Acupuncture or MBSR for Patients With Fatigue and MS

Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864707
• Other study ID #: MS-Fatigue-13
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: January 27, 2016
• Start date: April 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Usual care + acupuncture
Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care
• usual care+mbsr
Patients of this group receive mindfulness based stress reduction in addition to usual care
• usual care
Patients in this group will follow the same treatment for fatigue they received at study entry

Locations

Country	Name	City	State
Germany	The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fMRI	e.g. functional connectivity in a subgroup of 20 subjects in each group	baseline, 12 weeks, 26 weeks	No
Other	Dynamics of saccade parameters	Eye movement analysis will be performed according established standards (Finke et al, J Neurol 2012)	baseline, 12 weeks, 26 weeks, and directly after one acupuncture session	No
Other	Qualitative interviews regarding therapy	Part of the patients will be interviewed about the therapies.	26 weeks	No
Primary	fatigue severity scale		12 weeks	No
Secondary	fatigue severity scale		26 weeks	No
Secondary	modified fatigue impact scale		baseline, 8 weeks, 26 weeks	No
Secondary	therapy response rates		12 weeks	No
Secondary	expanded disability status scale		baseline, 12 weeks, 26 weeks	No
Secondary	multipe sclerosis functional composite scale		baseline, 12 weeks, 26 weeks	No
Secondary	beck depression inventory II		baseline, 12 weeks, 26 weeks	No
Secondary	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.	baseline, 12 weeks, 26 weeks	No
Secondary	SF-12		baseline, 12 weeks, 26 weeks	No
Secondary	HAQUAMS		baseline, 12 weeks, 26 weeks	No
Secondary	Costs	Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.	baseline, 12 weeks, 26 weeks	No
Secondary	overall treatment effect		12 weeks, 26 weeks	No
Secondary	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.	baseline, 12 weeks, 26 weeks	No
Secondary	number of serious adverse events		12 weeks, 26 weeks	Yes
Secondary	number of suspected adverse reactions		12 weeks, 26 weeks	Yes