An Investigator-initiated Study Assessing the Effect of Intermittent Pneumatic Compression (IPC) on Symptoms and Quality of Life in Women With Lipo-lymphedema (Lipedema With Swelling)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Patient-Reported Symptoms of Lipo-Lymphedema
研究概览
简要总结
Lipedema is a connective tissue disorder that affects up to 10% of women. It is characterized by painful, swollen subcutaneous tissue and disproportionate fat accumulation (primarily in the lower limbs, however it can spread to the abdomen and arms). Patients are often not aware they are affected by this disease; rather, they think they are just overweight or obese.
Patients with lipedema often feel frustrated and uncomfortable as symptoms such as heaviness, pain, and easy bruising impact quality of life. Affected limbs can become so large and heavy that daily tasks such as walking, cleaning, or shopping become impossible.
There is currently no cure for lipedema, thus treatment focuses on symptom management and improved patient-reported outcomes. At present, the two main courses of treatment include non-surgical conservative treatment (e.g., Comprehensive Decongestive Therapy (CDT), diet, exercise, emotional/psychological/social support) and lymph-sparing liposuction performed by a surgeon trained in lipedema treatment. The primary goals for treatment include: reduction/elimination of inflammation, swelling, and pain; increase in lymphatic flow, which reduces/eliminates excessive fluid and swelling; overall management of the physical impact of lipedema; and quality of life improvements which can include emotional, psychological/mental, spiritual, and social enhancement in addition to physical management.
Intermittent Pneumatic Compression (IPC) devices are often used as home-therapy to treat secondary lymphedema or lipo-lymphedema (lipedema with swelling) and may be helpful in preventing the progression of lipedema. IPC use moves lymphatic fluid and supports the elimination of proteinaceous fluids, thus leading to improved patient-reported symptoms, decreased limb girth and volume, increased elasticity of tissues, and fewer episodes of infection.
The purpose of this study is to assess whether 3-4 weeks of IPC usage is associated with alleviation of symptoms and improvement in quality of life in women with lipo-lymphedema (lipedema with swelling).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age 18-70 years
- •Stage 2-3 (Schmeller Type 2-3) lipedema with secondary lymphedema
- •Willing and able to follow prescribed care for study period
- •Able to access (via self-pay, patient assistance, or insurance programs) prescribed care within 60 days of Screening visit
排除标准
- •BMI > 50
- •Heart failure (acute pulmonary edema, decompensated acute heart failure)
- •Pacemaker or implantable cardioverter defibrillator (ICD)
- •Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
- •Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene)
- •Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
- •Active cancer (cancer that is currently under treatment, but not yet in remission)
- •Poorly controlled kidney disease (glomerular filtration rate < 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome
- •Any circumstance where increased lymphatic or venous return is undesirable
- •Currently pregnant or trying to become pregnant
结局指标
主要结局
Patient-Reported Symptoms of Lipo-Lymphedema
时间窗: Changes between Screening and 3-4 weeks will be assessed
NRS Symptom Survey is a 6-item survey that asks patients to rate their perceptions of swelling, heaviness, pain, fatigue, tenderness, and tightness independently for each leg using a 10-point numerical rating scale where 0 represents none/not present and 10 is worst imaginable. All items are scored so that a low score is associated with fewer symptoms (defines a more favorable health state). The lowest and highest possible scores per leg are 0 and 60, respectively, with a combined total score between 0 and 120.
Patient-Reported Quality of Life
时间窗: Changes between Screening and 3-4 weeks will be assessed
RAND 36-Item Short Form Survey Instrument (SF-36) 1.0 is a global assessment of health impacts on quality of life that taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Patient-Reported Pain Interference
时间窗: Changes between Screening and 3-4 weeks will be assessed
PROMIS Item Bank v1.0 - Pain Interference - Short Form 6b is a 6 item survey that measures self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. All items are scored so that a low score is associated with less pain interference (a more favorable health state). In addition, each item is scored on a 1 to 5 range so that the lowest and highest possible scores are 6 and 30, respectively.
Change in Circumferential Measurements Over Time
时间窗: Changes between Screening and 3-4 weeks will be assessed
Tape measurements along both legs
Patient-Reported Pain
时间窗: Changes between Screening and 3-4 weeks will be assessed
Wong Baker Faces Scale is a self-assessment tool that is easily understood by patients, so they are able to choose the face that best illustrates the physical pain they are experiencing associated with their lipo-lymphedema. Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain.
次要结局
- Change in Bioimpedance Measurements Over Time(Changes between Screening and 3-4 weeks will be assessed)
- Patient-Reported Mobility(Changes between Screening and 3-4 weeks will be assessed)
研究者
Thomas Wright, MD
MD, FACPh, FACP, RVT
Tactile Medical