Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome

Fibromyalgia Syndrome Clinical Trial

Official title:

Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034770
• Other study ID #: 2020-161
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 11, 2022

Study information

• Verified date: August 2022
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 11, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Exclusion Criteria:

• has pregnancy,

• has primary romatological disease,

• has primary psychiatric disease

• <18, >60 years old patients

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Turkey	Private Medar Hospital	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Emine Dundar Ahi, MD

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analog Scale (VAS)	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 suf?ciently sensitive.	10 seconds
Primary	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	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