ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01864707
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01864707
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Fatigue Multiple Sclerosis Other: Usual care + acupuncture Other: usual care+mbsr Other: usual care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: usual care + acupuncture
standardized acupuncture treatment in addition to usual care
Other: Usual care + acupuncture
Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care

Experimental: usual care+mbsr
mindfulness based stress reduction in addition to usual care not recruiting anymore
Other: usual care+mbsr
Patients of this group receive mindfulness based stress reduction in addition to usual care

Active Comparator: usual care
usual care without additional treatment
Other: usual care
Patients in this group will follow the same treatment for fatigue they received at study entry




Primary Outcome Measures :
  1. fatigue severity scale [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. fatigue severity scale [ Time Frame: 26 weeks ]
  2. modified fatigue impact scale [ Time Frame: baseline, 8 weeks, 26 weeks ]
  3. therapy response rates [ Time Frame: 12 weeks ]
  4. expanded disability status scale [ Time Frame: baseline, 12 weeks, 26 weeks ]
  5. multipe sclerosis functional composite scale [ Time Frame: baseline, 12 weeks, 26 weeks ]
  6. beck depression inventory II [ Time Frame: baseline, 12 weeks, 26 weeks ]
  7. Body efficacy expectation [ Time Frame: baseline, 12 weeks, 26 weeks ]
    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.

  8. SF-12 [ Time Frame: baseline, 12 weeks, 26 weeks ]
  9. HAQUAMS [ Time Frame: baseline, 12 weeks, 26 weeks ]
  10. Costs [ Time Frame: baseline, 12 weeks, 26 weeks ]
    Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.

  11. overall treatment effect [ Time Frame: 12 weeks, 26 weeks ]
  12. immune parameters [ Time Frame: baseline, 12 weeks, 26 weeks ]

    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.


  13. number of serious adverse events [ Time Frame: 12 weeks, 26 weeks ]
  14. number of suspected adverse reactions [ Time Frame: 12 weeks, 26 weeks ]

Other Outcome Measures:
  1. fMRI [ Time Frame: baseline, 12 weeks, 26 weeks ]
    e.g. functional connectivity in a subgroup of 20 subjects in each group

  2. Dynamics of saccade parameters [ Time Frame: baseline, 12 weeks, 26 weeks, and directly after one acupuncture session ]
    Eye movement analysis will be performed according established standards (Finke et al, J Neurol 2012)

  3. Qualitative interviews regarding therapy [ Time Frame: 26 weeks ]
    Part of the patients will be interviewed about the therapies.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864707


Locations
Germany
The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Claudia M Witt, MD Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
Principal Investigator: Friedemann Paul, MD The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin

Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01864707     History of Changes
Other Study ID Numbers: MS-Fatigue-13
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016

Keywords provided by Claudia M. Witt, Charite University, Berlin, Germany:
multiple sclerosis, fatigue

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms