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
  Purpose

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
Fibromyalgia Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: max. 3 weeks ] [ Designated as safety issue: No ]
    Change in FIQ after completion of IPD-treatment


Secondary Outcome Measures:
  • 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 ]

Enrollment: 31
Study Start Date: July 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Andreas Michalsen, Prof. Dr. Andreas Michalsen, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01389336     History of Changes
Other Study ID Numbers: KAFA
Study First Received: July 6, 2011
Last Updated: May 7, 2013
Health Authority: Germany: Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 21, 2014