Skip to content

Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome

Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05034770
Enrollment
45
Registered
2021-09-05
Start date
2017-01-01
Completion date
2022-01-11
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia Syndrome

Brief summary

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.

Interventions

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.

Sponsors

Emine Dundar Ahi, MD
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Exclusion criteria

* has pregnancy, * has primary romatological disease, * has primary psychiatric disease * \<18, \>60 years old patients

Design outcomes

Primary

MeasureTime frameDescription
Short Form Health Survey-3620 minutesthe 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.

Secondary

MeasureTime frameDescription
Fibromyalgia Impact Questionnare5 minutesThe 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.

Other

MeasureTime frameDescription
Visual Analog Scale (VAS)10 secondsThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026