Add-on Complex Ayurvedic Treatment in Fibromyalgia-Syndrome Compared to Standard Care Alone
KAFA
Kontrollierte Klinische Nicht-randomisierte Pilotstudie Zur Komplexen Āyurveda-Therapie Beim Fibromyalgiesyndrom im Vergleich Zur Konventionellen Standardbehandlung
1 other identifier
observational
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 6, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 8, 2013
May 1, 2013
1.8 years
July 6, 2011
May 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fibromyalgia Impact Questionnaire (FIQ)
Change in FIQ after completion of IPD-treatment
max. 3 weeks
Secondary Outcomes (8)
Functional Hanover Questionnaire (FFBH)
max. 3 weeks
State Trait Anxiety Inventory (STAI)
max. 3 weeks
Profile of Mood States (POMS)
max. 3 weeks
Short Form 36 Health Survey (SF-36)
max. 3 weeks
VAS for pain
max 3 weeks
- +3 more secondary outcomes
Study Arms (2)
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 Criteria
Men and Women with Fibromyalgia-Syndrome between 18 und 70 years of age
You may qualify if:
- informed consent
- age between 18 and 70 years
- FMS according to current guidelines
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Immanuel Hospital Berlin
Berlin, State of Berlin, 14109, Germany
Related Publications (1)
Kessler CS, Ostermann T, Meier L, Stapelfeldt E, Schutte 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.
PMID: 24073008DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Michalsen, Prof. Dr.
Charité Medical University Berlin Germany
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. Andreas Michalsen
Study Record Dates
First Submitted
July 6, 2011
First Posted
July 8, 2011
Study Start
July 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
May 8, 2013
Record last verified: 2013-05