Effect of Systemic and Local Ozone Therapy in Lipedema

NCT06954870 | Completed

• 1 other identifier: 2025/16
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lipedema; Pain; Activities of Daily Living; Musculoskeletal Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  before application, at 1st and 3rd month

Secondary Outcomes (2)

• painDETECT Questionnaire

  before application, at 1st and 3rd month

• Subcutaneous ultrasonographic measurement

  before application, at 1st and 3rd month

Study Arms (3)

Systemic ozone therapy

EXPERIMENTAL

1 session of 40 gamma per week, a total of three weeks of major ozone therapy will be applied

Other: Ozone therapy

Local ozone therapy

EXPERIMENTAL

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

Both systemic and local ozone therapy

EXPERIMENTAL

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

Interventions

Ozone therapy OTHER

As detailed in the research arms, major ozone application and local ozone application will be performed.

Both systemic and local ozone therapy; Local ozone therapy; Systemic ozone therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Lipedema is a disease that almost always affects women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To have been diagnosed with clinical lipedema.
• Pain assessed by VAS of 5 or more
• Being a woman
• Being between 18-65 years old

You may not qualify if:

• Presence of venous insufficiency leading to subcutaneous changes
• Having diseases that may cause edema
• Use of painkillers (NSAIDs/Opioids) up to 1 week before the injection
• Open wound or infection at the site of infection
• Bleeding disorders or use of anticoagulant, antiplatelet drugs uncontrolled systemic disease
• G6PD deficiency
• Cases where the pain cannot be explained by lipoedematous tissue

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation

Ankara, 06200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lipedema; Pain

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Başak Mansız Kaplan, MD,AssocProf

  Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr. Başak Mansız Kaplan Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation, Head of the Orthopedic Rehabilitation Clinic

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: May 2, 2025
• Study Start: March 25, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 31, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)