Add-on Complex Ayurvedic Treatment in Fibromyalgia-Syndrome Compared to Standard Care Alone (KAFA)

This study has been completed.

Sponsor:

Collaborator:

Dr.Heinz Horst Deichmann Foundation,Essen,Germany

Information provided by (Responsible Party):

Andreas Michalsen, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01389336

First received: July 6, 2011

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 6, 2011

Last Updated Date

May 7, 2013

Start Date ^ICMJE

July 2011

Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: max. 3 weeks ] [ Designated as safety issue: No ]

Change in FIQ after completion of IPD-treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01389336 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Functional Hanover Questionnaire (FFBH) [ Time Frame: max. 3 weeks ] [ Designated as safety issue: No ]
State Trait Anxiety Inventory (STAI) [ Time Frame: max. 3 weeks ] [ Designated as safety issue: No ]
Profile of Mood States (POMS) [ Time Frame: max. 3 weeks ] [ Designated as safety issue: No ]
Short Form 36 Health Survey (SF-36) [ Time Frame: max. 3 weeks ] [ Designated as safety issue: No ]
VAS for pain [ Time Frame: max 3 weeks ] [ Designated as safety issue: No ]
Likert-Scales [ Time Frame: max 3 weeks ] [ Designated as safety issue: No ]
FIQ [ Time Frame: 6 month ] [ Designated as safety issue: No ]
FFBH, STAI, POMS, SF-36, VAS, Likert-Scales. [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Add-on Complex Ayurvedic Treatment in Fibromyalgia-Syndrome Compared to Standard Care Alone

Official Title ^ICMJE

Kontrollierte Klinische Nicht-randomisierte Pilotstudie Zur Komplexen Āyurveda-Therapie Beim Fibromyalgiesyndrom im Vergleich Zur Konventionellen Standardbehandlung

Brief Summary

The aim of this study is to evaluate the effectiveness of an additive complex āyurvedic diagnosis and treatment compared to conventional standard care alone in stationary patients with Fibromyalgia Syndrome.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Men and Women with Fibromyalgia-Syndrome between 18 und 70 years of age

Condition ^ICMJE

Fibromyalgia Syndrome

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Add-on Ayurveda - Group
In the Āyurveda add-on-group 20 patients will receive individualized treatment according to the Āyurveda diagnosis which may include manual treatments, massages, dietary advice, specific consideration of selected food items, āyurvedic lifestyle & yoga posture advice and daily self-applied massage on top of standard care.
Standard Care
20 Patients will receive the individually adjusted complex conventional standard care according to the current AWMF-guidelines including physiotherapy, occupational therapy, specific pain therapy and psychotherapy.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2013

Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

informed consent
age between 18 and 70 years
FMS according to current guidelines

Exclusion Criteria:

change of pharmacological FMS treatment >= 6 weeks before inclusion
pregnancy or breat feeding
acute psychiatric condition
severe acute somatic disease
severechronic comorbidity
obesity WHO >= II degree
bloodcoagulation-disease
intake of opiods
current treatment with hyperthermia
simultaneous participant in other trial
praticipation in other trial during 6 month before inclusion

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01389336

Other Study ID Numbers ^ICMJE

KAFA

Has Data Monitoring Committee

Yes

Responsible Party

Andreas Michalsen, Charite University, Berlin, Germany

Study Sponsor ^ICMJE

Andreas Michalsen

Collaborators ^ICMJE

Dr.Heinz Horst Deichmann Foundation,Essen,Germany

Investigators ^ICMJE

Principal Investigator:

Andreas Michalsen, Prof. Dr.

Charité Medical University Berlin Germany

Information Provided By

Charite University, Berlin, Germany

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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