An interventional study of Ozone therapy in Lipedema, Pain and Activities of Daily Living, sponsored by Ankara Etlik City Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Ankara Etlik City Hospital · Not applicable, Interventional, and Treatment
Lipedema is a disease characterized by enlargement of the subcutaneous tissue and is observed only in the female population. Recently, the inflammatory cascade has been suggested to be the initiator of lipoedema and to play a role in its progression. The presence of pain in the involved areas is the most important symptom affecting the patient's QoL.
In the literature, ozone therapy is used both locally and systemically in many diseases in which inflammation is involved in the etiopathogenesis. There are many studies on plantar fasciitis, lateral epicondylitis, rheumatoid arthritis, osteoarthritis, etc. In addition to its anti-inflammatory properties, ozone therapy, which has analgesic and aseptic properties, has not been found in the literature in patients with lipedema.
The aim of this study was to investigate the effect of ozone therapy on pain symptoms and subcutaneous tissue thickness in patients with lipedema and to compare local and systemic ozone applications in these patients.
The study, which is planned as a prospective randomized intervention, will include 50 female patients aged 18-65 years with a diagnosis of lipedema by a physician who applied to Etlik City Hospital Physical Medicine and Rehabilitation clinic and had pain >4 evaluated by VAS.
Since there is no study evaluating ozone therapy in lipedema in the literature, the sample size calculated with G*Power 3.0.10a based on another ozone therapy study was found to be 15 patients each. Considering the possibility of dropout from the study, the sample size was determined as 50 volunteers in total.
After clinical diagnosis, pain with visual analog scale (VAS) and pain detect pain questionnaire will be applied to evaluate neuropathic pain. In patients with lipedema, measurements will be made by a physical medicine and rehabilitation physician with 10 years of experience in musculoskeletal ultrasonography from the areas previously defined ultrasonographically in the literature (Midpoint between the superior anterior iliac crest and the inferior patellar border, medial tubercle of the femur, midpoint between the tibial tuberosity and the medial malleolus, midpoint between the lateral malleolus and the fibular head, medial supramalleolar) with the ultrasonography device available in the clinic.Patients' age, comorbidities, medications and routine laboratory parameters such as neutrophil/lymphocyte ratio, platelet distribution width, mean platelet volume, sedimentation, CRP, hemogram values will be recorded. VAS, pain detection and ultrasonographic measurements will be repeated at the 1st and 3rd month after the end of the application.
After the patients were randomized into three groups, the first group will receive local ozone, the second group will receive systemic ozone, and the third group will receive both local and systemic ozone. Local ozone will be injected into the painful points of the patient at the level of the medial tubercle of the femur, 10 gamma 10 cc ozone injection will be made radiationally from 5 regions with 1 cm intervals under the guidance of USG (3 sessions). Systemic ozone application will be given in 3 sessions of 40 gamma each.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's enrollment of 45 is above the median of 35 across 42 interventional studies indexed under Lipedema.
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Exclusion Criteria:
1 session of 40 gamma per week, a total of three weeks of major ozone therapy will be applied
Other: Ozone therapy
10 gamma local ozone injection per week, a total of three weeks will be performed 5 times with 1 cm intervals to the painful points of the patient.
Other: Ozone therapy
1 session of 40 gamma per week, a total of three weeks of major ozone therapy will be applied and also 10 gamma local ozone injection per week, a total of three weeks will be performed 5 times with 1 cm intervals to the painful points of the patient.
Other: Ozone therapy
As detailed in the research arms, major ozone application and local ozone application will be performed.
Visual analog scale
A visual analog scale will be used to assess pain intensity. In this scale, which is scored between 1-10, 0 indicates the best condition and 10 indicates the most severe pain.
Time frame: before application, at 1st and 3rd month
painDETECT Questionnaire
painDETECT Questionnaire will be performed for neuropathic pain. A total score of 19 or more is indicative of likely neuropathic pain.
Time frame: before application, at 1st and 3rd month
Subcutaneous ultrasonographic measurement
Subcutaneous ultrasonographic measurement will be performed. The measurement of subcutaneous adipose tissue will be recorded in mm.
Time frame: before application, at 1st and 3rd month
Plan to share: No
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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