Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome

Sponsor
Emine Dundar Ahi, MD (Other)
Overall Status
Completed
CT.gov ID
NCT05034770
Collaborator
(none)
45
1
60.3
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: major ozone autohemotherapy

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jan 10, 2022
Actual Study Completion Date :
Jan 11, 2022

Outcome Measures

Primary Outcome Measures

  1. Short Form Health Survey-36 [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 Outcome Measures

  1. Fibromyalgia Impact Questionnare [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 Outcome Measures

  1. Visual Analog Scale (VAS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Exclusion Criteria:
  • has pregnancy,

  • has primary romatological disease,

  • has primary psychiatric disease

  • <18, >60 years old patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Private Medar Hospital Kocaeli Turkey

Sponsors and Collaborators

  • Emine Dundar Ahi, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emine Dundar Ahi, MD, Principal Investigator, Kocaeli University
ClinicalTrials.gov Identifier:
NCT05034770
Other Study ID Numbers:
  • 2020-161
First Posted:
Sep 5, 2021
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022