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

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. Identifier: NCT01389336
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : May 8, 2013
Dr.Heinz Horst Deichmann Foundation,Essen,Germany
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany

July 6, 2011
July 8, 2011
May 8, 2013
July 2011
May 2013   (Final data collection date for primary outcome measure)
Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: max. 3 weeks ]
Change in FIQ after completion of IPD-treatment
Same as current
Complete list of historical versions of study NCT01389336 on Archive Site
  • Functional Hanover Questionnaire (FFBH) [ Time Frame: max. 3 weeks ]
  • State Trait Anxiety Inventory (STAI) [ Time Frame: max. 3 weeks ]
  • Profile of Mood States (POMS) [ Time Frame: max. 3 weeks ]
  • Short Form 36 Health Survey (SF-36) [ Time Frame: max. 3 weeks ]
  • VAS for pain [ Time Frame: max 3 weeks ]
  • Likert-Scales [ Time Frame: max 3 weeks ]
  • FIQ [ Time Frame: 6 month ]
  • FFBH, STAI, POMS, SF-36, VAS, Likert-Scales. [ Time Frame: 6 month ]
Same as current
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Add-on Complex Ayurvedic Treatment in Fibromyalgia-Syndrome Compared to Standard Care Alone
Kontrollierte Klinische Nicht-randomisierte Pilotstudie Zur Komplexen Āyurveda-Therapie Beim Fibromyalgiesyndrom im Vergleich Zur Konventionellen Standardbehandlung
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.
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Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Men and Women with Fibromyalgia-Syndrome between 18 und 70 years of age
Fibromyalgia Syndrome
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  • 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.
Kessler CS, Ostermann T, Meier L, Stapelfeldt E, Schütte S, Duda J, Michalsen A. Additive Complex Ayurvedic Treatment in Patients with Fibromyalgia Syndrome Compared to Conventional Standard Care Alone: A Nonrandomized Controlled Clinical Pilot Study (KAFA Trial). Evid Based Complement Alternat Med. 2013;2013:751403. doi: 10.1155/2013/751403. Epub 2013 Sep 1.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Andreas Michalsen, Charite University, Berlin, Germany
Andreas Michalsen
Dr.Heinz Horst Deichmann Foundation,Essen,Germany
Principal Investigator: Andreas Michalsen, Prof. Dr. Charité Medical University Berlin Germany
Charite University, Berlin, Germany
May 2013