Impact of Major Ozone Autohemotherapy on Sarcopenia Parameters in Fibromyalgia

Starting soon · Not applicable · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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. 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.

Key facts

Study ID: NCT07680621
Run by: Sakarya University
People needed: 60
Starts: 2026-08-01
Expected to finish: 2027-03-01
Last updated by the study team: 2026-07-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

Current or previous pharmacological treatment specifically for fibromyalgia
Pregnancy or breastfeeding
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)
Anemia
Chronic renal failure
Chronic liver failure
Chronic obstructive pulmonary disease (COPD)
Known severe cardiovascular disease
Body mass index (BMI) > 30 kg/m²
Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Where it is running

Sakarya Training and Research Hospital — Sakarya, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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