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Completed

NCT Number: NCT01389336

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

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.

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Key information

Conditions

Fibromyalgia Syndrome Chronic Pain Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Immanuel Hospital Berlin

Berlin, State of Berlin, 14109, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: max. 3 weeks

    Change in FIQ after completion of IPD-treatment

Secondary outcomes

  1. Functional Hanover Questionnaire (FFBH)

    Time frame: max. 3 weeks

  2. State Trait Anxiety Inventory (STAI)

    Time frame: max. 3 weeks

  3. Profile of Mood States (POMS)

    Time frame: max. 3 weeks

  4. Short Form 36 Health Survey (SF-36)

    Time frame: max. 3 weeks

  5. VAS for pain

    Time frame: max 3 weeks

  6. Likert-Scales

    Time frame: max 3 weeks

  7. FIQ

    Time frame: 6 month

  8. FFBH, STAI, POMS, SF-36, VAS, Likert-Scales.

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Andreas Michalsen

Other

Collaborators

  • Dr.Heinz Horst Deichmann Foundation,Essen,Germany

Registry information

Official study title

Kontrollierte Klinische Nicht-randomisierte Pilotstudie Zur Komplexen Āyurveda-Therapie Beim Fibromyalgiesyndrom im Vergleich Zur Konventionellen Standardbehandlung

Acronym: KAFA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 8, 2011
Registry last updated
May 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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