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

NCT ID: NCT01389336

Last Updated: 2013-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-05-31

Brief Summary

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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

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Conditions

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Fibromyalgia Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr.Heinz Horst Deichmann Foundation,Essen,Germany

UNKNOWN

Sponsor Role collaborator

Andreas Michalsen

OTHER

Sponsor Role lead

Responsible Party

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Andreas Michalsen

Prof. Dr. Andreas Michalsen

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andreas Michalsen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charité Medical University Berlin Germany

Locations

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Immanuel Hospital Berlin

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 24073008 (View on PubMed)

Related Links

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http://www.immanuel.de

Hospital Website

http://www.charite.de

University Website

Other Identifiers

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KAFA

Identifier Type: -

Identifier Source: org_study_id

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