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

Completed
Conditions
Fibromyalgia Syndrome
Registration Number
NCT01389336
Lead Sponsor
Andreas Michalsen
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
31
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fibromyalgia Impact Questionnaire (FIQ)max. 3 weeks

Change in FIQ after completion of IPD-treatment

Secondary Outcome Measures
NameTimeMethod
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 painmax 3 weeks
Likert-Scalesmax 3 weeks
FIQ6 month
FFBH, STAI, POMS, SF-36, VAS, Likert-Scales.6 month

Trial Locations

Locations (1)

Immanuel Hospital Berlin

🇩🇪

Berlin, Germany

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