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| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise + Major Ozone Autohemotherapy | Experimental |
| |
| Exercise + Placebo Ozone | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Major Ozone Autohemotherapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0) to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0), Week 6, and Month 3 |
| Change in Pittsburgh Sleep Quality Index (PSQI) Global Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emre Uzun, MD | Contact | +90 5548263922 | ftremreuzun@gmail.com | |
| Emre Uzun, MD | Contact | +90 5548263922 | dreemreuzunn@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sakarya Training and Research Hospital | Sakarya | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Placebo Ozone Autohemotherapy | Other | 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 | 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 |
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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. |
| Baseline (Day 0), Week 6, and Month 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 | Baseline (Day 0), Week 6, and Month 3 |
| 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 | Baseline (Day 0), Week 6, and Month 3 |
| Change in Pain Intensity (Visual Analog Scale, VAS) | Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain." | Baseline (Day 0), Week 6, and Month 3 |
| Change in Anxiety Symptoms (Hospital Anxiety and Depression Scale-Anxiety, HADS-A) | Anxiety symptoms will be assessed using the HADS-Anxiety subscale (HADS-A), scored 0-21; higher scores indicate greater anxiety severity | Baseline (Day 0), Week 6, and Month 3 |
| Change in Depressive Symptoms (Hospital Anxiety and Depression Scale-Depression, HADS-D) | Depressive symptoms will be assessed using the HADS-Depression subscale (HADS-D), scored 0-21; higher scores indicate greater depressive symptom severity | Baseline (Day 0), Week 6, and Month 3 |
| Change in Morning Fasting Serum Cortisol Level | Morning fasting venous blood samples will be collected between 08:00 and 09:00 to measure serum cortisol as an indicator of hypothalamic-pituitary-adrenal (HPA) axis activity | Baseline (Day 0), Week 6, and Month 3 |
| Change in Rectus Femoris Muscle Thickness (Ultrasound) | Rectus femoris muscle thickness will be measured by ultrasound at a standardized midpoint between the greater trochanter and the superior pole of the patella. The mean of three measurements will be recorded. | Baseline (Day 0), Week 6, and Month 3 |
| Change in Rectus Femoris Cross-Sectional Area (Ultrasound) | Rectus femoris cross-sectional area will be measured by ultrasound by tracing the muscle borders at the standardized measurement site | Baseline (Day 0), Week 6, and Month 3 |
| Change in Rectus Femoris Pennation Angle (Ultrasound) | Pennation angle will be measured on longitudinal ultrasound images as the angle between muscle fascicles and the deep aponeurosis of the rectus femoris. | Baseline (Day 0), Week 6, and Month 3 |
| Change in Rectus Femoris Fascicle Length (Ultrasound) | Fascicle length will be measured on longitudinal ultrasound images. When the entire fascicle is not visible, estimated fascicle length will be derived using muscle thickness and pennation angle. | Baseline (Day 0), Week 6, and Month 3 |
| Change in Rectus Femoris Echogenicity (Ultrasound Image Analysis) | Muscle echogenicity will be quantified from rectus femoris ultrasound images using 8-bit grayscale analysis (0-255) as an indicator of muscle quality and fatty infiltration. | Baseline (Day 0), Week 6, and Month 3 |
| Adverse Events | All adverse events occurring during the intervention period will be recorded and summarized by study group. | Throughout the study period (up to Month 3) |
| D009422 |
| Nervous System Diseases |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |