The Effect of Lipedema on Knee Osteoarthritis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age30-65
SponsorIzmir Democracy University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 30-65

With a clinical and radiological diagnosis of knee osteoarthritis

Who agreed to participate in the study

Patients who meet the Wold criteria for a clinical diagnosis of lipedema

Disqualifiers

Inflammatory arthritis

History of knee surgery

Intra-articular injection within the past 6 months

Acute trauma

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

76 Participants
are grouped into 2 trial groups
Group A: Group 1
Group B: Group 2

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1

Secondary outcomes

1

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.

Time frame
Day 1
2

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.

Time frame
Day 1
3

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.

Time frame
Day 1
4

Kellgren-Lawrence Classification

The Kellgren and Lawrence system is a widely used method that classifies the severity of knee osteoarthritis into five grades.

Time frame
Day 1

Other outcomes

1

Ultrasonography-based measurements of pre-tibial and thigh subcutaneous thickness

The diagnosis of lipedema will be supported by ultrasonographic measurements of subcutaneous fat thickness in the thigh and pretibial regions. With the patient in the supine position and the lower extremities relaxed and in a neutral position, the probe is placed in the transverse plane (anterior surface of the tibia), at the midpoint between the tibial tuberosity and the medial malleolus, and on the thigh, at the midpoint along the midline between the iliac crest and the lower edge of the patella, and the total thickness of the skin and subcutaneous tissue will be measured in millimeters by applying minimal pressure. Each measurement will be taken three times, and the average will be calculated. In the literature, diagnostic threshold values have been established as a thickness measurement of \>11.7 mm in the pre-tibial region and \>17.9 mm in the thigh.

Time frame
Day 1

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