Fibromyalgia SyndromeKAFANCT01389336
Add-on Complex Ayurvedic Treatment in Fibromyalgia-Syndrome Compared to Standard Care Alone
An observational study of Fibromyalgia Syndrome, run by Andreas Michalsen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia Syndrome
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and Women with Fibromyalgia-Syndrome between 18 und 70 years of age
Who may be able to join
- informed consent
- age between 18 and 70 years
- FMS according to current guidelines
Who cannot join
- 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
Show all 11Show fewer
- bloodcoagulation-disease
- intake of opiods
- current treatment with hyperthermia
- simultaneous participant in other trial
- praticipation in other trial during 6 month before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia Syndrome, Fibromyalgia, Ayurveda, Traditional Indian Medicine, CAM, Pain, Chronic Widespread Pain
- Medical subject headings
- Fibromyalgia, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ)
Change in FIQ after completion of IPD-treatment
Measured: max. 3 weeks
Secondary outcomes (8)
Functional Hanover Questionnaire (FFBH)
Measured: max. 3 weeks
State Trait Anxiety Inventory (STAI)
Measured: max. 3 weeks
Profile of Mood States (POMS)
Measured: max. 3 weeks
Short Form 36 Health Survey (SF-36)
Measured: max. 3 weeks
VAS for pain
Measured: max 3 weeks
Likert-Scales
Measured: max 3 weeks
FIQ
Measured: 6 month
FFBH, STAI, POMS, SF-36, VAS, Likert-Scales.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andreas Michalsen
- Sponsor type
- University, hospital or other
- Collaborators
- Dr.Heinz Horst Deichmann Foundation,Essen,Germany
- Responsible party
- Sponsor-investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charité Medical University Berlin Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389336
- Sponsor's protocol ID
- KAFA
- Acronym
- KAFA
- Status last verified
- May 2013
- First submitted
- 6 Jul 2011
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24073008
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kontrollierte Klinische Nicht-randomisierte Pilotstudie Zur Komplexen Āyurveda-Therapie Beim Fibromyalgiesyndrom im Vergleich Zur Konventionellen Standardbehandlung
- ClinicalTrials.gov ID
- NCT01389336
- Acronym / sponsor ID
- KAFA / KAFA
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia Syndrome, Fibromyalgia, Ayurveda, Traditional Indian Medicine, CAM, Pain, Chronic Widespread Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Andreas MichalsenUniversity, hospital or other
- Collaborators
- Dr.Heinz Horst Deichmann Foundation,Essen,Germany
- Study start
- Jul 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and Women with Fibromyalgia-Syndrome between 18 und 70 years of age
Key inclusion criteria (3 listed)
- informed consent
- age between 18 and 70 years
- FMS according to current guidelines
Key exclusion criteria (11 listed)
- change of pharmacological FMS treatment >= 6 weeks before inclusion
- pregnancy or breat feeding
- acute psychiatric condition
- severe acute somatic disease
- severechronic comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: max. 3 weeks
Change in FIQ after completion of IPD-treatment
8 secondary outcomes
Functional Hanover Questionnaire (FFBH)
Time frame: max. 3 weeks
State Trait Anxiety Inventory (STAI)
Time frame: max. 3 weeks
Profile of Mood States (POMS)
Time frame: max. 3 weeks
Short Form 36 Health Survey (SF-36)
Time frame: max. 3 weeks
VAS for pain
Time frame: max 3 weeks
Likert-Scales
Time frame: max 3 weeks
FIQ
Time frame: 6 month
FFBH, STAI, POMS, SF-36, VAS, Likert-Scales.
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
- Derived from this study: PubMed 24073008Kessler 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.
- Hospital WebsiteLink provided by the sponsor.
- University WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, Prof. Dr. principal investigator
Charité Medical University Berlin Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia Syndrome, run by Andreas Michalsen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (FIQ) (time frame: max. 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013.