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Impact of Major Ozone Autohemotherapy on Sarcopenia Parameters in Fibromyalgia

ConditionFibromyalgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSakarya University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18-65 years

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Major Ozone Autohemotherapy

    Other intervention

    Major ozone autohemotherapy will be administered twice weekly for a total of 10 sessions. In each session, 100 mL of venous blood will be withdrawn into a sterile citrate-containing glass bottle, mixed with 100 mL of an ozone-oxygen gas mixture at a concentration of 20-40 μg/mL, and reinfused intravenously over approximately 7-10 minutes. The procedure will be performed by certified physicians according to the Madrid Declaration on Ozone Therapy guidelines.

  • Placebo Ozone Autohemotherapy

    Other intervention

    The placebo procedure will be identical to the active major ozone autohemotherapy protocol; however, a non-therapeutic ozone concentration (0.1 μg/mL) will be used. Blood withdrawal, mixing, and reinfusion procedures will be performed in the same manner to maintain blinding.

  • Exercise Therapy

    Other intervention

    Participants will undergo a supervised exercise program twice weekly for 3 months. Each 60-minute session will include warm-up walking, aerobic exercise at 60-65% of maximum heart rate, strengthening exercises targeting major muscle groups, and stretching exercises. Exercise intensity will be gradually progressed if tolerated without symptom exacerbation

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Exercise + Major Ozone AutohemotherapyExperimental treatment 2 interventions
Group B: Exercise + Placebo OzonePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in Fibromyalgia Impact Questionnaire (FIQ) Total Score

The Fibromyalgia Impact Questionnaire (FIQ) will be used to assess overall disease impact and functional status. The total score ranges from 0 to 100, with higher scores indicating greater disease impact/severity. The primary endpoint is the between-group difference in change in FIQ total score from baseline to Month 3.

Time frame
Baseline (Day 0) to Month 3

Secondary outcomes

1

Change in Fatigue Severity Scale (FSS) Score

Fatigue will be assessed using the Fatigue Severity Scale (FSS). The score is calculated as the mean of 9 items rated 1-7; higher scores indicate more severe fatigue.

Time frame
Baseline (Day 0), Week 6, and Month 3
2

Change in Pittsburgh Sleep Quality Index (PSQI) Global Score

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) global score (range 0-21). Higher scores indicate worse sleep quality; scores \>5 suggest poor sleep quality.

Time frame
Baseline (Day 0), Week 6, and Month 3
3

Change in Health-Related Quality of Life (SF-12 PCS)

Health-related quality of life will be assessed using the Short Form-12 (SF-12), generating Physical Component Summary (PCS) scores. Higher scores indicate better health status

Time frame
Baseline (Day 0), Week 6, and Month 3
4

Change in Health-Related Quality of Life (SF-12 MCS)

Health-related quality of life will be assessed using the Short Form-12 (SF-12), generating Mental Component Summary (MCS) scores. Higher scores indicate better health status

Time frame
Baseline (Day 0), Week 6, and Month 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sakarya University

Lead sponsor

The Scientific and Technological Research Council of Turkey

Collaborator

Source ClinicalTrials.gov

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