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

May 7, 2013 updated by: Andreas Michalsen

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14109
        • Immanuel Hospital Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: max. 3 weeks
Change in FIQ after completion of IPD-treatment
max. 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional Hanover Questionnaire (FFBH)
Time Frame: max. 3 weeks
max. 3 weeks
State Trait Anxiety Inventory (STAI)
Time Frame: max. 3 weeks
max. 3 weeks
Profile of Mood States (POMS)
Time Frame: max. 3 weeks
max. 3 weeks
Short Form 36 Health Survey (SF-36)
Time Frame: max. 3 weeks
max. 3 weeks
VAS for pain
Time Frame: max 3 weeks
max 3 weeks
Likert-Scales
Time Frame: max 3 weeks
max 3 weeks
FIQ
Time Frame: 6 month
6 month
FFBH, STAI, POMS, SF-36, VAS, Likert-Scales.
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andreas Michalsen

Collaborators

Dr.Heinz Horst Deichmann Foundation,Essen,Germany

Investigators

  • Principal Investigator: Andreas Michalsen, Prof. Dr., Charité Medical University Berlin Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 6, 2011

First Submitted That Met QC Criteria

July 6, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

May 8, 2013

Last Update Submitted That Met QC Criteria

May 7, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAFA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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