Effects of Intermittent Pneumatic Compression Therapy on Tissue Volume, Pain, and Quality of Life in Women Living With Lipedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Volumetric measurements by caliper
研究概览
简要总结
Lipedema is an inflammatory and painful disease of subcutaneous adipose tissue (SAT) in women that is associated with vein disease and lymphedema. There is controversy on whether there is edema in lipedema. This study seeks to determine: 1. Is there is edema in lipedema? 2. Can edema, lipedema subcutaneous adipose tissue (SAT), symptoms, and quality of life be improved by an advanced intermittent pneumatic compression device (IPCD)?
During the course of the study subjects will be seen three times in the clinic for assessment and measurements. All subjects will be provided a compression legging at the first clinic visit. Half of the subjects (the treatment group) will be provided and use an advanced intermittent pneumatic compression device with pants-type appliance that applies dynamic compression therapy to the abdomen, hips, buttocks, legs and feet, starting at the second visit, for 30 days at home, along with daytime use of the compression legging. The other half (the control group) will use the compression leggings only. At the third visit, final measurements will be obtained. The measurements in the study include volume measurements using tape measure and a scanner; body composition measurements (bioimpedance); ultrasound and biopsy of the skin; timed walking and gait measurements; and questionnaires about pain and quality of life. Deidentified (without names) patient medical records will be examined for information on vein disease, body mass index, weight, age, and stage of lipedema (any stage or type). After the third visit, results will be analyzed.
详细描述
Introduction Lipedema is a disease of loose connective (adipose) tissue that has no known cause or cure. One of the main features is an increased amount of abnormal fibrotic subcutaneous adipose tissue (SAT) deposited in the legs, pelvis, abdomen and/or arms of women.
Management options for lipedema focus on improving lymphatic flow, controlling edema (swelling), reducing pain or discomfort, and deep tissue therapy to try and reduce fibrosis. Intermittent pneumatic compression devices (IPCDs) are externally applied "pumps," that reduce leg swelling and improve pain and quality of life for patients with lipedema.
No study has demonstrated an improvement in fat volume (relative to total leg volume), fascia quality, and fibrosis of the leg after the use of IPCDs.
The goal of this study is to improve our understanding of lipedema tissue and how use of the IPCD, Lympha Press® Optimal Plus with Lympha Pants™ garments, may improve tissue volume, fluid, quality, quality of life, and pain levels in women with lipedema.
This is a randomized, controlled study of 50 women with lipedema with 25 women in the Treatment group and 25 women in the Control group. Women with lipedema will be recruited from women with lipedema who have had their vein disease treated. Women in this part of the study will therefore have only lipedema without active treatable vein disease. Both legs of all enrolled women will be studied for a total of 100 legs evaluated. All participants in the Treatment group will be supplied the Lympha Press Optimal Plus IPCD and the Lympha Pants™ garment to treat the lower body including the abdomen, pelvis, and buttocks (trunk) and the lower extremities. All participants in the study (Treatment and Controls) will receive compression leggings, and will be instructed to wear them daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Females age 18 - 70 years.
- •Diagnosis of Stage 2-3 Type II-III lipedema
- •Patients with an IPCD must agree to wash off the pump over 30 days prior to the study starting.
- •Must have pain score with or without pressure in any lipedema area of 3 or more out of 11-point Likert visual analogue scale.
- •Able to maintain their current diet and exercise regimen for the 60-day study.
- •Must be ambulatory.
- •Must be willing to wear compression during the study. Compression is provided at no cost as part of the study.
- •Consistent eating plan with weight stability (within 10 lbs or usual weight fluctuation per the patient) over three months.
- •Must agree to not change their diet and exercise during the study.
排除标准
- •Inability to understand the purpose of the study and complete consent.
- •Bed bound, preventing assessment of activities of daily living like the rest of the population we are studying.
- •Contraindications to IPCD use:
- •serious arterial insufficiency measured as a monophasic pulse wave by Doppler
- •edema due to decompensated congestive heart failure by history - all patients with a diagnosis of CHF will be excluded for purpose of the study
- •active phlebitis by physical exam
- •active deep vein thrombosis by history
- •localized wound infection by physical exam
- •cellulitis by physical exam
- •Lymphedema with minimal to no lipedema.
- •Positive Stemmer sign on the feet.
- •Weight > 375 lbs. (170 kg) due to weight restriction on bioimpedance device.
- •Undergoing surgery during the time of the study.
- •Weight loss surgery within the past 18 months.
- •Use of diuretic medication.
- •Participation in another research study at the time of the study.
- •Use of immunosuppressant medications including Gleevec, diosmin, methotrexate, corticosteroids, Plaquenil or other. If they are on these medications, they must wean off for one month or not participate in this study.
- •Medical illness deemed significant by the PI.
- •Waist to hip ratio > 0.
- •Undergoing manual therapy of any kind including massage, physical therapy, occupational therapy, manual lymphatic drainage therapy, instrument assisted soft tissue therapy or other deep tissue therapy. Subjects must agree to stop all manual therapy for one month prior to participation in this study.
结局指标
主要结局
Volumetric measurements by caliper
时间窗: 30 days
caliper measurements under the umbilicus, on the anterior thigh and medial thighs previously measured in women with lipedema
Volumetric measurement
时间窗: 30 days
Volumetric measurement of lower torso and legs using a validated handheld three dimensional scanning device (Lymphatech Company)
Tissue/fluid assessment by bioimpedance analysis
时间窗: 30 days
Leg and trunk fluid volume measured by bioimpedance analyses
Pain measured using visual analog scale
时间窗: 30 days
Leg pain measured by Visual Analog Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Lower extremity functional scale (LEFS)
时间窗: 30 days
he Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The scale for each question is 0 - 4, with 0 = extreme difficulty and 4 = no difficulty. The lower the score the greater the disability. * The minimal detectable change is 9 scale points. * The minimal clinically important difference is 9 scale points. * % of maximal function = (LEFS score) / 80 \* 10
ultrasound assessment of adipose tissue deposits
时间窗: 30 days
ultrasound of lower extremities and hips to assess fascia, echogenicity and depth. The integrity and quality of SAT superficial and deep fascia layers will be assessed by visual analogue scale analysis of ultrasound images by three independent reviewers. Images from a previous study will be used to create a 5-point scale of fascia quality(16, 23) which the reviewers will use to assess fascia quality from tissue ultrasounds obtained from our study subjects. SAT fibrosis will be measured by: 1. Echogenicity of SAT and muscle. 2. Tissue Rigidity Assessment
tissue volume assessed by tape measure
时间窗: 30 days
leg volume assessed by circumferential measurements every 10 cm to upper thigh using Jobst measuring board; waist measurements assessed with vertical measurement to the umbilicus and waist and hip circumferential measurements according to WHO guidelines
Quality of life questionnaire
时间窗: 30 days
Quality of life measured by validated questionnaire RAND 36-item Health Survey 1.0 (SF-36)
次要结局
- Thermography(30 days)
- Chart review for vein disease(30 days)
- Improvement in mobility as measured by the Gait-Rite device(30 days)
- Skin biopsy- presence of perpendicularly oriented blood vessels(30 days)
- Improvement in mobility as measured by Timed Up and Go (TUG) test(30 days)
- Chart review - enlarged veins(30 days)