FibromyalgiaNCT07680621
Impact of Major Ozone Autohemotherapy on Sarcopenia Parameters in Fibromyalgia
A study testing Major Ozone Autohemotherapy and Exercise Therapy in people with Fibromyalgia, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Major Ozone Autohemotherapy and Exercise Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sakarya Training and Research Hospital
Sakarya
Emre Uzun, MD, +90 5548263922, ftremreuzun@gmail.com
About this study
Official title: Effects of Major Ozone Autohemotherapy on Sarcopenia Parameters and Clinical Features in Fibromyalgia
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.
Read more
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.
- Conditions
- Fibromyalgia
- Being tested
- Major Ozone Autohemotherapy, Placebo Ozone Autohemotherapy, Exercise Therapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major Ozone AutohemotherapyOther
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 AutohemotherapyOther
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 TherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise + Major Ozone Autohemotherapy | Experimental | Not described Receives: Other: Major Ozone Autohemotherapy; Other: Exercise Therapy |
| Exercise + Placebo Ozone | Placebo comparator | Not described Receives: Other: Placebo Ozone Autohemotherapy; Other: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0) to Month 3
Secondary outcomes (14)
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.
Measured: Baseline (Day 0), Week 6, and Month 3
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.
Measured: 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
Measured: 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
Measured: 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."
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Throughout the study period (up to Month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Alİ Eman, MD, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680621
- Sponsor's protocol ID
- UZUN-FTR-EU-54
- Status last verified
- Jul 2026
- First submitted
- 30 Apr 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Major Ozone Autohemotherapy on Sarcopenia Parameters and Clinical Features in Fibromyalgia
- ClinicalTrials.gov ID
- NCT07680621
- Acronym / sponsor ID
- UZUN-FTR-EU-54
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Aug 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + Major Ozone Autohemotherapy | Experimental | Other: Major Ozone Autohemotherapy, Other: Exercise Therapy |
| Exercise + Placebo Ozone | Placebo comparator | Other: Placebo Ozone Autohemotherapy, Other: Exercise Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Major Ozone AutohemotherapyMajor 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. | Other | Exercise + Major Ozone Autohemotherapy |
| Placebo Ozone AutohemotherapyThe 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. | Other | Exercise + Placebo Ozone |
| Exercise TherapyParticipants 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 | Other | Exercise + Major Ozone Autohemotherapy, Exercise + Placebo Ozone |
Primary outcome
Change in Fibromyalgia Impact Questionnaire (FIQ) Total Score
Time frame: 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.
14 secondary outcomes
Change in Fatigue Severity Scale (FSS) Score
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Health-Related Quality of Life (SF-12 PCS)
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Health-Related Quality of Life (SF-12 MCS)
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Pain Intensity (Visual Analog Scale, VAS)
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Anxiety Symptoms (Hospital Anxiety and Depression Scale-Anxiety, HADS-A)
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Depressive Symptoms (Hospital Anxiety and Depression Scale-Depression, HADS-D)
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Morning Fasting Serum Cortisol Level
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Rectus Femoris Muscle Thickness (Ultrasound)
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Rectus Femoris Cross-Sectional Area (Ultrasound)
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Rectus Femoris Pennation Angle (Ultrasound)
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Rectus Femoris Fascicle Length (Ultrasound)
Time frame: Baseline (Day 0), Week 6, and Month 3
Change in Rectus Femoris Echogenicity (Ultrasound Image Analysis)
Time frame: Baseline (Day 0), Week 6, and Month 3
Adverse Events
Time frame: Throughout the study period (up to Month 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Major Ozone Autohemotherapy and Exercise Therapy in people with Fibromyalgia, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emre Uzun, MD (+90 5548263922, ftremreuzun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fibromyalgia Impact Questionnaire (FIQ) Total Score (time frame: Baseline (Day 0) to Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.