in treatment are medical devices; should have certification (medical class 2a, DIN EN 60601-1-11) ensuring safe usage in home care setting. IPC is not only used to reduce edema [3], but also to improve blood circulation in patients with arterial circulatory disorders [4, 5] as well as to reduce edema and prevent thrombosis after orthopedic and acci- dent surgery [6]. For lymphological indications, devices with leg cuffs are used, alternatively also panty garments which include the hips and abdomen. Lymphoedema has increased significantly in our society due to the diagnosis “obesity-related lymphoedema”. The demand for physiotherapy is therefore rising sharply. In Germany, the treatment of stage II and III lymphoedema with MLD is reimbursed by the public health care system, which benefits many patients. On the other hand, physical therapy practices are short staffed, making it increasingly difficult for patients to get appointments. There are few studies on the maintenance phase, little information on the necessary frequency of MLD or on alter- natives – similarly, for IPC there are few studies on the sense of single- or multi-stage compression systems, and if so, only over shorter periods of time [2, 9]. Regarding the different possibilities of measures in the maintenance phase, the German guideline Lymphoedema [1] specifies the compulsory wearing of compression, sup- plemented by education on lifestyle, nutritional coun- selling, main skin care as well as exercise therapy and, depending on the clinical situation, the addition of MLD and/or IPC. A study on the effectiveness of both methods in the maintenance phase, in comparison or in addition, is not yet available. Therefore, the aim of the present project is to study patients who are managed in our practice in the “classical” maintenance phase for lymphoedema (round or flat stock- ings, MLD on a regular basis) and who have had relatively constant leg circumference (and BMI) over the last 12 months. These subjects will maintain compression therapy and be treated with IPC+MLD and IPC alone for 4 weeks each, to compare the circumference and volume measure- ments as primary endpoint and the quality of life, as well as acceptance as the secondary endpoint. Patients and methods This is a researcher-initiated, prospective, randomized, cross-over designed study. The patient database of the vein practice was examined for the following keywords: MLD, lymphoedema, at least 3 examinations in the last 12 months with Bodytronic 600. and measured by hand. These patient files were then checked for inclusion criteria: Stage II or III lymphoedema in the maintenance phase, less than 10% vari- ation at measure points of volume, circumferences or BMI within 12 months, age between 18 and 85, ASA 0–1 (not sev- ere illnesses), body weight <150 kg (restriction on volume- measuring). An information letter and consent form were sent to the potential candidates by post or explained and handed over during the check-up in the practice. After an initial interview, the following patients were excluded: Not willing to participate or performing another study, not having space at home for the device, not avail- able in the next 3 months (vacations, planned surgery), not able to attend to controls every 4 weeks in the after- noon (2:00–6:00 pm) or not able to complete the questionnaires. At the first appointment, subjects had to wear their com- pression stockings (as for every control). General informa- tion was recorded (age, weight, height, previous illnesses, side, stage and cause of the lymphoedema, type of previous therapy with compression, frequency and duration of MLD, medication), and subjects completed the Lymph-ICF ques- tionnaire [8], which consists of 28 questions on 5 domains of life, each of which can be rated on a scale of 0–10. Afterwards they were randomized into one of the two groups (IPC alone first or IPC+MLD first) and the compres- sion stockings were removed. The subjects assumed a standing position and pronounced their current complaints (pain, tension or feeling of congestion) using a numerical rating scale (NRS) from 0 to 10, separately for their right and left leg. The examiner recorded whether the edema was hard or soft (pitting). The subjects’ legs were measured manually at the ankle, below the knee and below the crotch with the tape measure by the same trained practice staff and subsequently with the Bodytronic 600. from Bauer- feind. This device is a digital measuring system that records the volume of the feet, calves, knees, thighs and lower torso of standing test persons. The study consisted of three blocks of four weeks of treat- ment each, with compression always worn as basic treatment: The second block was always MLD alone (as before the study), and the order of IPC alone or IPC+MLD for the first or third block was randomized (Figure 1). MLD was performed as usual, by the patient’s therapist of choice, and the same compression stockings were worn. To ensure the correct use of the IPC, Mr. Frank Müller from Figure 1. Study diagram: Patients on MLD (manual lymphatic drainage) and compression hosiery since years and in control in the office were randomized in two groups with controls after each 4 weeks. IPC=intermittent pneumatic compression. All patients were on compression hosiery daily throughout the study. Vasa (2023), 52 (6), 423–431 . 2023 The Author(s) Distributed as a Hogrefe OpenMind article under the license CC BY 4.0 (https://creativecommons.org/licenses/by/4.0) 424 E. Mendoza & F. Amsler, Effect of MLD and IPC in lymphedema https://econtent.hogrefe.com/doi/pdf/10.1024/0301-1526/a001090 - Wednesday, November 29, 2023 2:49:54 AM - IP Address:93.208.161.46
