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The Effect of Lipedema on Knee Osteoarthritis

2026年7月7日 更新者:Kadir Songur、Izmir Democracy University

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.

研究概览

研究类型

观察性的

注册 (估计的)

76

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Kadir Songür, Assoc. Prof.
  • 电话号码:+905054529231
  • 邮箱:kadir.93@gmail.com

学习地点

    • İzmir
      • Izmir、İzmir、土耳其(türkiye)、35570
        • 招聘中
        • Izmir Democracy University
        • 接触:
      • Izmir、İzmir、土耳其(türkiye)、35570
        • 尚未招聘
        • Izmir Democracy University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

Inclusion Criteria:

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
  • An increase in subcutaneous fat thickness confirmed by ultrasound

Group 2 (knee osteoarthritis without lipedema):

  • No diagnosis of lipedema
  • Exclusion of lymphedema and venous diseases

Exclusion Criteria:

  • 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
  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Group 1
Knee osteoarthritis with lipedema
Group 2
Knee osteoarthritis without lipedema

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Ultrasonography-based measurements of femoral cartilage thickness
大体时间:Day 1
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.
Day 1

次要结果测量

结果测量
措施说明
大体时间
西安大略大学和麦克马斯特大学(WOMAC)评分
大体时间:第一天
WOMAC骨关节炎指数问卷包含5个采用李克特量表的问题,附于病例报告表中,用于评估疼痛、僵硬和日常生活功能。 WOMAC骨关节炎指数包含24个问题,涵盖三个子量表:疼痛(5个问题)、僵硬(2个问题)和功能(17个问题)。 评分系统包括WOMAC疼痛评分、WOMAC僵硬评分、WOMAC功能评分和WOMAC总分。 已进行土耳其语的有效性和可靠性研究。
第一天
视觉模拟评分法
大体时间:第 1 天
视觉模拟评分量表用于测量主观感知的疼痛。 它采用0-10厘米的量表,这是最常用于定量确定疼痛强度的工具,一端代表无疼痛,另一端代表可能的最严重疼痛。 '0'表示无疼痛,而'10'表示最严重的疼痛。 要求个体选择最能代表其状况的数值。 此标记值作为数值数据用于确定疼痛感知水平。 分数越高表示疼痛程度越高。
第 1 天
关节活动度测量
大体时间:第 1 天
将使用通用测角仪双侧测量膝关节屈伸活动度以评估患者的关节活动范围,并记录角度。
第 1 天
Kellgren-Lawrence分级
大体时间:第 1 天
Kellgren 和 Lawrence 系统是一种广泛使用的方法,将膝关节骨关节炎的严重程度分为五个等级。
第 1 天
Assessment of osteophytes via ultrasonography
大体时间:Day 1
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).
Day 1
Assessment of synovial hypertrophy via ultrasonography
大体时间:Day 1
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.
Day 1
Assessment of synovial effusion via ultrasonography
大体时间:Day 1
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.
Day 1
Assessment of meniscal protrusions via ultrasonography
大体时间:Day 1
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.
Day 1
Ultrasonography-based measurements of quadriceps muscle thickness
大体时间:Day 1
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.
Day 1
Ultrasonography-based measurements of quadriceps tendon thickness
大体时间:Day 1
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
Day 1
Ultrasonography-based measurements of patellar tendon thickness
大体时间:Day 1
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.
Day 1

其他结果措施

结果测量
措施说明
大体时间
Ultrasonography-based measurements of pre-tibial and thigh subcutaneous thickness
大体时间:Day 1
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.
Day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月7日

初级完成 (估计的)

2027年7月15日

研究完成 (估计的)

2027年8月15日

研究注册日期

首次提交

2026年5月3日

首先提交符合 QC 标准的

2026年5月3日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月7日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data (IPD) will not be shared because the data contain

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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