame
12 weeks
Title
expanded disability status scale
Time Frame
baseline, 12 weeks, 26 weeks
Title
multipe sclerosis functional composite scale
Time Frame
baseline, 12 weeks, 26 weeks
Title
beck depression inventory II
Time Frame
baseline, 12 weeks, 26 weeks
Title
Body efficacy expectation
Description
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.
Time Frame
baseline, 12 weeks, 26 weeks
Title
SF-12
Time Frame
baseline, 12 weeks, 26 weeks
Title
HAQUAMS
Time Frame
baseline, 12 weeks, 26 weeks
Title
Costs
Description
Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.
Time Frame
baseline, 12 weeks, 26 weeks
Title
overall treatment effect
Time Frame
12 weeks, 26 weeks
Title
immune parameters
Description
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.
Time Frame
baseline, 12 weeks, 26 weeks
Title
number of serious adverse events
Time Frame
12 weeks, 26 weeks
Title
number of suspected adverse reactions
Time Frame
12 weeks, 26 weeks
Other Pre-specified Outcome Measures:
Title
fMRI
Description
e.g. functional connectivity in a subgroup of 20 subjects in each group
Time Frame
baseline, 12 weeks, 26 weeks
Title
Dynamics of saccade parameters
Description
Eye movement analysis will be performed according established standards (Finke et al, J Neurol 2012)
Time Frame
baseline, 12 weeks, 26 weeks, and directly after one acupuncture session
Title
Qualitative interviews regarding therapy
Description
Part of the patients will be interviewed about the therapies.
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia M Witt, MD
Organizational Affiliation
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Friedemann Paul, MD
Organizational Affiliation
The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Acupuncture or MBSR for Patients With Fatigue and MS

We'll reach out to this number within 24 hrs