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OpenTrials
Completed

NCT Number: NCT05034770

Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Private Medar Hospital

Kocaeli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Emine Dundar Ahi, MD

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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