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

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

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.

Condition or disease
Fibromyalgia Syndrome

Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Kontrollierte Klinische Nicht-randomisierte Pilotstudie Zur Komplexen Āyurveda-Therapie Beim Fibromyalgiesyndrom im Vergleich Zur Konventionellen Standardbehandlung
Study Start Date : July 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: max. 3 weeks ]
    Change in FIQ after completion of IPD-treatment


Secondary Outcome Measures :
  1. Functional Hanover Questionnaire (FFBH) [ Time Frame: max. 3 weeks ]
  2. State Trait Anxiety Inventory (STAI) [ Time Frame: max. 3 weeks ]
  3. Profile of Mood States (POMS) [ Time Frame: max. 3 weeks ]
  4. Short Form 36 Health Survey (SF-36) [ Time Frame: max. 3 weeks ]
  5. VAS for pain [ Time Frame: max 3 weeks ]
  6. Likert-Scales [ Time Frame: max 3 weeks ]
  7. FIQ [ Time Frame: 6 month ]
  8. FFBH, STAI, POMS, SF-36, VAS, Likert-Scales. [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men and Women with Fibromyalgia-Syndrome between 18 und 70 years of age
Criteria

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

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): NCT01389336


Locations
Germany
Immanuel Hospital Berlin
Berlin, Germany, 14109
Sponsors and Collaborators
Andreas Michalsen
Dr.Heinz Horst Deichmann Foundation,Essen,Germany
Investigators
Principal Investigator: Andreas Michalsen, Prof. Dr. Charité Medical University Berlin Germany

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andreas Michalsen, Prof. Dr. Andreas Michalsen, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01389336     History of Changes
Other Study ID Numbers: KAFA
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013

Keywords provided by Andreas Michalsen, Charite University, Berlin, Germany:
Fibromyalgia Syndrome
Fibromyalgia
Ayurveda
Traditional Indian Medicine
CAM
Pain
Chronic Widespread Pain

Additional relevant MeSH terms:
Syndrome
Fibromyalgia
Myofascial Pain Syndromes
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases