Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome

NCT05034770 | Completed

• 1 other identifier: 2020-161
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fibromyalgia Impact Questionnare

  5 minutes

Other Outcomes (1)

• Visual Analog Scale (VAS)

  10 seconds

Interventions

major ozone autohemotherapy OTHER

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Emine Dundar Ahi, MD: lead

Study Sites (1)

Private Medar Hospital

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: September 5, 2021
• Study Start: January 1, 2017
• Primary Completion: January 10, 2022
• Study Completion: January 11, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)