- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05034770
Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome
August 4, 2022 updated by: Emine Dundar Ahi, MD
Patients who were admitted to the Physical Medicine and Rehabilitation (PMR) outpatient clinic of our hospital between January 2017 and December 2020 and were treated with Major ozone autohemotherapy with a diagnosis of Fibromyalgia syndrome will include to the study.
Visual anolog scale (VAS), Fibromyalgia Impact Questionnare (FIQ) and Short Form Health Survey-36 (SF-36) scores of the patients before and after treatment were recorded.
Statistical analysis of these outcome scores will be made.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kocaeli, Turkey
- Private Medar Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- 18-60 years ranged, male and female patients
- diagnosed fibromyalgia syndrome witc ACR 1990,2010 criterias,
- volunteers that gave consent,
- treated with major ozone autohemotherapy (10 sessions)
Description
Exclusion Criteria:
- has pregnancy,
- has primary romatological disease,
- has primary psychiatric disease
- <18, >60 years old patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form Health Survey-36
Time Frame: 20 minutes
|
the 36-item Short Form Health Survey (SF-36) is a measure of health-related quality-of-life.
It allows assessment across eight health domains: physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH).
The scores of these eight domains can also be summated in two major categories: physical composite score (PCS) and mental composite score (MCS) to reflect the overall physical and mental health, respectively.
Scores of 100 for PF, RP, BP, SF, and RE domains and scores of 50 in the remaining three domains, GH, VT, and MH, indicate an absence of problems in those areas.
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20 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibromyalgia Impact Questionnare
Time Frame: 5 minutes
|
The Fibromyalgia Impact Questionnare (FIQ) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes.
It has been designed to measure the components of health status that are believed to be most affected by FM.
FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person.
Each of the 10 items has a maximum possible score of 10.
Thus the maximum possible score is 100.
The average FM patient scores about 50, severely afflicted patients are usually 70 plus.
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5 minutes
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: 10 seconds
|
The Visual Analog Scale (VAS) is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling.
FM patients mark the point on the line that best corresponds to their symptom severity.
To this end, they are instructed to put a cross on the straight line at the point that most accurately expresses their degree of agreement.
When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100.
If documented in paper form, the scores can then be simply transferred to a 100-value scale using a millimeter tape measure.
The division into hundredths is considered sufficiently sensitive.
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10 seconds
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
January 10, 2022
Study Completion (Actual)
January 11, 2022
Study Registration Dates
First Submitted
May 21, 2021
First Submitted That Met QC Criteria
September 2, 2021
First Posted (Actual)
September 5, 2021
Study Record Updates
Last Update Posted (Actual)
August 5, 2022
Last Update Submitted That Met QC Criteria
August 4, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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