Impact of Major Ozone Autohemotherapy on Sarcopenia Parameters in Fibromyalgia
Key facts
- Who runs it
- Sakarya University
- Where
- Sakarya, TürkiyeSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 60 people, planned
- Started
- Aug 2026
- Expected to end
- Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Major Ozone Autohemotherapy
- Placebo Ozone Autohemotherapy
- Exercise Therapy
- Record updated
- 2 July 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Female patients aged 18-65 years
- Diagnosis of fibromyalgia syndrome according to the 2016 ACR criteria:
- Symptoms present at a similar level for at least 3 months
- Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Scale (SSS) ≥ 5
- WPI 4-6 and SSS ≥ 9
- Not currently receiving medical treatment for fibromyalgia (except NSAIDs)
Who cannot take part
- Current or previous pharmacological treatment specifically for fibromyalgia
- History of active or previous malignancy
- History of systemic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, dermatomyositis, familial Mediterranean fever)
- Endocrine disorders (e.g., hypothyroidism, Cushing's syndrome, adrenal insufficiency)
- Chronic renal failure
- Chronic liver failure
- Chronic obstructive pulmonary disease (COPD)
- Known severe cardiovascular disease
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Pregnancy or breastfeeding
- Anemia
- Body mass index (BMI) > 30 kg/m²
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Türkiye
- Sakarya Training and Research HospitalSakarya, TürkiyeContact: Emre Uzun, MDNo longer taking part
About the trial
What the trial wants to find out
Fibromyalgia syndrome (FMS) is a chronic and heterogeneous disorder characterized primarily by widespread pain, accompanied by sleep disturbances, fatigue, depressive symptoms, and cognitive dysfunction. Although multiple therapeutic options are available, no curative treatment currently exists. Previous studies have demonstrated increased oxidative stress, dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, and a predisposition to sarcopenia in patients with FMS.
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Ozone therapy has increasingly been used in chronic diseases due to its regulatory effects on oxidative stress. Although ozone is inherently an oxidative molecule, when administered at therapeutic doses it may induce antioxidant responses at the cellular level and exert anti-inflammatory effects by modulating inflammatory mediators. However, limited studies have evaluated the efficacy and underlying mechanisms of major ozone autohemotherapy (MOA) in FMS.
This controlled, prospective, single-blind study aims to investigate the effects of major ozone autohemotherapy on clinical parameters of FMS, as well as its impact on HPA axis function and sarcopenia-related parameters. A total of 60 patients with FMS will be enrolled and randomized into two groups: (1) exercise therapy alone and (2) exercise therapy plus major ozone autohemotherapy. MOA will be administered twice weekly for a total of 10 sessions at a dose of 20-40 μg/mL.
Participants will be evaluated at baseline, at week 6, and at 3 months. Outcome measures will include Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Fatigue Severity Scale (FSS), Pittsburgh Sleep Quality Index (PSQI), Short Form-12 (SF-12), and Hospital Anxiety and Depression Scale (HADS). Morning fasting serum cortisol levels will be measured to assess HPA axis function. Sarcopenia assessment will include handgrip strength measured by Jamar dynamometer, and ultrasonographic evaluation of muscle mass, muscle thickness, pennation angle, fascicle length, echogenicity, and cross-sectional area. Physical performance will be assessed using the Short Physical Performance Battery (SPPB).
Unlike previous studies, this trial includes a 3-month follow-up evaluation after completion of ozone therapy to assess longer-term effects. By incorporating objective sarcopenia and endocrine assessments alongside validated clinical scales, the study aims to provide comprehensive evidence regarding the role of major ozone autohemotherapy in FMS management. This will be the first study to specifically evaluate the effects of major ozone autohemotherapy on sarcopenia parameters in patients with FMS.
The 2 groups in the trial
- Exercise + Major Ozone AutohemotherapyTreatment being tested
Treatment: Major Ozone Autohemotherapy and Exercise Therapy
- Exercise + Placebo OzonePlacebo, for comparison
Treatment: Placebo Ozone Autohemotherapy and Exercise Therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Major Ozone Autohemotherapy on Sarcopenia Parameters and Clinical Features in Fibromyalgia
- Fit questions
- Built from NCT07680621, who can take part
- Record updated
- 2 July 2026