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

July 6, 2011
May 7, 2013
July 2011
May 2013   (final data collection date for primary outcome measure)
Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: max. 3 weeks ] [ Designated as safety issue: No ]
Change in FIQ after completion of IPD-treatment
Same as current
Complete list of historical versions of study NCT01389336 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Fibromyalgia Syndrome
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01389336
KAFA
Yes
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

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