Effects of Major Ozone Autohemotherapy on Sarcopenia Parameters and Clinical Features in Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Fibromyalgia Impact Questionnaire (FIQ) Total Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
- •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
结局指标
主要结局
Change in Fibromyalgia Impact Questionnaire (FIQ) Total Score
时间窗: Baseline (Day 0) to Month 3
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.
次要结局
- Change in Fatigue Severity Scale (FSS) Score(Baseline (Day 0), Week 6, and Month 3)
- Change in Pittsburgh Sleep Quality Index (PSQI) Global Score(Baseline (Day 0), Week 6, and Month 3)
- Change in Health-Related Quality of Life (SF-12 PCS)(Baseline (Day 0), Week 6, and Month 3)
- Change in Health-Related Quality of Life (SF-12 MCS)(Baseline (Day 0), Week 6, and Month 3)
- Change in Pain Intensity (Visual Analog Scale, VAS)(Baseline (Day 0), Week 6, and Month 3)
- Change in Anxiety Symptoms (Hospital Anxiety and Depression Scale-Anxiety, HADS-A)(Baseline (Day 0), Week 6, and Month 3)
- Change in Depressive Symptoms (Hospital Anxiety and Depression Scale-Depression, HADS-D)(Baseline (Day 0), Week 6, and Month 3)
- Change in Morning Fasting Serum Cortisol Level(Baseline (Day 0), Week 6, and Month 3)
- Change in Rectus Femoris Muscle Thickness (Ultrasound)(Baseline (Day 0), Week 6, and Month 3)
- Change in Rectus Femoris Cross-Sectional Area (Ultrasound)(Baseline (Day 0), Week 6, and Month 3)
- Change in Rectus Femoris Pennation Angle (Ultrasound)(Baseline (Day 0), Week 6, and Month 3)
- Change in Rectus Femoris Fascicle Length (Ultrasound)(Baseline (Day 0), Week 6, and Month 3)
- Change in Rectus Femoris Echogenicity (Ultrasound Image Analysis)(Baseline (Day 0), Week 6, and Month 3)
- Adverse Events(Throughout the study period (up to Month 3))
研究者
Alİ Eman, MD
Professor
Sakarya University