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临床试验/NCT07109674
NCT07109674已完成不适用

Inelastic Compression With a High Stiffness Index in Breast Cancer-related Lymphedema: A Prospective Case - Control Study

University School of Physical Education, Krakow, Poland2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2024年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
2
主要终点
The assessment of limb volume

研究概览

简要总结

Compression therapy based on multilayer compression bandaging and com pression garment use remains the most efficient component of complex physical therapy (CPT) in lymphedema treatment. The proper self-application of compression bandages is generally considered as problematic. Adjustable compression wraps (ACW) have been proposed as an alternative to the commonly used short-stretch bandages for lymphedema. These systems allow easy application and removal for patients. They have been tested in patients with vascular disorders of the lower limbs and can be considered in breast cancer survivors with upper-limb lymphedema.

The objective of this study was to compare the effectiveness, physical functioning and comfort of 2 types inelastic compression: adjustable compression wrap (reduction) and multi-layer compression bandaging at the intensive phase of treatment in advanced upper limb lymphedema among breast cancer survivors.

详细描述

55 women after breast cancer treatment admitted to the Lymphedema Clinic and patients fulfilled the admission criteria - stage-II (according to ISL) lymphedema, ≥20% excess limb volumes, positive pitting skin sign, and absent signs of active cancer, venous thrombosis or previous compression were assigned into the experimental group with the adjustable compression wrap redcution kit, ACW - Group or the control with compression bandaging, CB-Group.

In the ACW reduction group, adjustable compression garments (typ circaid® reduction kit, Medi-Bayreuth) was also fitted based on individual limb measurements with ability to reduce size of garment as the limb volume decreases. The kit included a card with a color scale that allowed users to achieve the appropriate pressure of 20-30 mmHg. The next day, in order to refresh and moisturize the skin, these products were removed for a short period prior to the next therapeutic session. They were used for 24 hours.

In the CB group, multi-layer bandaging of the limb was performed using short stretch bandages with pads (Rosidal K, Lohmann & Raucher). At the beginning of bandaging, a cotton tube stockinet was placed on the arm, a layer of gauze was applied to the fingers and hand. A layer of foam padding (Lymphset: Lohmann & Raucher) was placed on the hand and wrapped around the arm. Three bandages of different sizes (8, 10, 12 cm in width) were placed around the limb with the first starting at the hand, the second at the wrist and the third beginning below the elbow. Sub-bandage pressure was measured via the Kikushime device (Kikgel, Ujazd Poland) on the dorsal part of the forearm, as well as on the arm, to ensure a pressure value within the range of 20-30 mmHg, comparable to pressure used in the compression system among the ACW Group. Bandages were removed for a short time before the therapeutic session the next day, as in the ACW-Group, and put on the next day. The exercise program including aerobic exercises of the upper limbs combined with deep breathing was performed in adjustable compression wraps or bandaging for 15 minutes in 1 session per day.

Measurements, including physical functioning, limb volumes and disease-related symptoms, were performed before the intervention and after treatment in both groups. Circumferential upper limb measurements were taken with the arm abducted at 30°, starting at the level of the ulnar styloid, every 4 cm proximal to this point along both limbs. Calculation of limb segment volumes was carried out using a simplified frustum formula (summed truncated cone). The excess volume was the difference between the affected and unaffected limbs expressed in litres. The percentage reduction of the excess volume was obtained as follows: (excess volume before treatment - excess volume after treatment) x 100/excess volume before treatment.

Patients rated their physical functioning, disease-related symptoms, compression comfort and complications of compression on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. Firstly, the patients assessed their physical functioning (sum of ability to move wrist, elbow, shoulder; use a spoon; carry out work; complete household chores; practice sports' carry out leisure activities; social activities, on the Number Rating Scale (NRS; 0 = not able at all, 10 = completely able) and disease-related symptoms (sum of pain; loss of muscle strength; heaviness; swelling; tight skin; tingling; leakage; NRS: 0 = no complaints, 10 = the highest intensity), first without the tested compression and continued after 1 and 2 weeks using the compression device. Complications of compression related to skin irritation; tender spots; skin damage; itching; warmth; throbbing; cramps; cutting in; slippage; local swelling; bulky feeling; too tight feeling (NRS: 0 = not present at all, 10 = very obviously present, sum of points) were assessed after 1 and 2 weeks in both groups. Compression comfort including: easy donning; easy doffing; feeling immediately after donning; feeling during daytime; putting on clothes on compression; feeling at night; the appearance of the garment (NRS: 0 = not able at all, 10 = completely able, sum of points) was evaluated after the first and second weeks in both groups.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • stage-II of lymphedema (according to ISL)
  • ≥20% excess limb volumes
  • positive pitting skin sign
  • absent signs of active cancer
  • absent of venous thrombosis

排除标准

  • active cancer during oncological treatment
  • using compression
  • stage-I of lymphedema (according to ISL)
  • < 20 % excess limb volumes

结局指标

主要结局

The assessment of limb volume

时间窗: 14 months

Measurements including limb volumes were performed before the intervention, and after treatment in both groups. Circumferential upper limb measurements were taken with the arm abducted at 30°, starting at the level of the ulnar styloid, every 4 cm proximal to this point along both limbs. Calculation of limb segment volumes was carried out using a simplified frustum formula (summed truncated cone). The excess volume was the difference between the affected and unaffected limbs expressed in litres. The percentage reduction of the excess volume was obtained as follows: (excess volume before treatment - excess volume after treatment) x 100/excess volume before treatment.

The assessment of physical functioning

时间窗: 14 months

Patients rated their physical functioning of the affected limb on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. The patients assessed their physical functioning (sum of ability to move wrist, elbow, shoulder; use a spoon; carry out work; complete household chores; practice sports' carry out leisure activities; social activities, on the Number Rating Scale (NRS; 0 = not able at all, 10 = completely able) before and after treatment in both groups.

The assessment of compression comfort

时间窗: 14 months

Patients rated their comfort and complications related to compression on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. Complications of compression related to skin irritation; tender spots; skin damage; itching; warmth; throbbing; cramps; cutting in; slippage; local swelling; bulky feeling; too tight feeling (NRS: 0 = not present at all, 10 = very obviously present, sum of points) were assessed after treatment in both groups. Compression comfort including: easy donning; easy doffing; feeling immediately after donning; feeling during daytime; putting on clothes on compression; feeling at night; the appearance of the garment (NRS: 0 = not able at all, 10 = completely able, sum of points) was evaluated after treatment in both groups.

The assessment of disease - related symptoms

时间窗: 14 months

Patients rated their disease-related symptoms based on the International Compression Club (ICC) Questionnaire - Part for Patients on the Number Rating (sum of pain; loss of muscle strength; heaviness; swelling; tight skin; tingling; leakage; NRS: 0 = no complaints, 10 = the highest intensity) before the intervention and after treatment in both groups.

次要结局

未报告次要终点

研究者

发起方
University School of Physical Education, Krakow, Poland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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