Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome

Conditions
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Fibromyalgia Syndrome

Intervention / Treatment
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* Other: major ozone autohemotherapy


Participation Criteria
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Eligibility Criteria
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Exclusion Criteria: has pregnancy, has primary romatological disease, has primary psychiatric disease <18, >60 years old patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: major ozone autohemotherapy|This treatment is based on treating 100 ml of the pa- tient's blood with 100 ml of O3 followed by reinfusion in the donor, in a fast procedure. Each patient received 10 sessions of autohemotherapy with O3 twice a week.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form Health Survey-36 | 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. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnare | 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. | 5 minutes |