LipedemaNCT07575555
The Effect of Lipedema on Knee Osteoarthritis
An observational study of Lipedema and Knee Osteoarthritis, run by Izmir Democracy University at 2 sites in Turkey (Türkiye).
Trial summary
This study will be one of the few to examine the effect of lipedema on knee osteoarthritis in a comparative manner with a control group within the same osteoarthritis context. Although the relationship between obesity and osteoarthritis has been extensively studied in the literature, the effect of specific adipose… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Lipedema, Knee Osteoarthritis, Knee Acute and Chronic Pain
- How many people
- 76 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 Jul 2026to 15 Aug 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study will include patients aged 30 and older who presented to the Physical Medicine and Rehabilitation Outpatient Clinic at Buca Seyfi Demirsoy Training and Research Hospital, Izmir Democracy University, between July 15, 2026, and July 15, 2027, and who were diagnosed with knee osteoarthritis based on clinical and radiological evaluations. Previously obtained knee X-rays will be retrospectively reviewed, and patients with osteoarthritis findings on X-rays according to the Kellgren-Lawrence grading system will be included in the study. The diagnosis of lipedema will be made by an experienced physical therapy and rehabilitation specialist based on a combined evaluation of clinical and ultrasonographic findings. The clinical diagnosis will be based on the Wold criteria: bilateral and symmetrical fat distribution in the lower extremities, foot sparing, tenderness and pain on palpation, a history of easy bruising, and fat accumulation resistant to diet and exercise.
Who may be able to join
- All participants (Group 1 + Group 2)
- Women aged 30-65
- With a clinical and radiological diagnosis of knee osteoarthritis
- Who agreed to participate in the study
- Group 1 (knee osteoarthritis with lipedema):
- Patients who meet the Wold criteria for a clinical diagnosis of lipedema
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- An increase in subcutaneous fat thickness confirmed by ultrasound
- Group 2 (knee osteoarthritis without lipedema):
- No diagnosis of lipedema
Who cannot join
- Inflammatory arthritis
- History of knee surgery
- Intra-articular injection within the past 6 months
- Acute trauma
- Systemic connective tissue disease
- Severe venous insufficiency or lymphedema
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- History of malignancy
- Use of gabapentinoids/SNRIs/SSRIs due to fibromyalgia or psychiatric illness
- Severe cognitive impairment or communication problems that would prevent participation in the study
- Pregnancy
- Participants who were informed about the study and refused to participate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Izmir Democracy University
Izmir, İzmir, 35570
Kadir Songür, +905054529231, kadir.93@gmail.com
- Recruiting
Izmir Democracy University
Izmir, İzmir, 35570
Kadir Songür, 05054529231, kadir.93@gmail.com
About this study
Official title: The Effect of Lipedema on Knee Osteoarthritis: A Cross-Sectional Analysis of Clinical Symptoms and Ultrasonographic Findings
This study will be one of the few to examine the effect of lipedema on knee osteoarthritis in a comparative manner with a control group within the same osteoarthritis context. Although the relationship between obesity and osteoarthritis has been extensively studied in the literature, the effect of specific adipose tissue pathologies, such as lipedema, on osteoarthritis has not been sufficiently investigated. This study aims to demonstrate the independent effect of lipedema on osteoarthritis, evaluate clinical and ultrasonographic parameters together, and contribute to early diagnosis and targeted rehabilitation strategies.
- Conditions
- Lipedema, Knee Osteoarthritis, Knee Acute and Chronic Pain, Knee, Knee Arthritis Osteoarthritis, Knee Arthropathy
- Keywords
- lipedema, knee osteoarthritis, knee joint, knee
- Medical subject headings
- Lipedema, Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Knee osteoarthritis with lipedema | |
| Group 2 | Knee osteoarthritis without lipedema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography-based measurements of femoral cartilage thickness
During femoral cartilage thickness measurements, participants will be positioned in the supine position, and the knee will be brought to maximum flexion for evaluation through the suprapatellar window. The probe will be positioned in the transverse plane, and measurements will be taken at the level of the medial and lateral femoral condyles and the intercondylar groove. For standardization, each measurement will be repeated three times, and the average will be recorded. Cartilage thickness will be defined as the distance between the hypoechoic cartilage layer and the subchondral bone surface. Lower values indicate that osteoarthritis has caused more structural damage.
Measured: Day 1
Secondary outcomes (11)
Western Ontario and McMaster Universities (WOMAC) score
The WOMAC Osteoarthritis Index questionnaire, consisting of 5 questions using a Likert scale, is provided in the attached case report form to assess pain, stiffness, and daily living functions. The WOMAC Osteoarthritis Index consists of 24 questions covering three subscales: pain (5 questions), stiffness (2 questions), and function (17 questions). The scoring system consists of the WOMAC pain score, WOMAC stiffness score, WOMAC function score, and WOMAC total score. A Turkish validity and reliability study has been conducted.
Measured: Day 1
Visual analog scale
Visual analog scale measures pain as it is subjectively perceived. It uses a 0-10 cm scale, the most commonly used tool for quantitatively determining pain intensity, with one end representing no pain and the other end representing the most severe pain possible. '0' indicates no pain, while '10' indicates the most severe pain. The individual is asked to select the numerical value that best represents their condition. This marked value is used as numerical data to determine the level of pain perception. A higher score indicates a higher level of pain.
Measured: Day 1
Joint Range of Motion measurement
Knee flexion and extension will be measured bilaterally using universal goniometry to assess patients' joint range of motion, and the angles will be recorded.
Measured: Day 1
Kellgren-Lawrence Classification
The Kellgren and Lawrence system is a widely used method that classifies the severity of knee osteoarthritis into five grades.
Measured: Day 1
Assessment of osteophytes via ultrasonography
During osteophyte assessment, participants will be positioned in the supine position with the knee flexed approximately 30 degrees; the probe will be placed along the medial and lateral joint lines in the longitudinal and transverse planes to examine bony projections. Osteophytes will be scored according to the Outcome Measures in Rheumatology knee osteoarthritis scale criteria as small (<2 mm - Grade 1), moderate (2-4 mm - Grade 2), and large (>4 mm - Grade 3).
Measured: Day 1
Assessment of synovial hypertrophy via ultrasonography
In the ultrasound assessment of synovial hypertrophy, the thickness of hypoechoic tissue in the suprapatellar region that does not shift upon probe compression will be measured, and values exceeding 2 mm will be recorded as synovial hypertrophy.
Measured: Day 1
Assessment of synovial effusion via ultrasonography
Ultrasonographic assessment of joint effusion will be performed at the suprapatellar recess level; participants will be positioned in the supine position with the knee in near-extension or slight flexion. During the longitudinal plane examination, anechoic fluid collections will be measured, and values of 4 mm or greater will be considered pathological synovial effusions.
Measured: Day 1
Assessment of meniscal protrusions via ultrasonography
During the ultrasound assessment of meniscus protrusion, the knee will be positioned with approximately 30 degrees of flexion, and the extent to which the meniscus tissue extends beyond the tibial margin will be evaluated in measurements taken in the longitudinal plane along the medial joint line; protrusions exceeding 3 mm will be considered pathological meniscus protrusions.
Measured: Day 1
Ultrasonography-based measurements of quadriceps muscle thickness
For ultrasonographic measurements of quadriceps muscle thickness, participants will be positioned in the supine position with the knee extended and the muscles fully relaxed; measurements taken in the transverse plane at the midpoint between the anterior superior iliac spine and the superior pole of the patella will assess the thicknesses of the rectus femoris and vastus intermedius muscles together.
Measured: Day 1
Ultrasonography-based measurements of quadriceps tendon thickness
Ultrasonographic measurements of the quadriceps tendon will be taken in the longitudinal plane immediately proximal to the superior pole of the patella while the knee is flexed to approximately 30 degrees, and the average of the measurements taken 5, 10, and 15 mm proximal to this point will be recorded
Measured: Day 1
Ultrasonography-based measurements of patellar tendon thickness
Ultrasonographic assessment of the patellar tendon is performed with the knee flexed to 30 degrees, in the longitudinal plane from the apex of the patella distally, and the anteroposterior thickness is measured approximately 5 mm distal to the apex.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start7 Jul 2026
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Songur, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575555
- Sponsor's protocol ID
- 2026/26
- Status last verified
- Jul 2026
- First submitted
- 3 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the data contain