Bösl-Medizintechnik was always present at the first appointment and instructed the patient in the use of the Lymphamat 300, a compression pant from toes to waist, with 12 chambers per leg (total 24 chambers). The devices were collected after the end of the 1st phase so that no IPC could be applied during the “MLD only” phase. The Bösl company was always available to the patients by phone and in person for any questions. Patients were given home documents with a question- naire to check off MLD appointments in the next 4 weeks and a sheet to record the frequency of IPC and intensity of cessation. The same examinations and questionnaires were repeated at each control appointment. At last, the sub- jects were additionally invited to give an assessment of the effectiveness and practicability of the three options in the form of an additional questionnaire. The study was advised by the Ethics Committee of the Hanover Medical Association and deemed harmless (BO/ 23/2020); it complies with the requirements of the Helsinki Convention. Statistics The number of subjects needed could not be determined at the beginning, as no empirical values were available. Based on of the evaluating of decongestion in one afternoon [9], 20 participants seemed to be sufficient for a result in the research question. A maximum of 100 participants should be included, but an interim evaluation should be performed after every 20 participants and, if necessary, the study should be terminated if the significance is sufficient. The variables collected were partly related to the person (e.g. quality of life) and partly to the individual leg (circum- ference, volume, discomfort) – for the latter, the mean val- ues were calculated if both legs were affected, otherwise only the value for the affected leg was used. For the Lymph-ICF questionnaire, the mean value of the answered individual items was calculated for the 5 dimensions and the total value (0–10 in each case). The results are presented by mean, and standard devia- tion as well as median, minimum and maximum. In order to compare the different treatments, t-tests for paired sam- ples were calculated. In addition to the significance calcu- lation, Cohen’s d was calculated as a measure of the effect size of the differences. According to Cohen, d=0.2 mean “small”, 0.5 “medium” and .0.8 large effect sizes. [10]. Results The first evaluation after 20 subjects showed no differ- ences between the different treatment options related to the primary endpoint (circumferences and volume), so fur- ther recruitment was stopped. There were 10 subjects randomized to the “IPC first” group and 10 randomized to the “IPC+MLD first” group, 15 women and 5 men. From the second group, 2 subjects dropped out of the study prematurely and were excluded: One subject with osteoarthritis had severe knee pain and did not tolerate the pressure of IPC; One subject felt uncomfortable under IPC and did not want to continue using it. Therefore, the evaluation was carried out with 18 subjects, 14 female, 4 men, mean age 59.6 years (48–79), mean BMI at start 33.7 (20.9–47.2), 5 primary and 13 secondary lymphedemas (further information in electronic supplementary material [ESM] 1). The IPC-sessions lasted 45–60 minutes and their fre- quency varied during the 4 weeks of treatment between 12 and 42 applications (mean 21.8±8.3) in the phase “IPK alone” and between 11 and 39 applications (mean 20.8 ±8.2) in the phase “IPK+MLD”. The mean pressure varied from 31 mmHg to 104 mmHg (mean 63.5±5.2). The fre- quency of MLD during the phases “MLD alone” and “MLD+IPC” hardly changed compared to “before the study”: Objective results Circumferences and leg volumes All measurements were taken between 2 and 6 p.m., the variances between the measurement times for the individ- ual persons were very small. Figures 2A–2D show the manually measured circumfer- ences of ankle and calf and the machine-measured vol- umes of calf and thigh at each measurement point for each participant, Figure 3A–3D the changes of mean values as box-blots. Table I shows the mean values at every mea- surement point and their differences in relation to each other. There were significant differences only for the ankle circumference: it decreases significantly in the phase “IPC +MLD” (.0.22 cm) compared to the baseline value (Cohen’s d 0.08) and is also significantly smaller compared to “IPC alone” (Cohen’s d 0.07). Calf circumference tends to decrease in all treatment variants, but these changes are not statistically significant (Cohen’s d 0.01–0.08). There are no significant differences in calf and thigh volume (Cohen’s d 0.00–0.04). 4 patients with secondary lymphedema after oncologic surgery finished the survey, equally distributed (2 in each group), aged between 55 and 79, 1 male, 3 females. Their results do not differ from the general group and all 4 patients prefer the combination of MLD and IPC as best treatment. Changes in complaints and quality of life The mean value of the complaints according to the numer- ical analogue scale on the day of admission was 2.5±2.8. Figures 2E and 2F show the development of complaints and QoL on the day of examination. . 2023 The Author(s) Distributed as a Hogrefe OpenMind article Vasa (2023), 52 (6), 423–431 under the license CC BY 4.0 (https://creativecommons.org/licenses/by/4.0) E. Mendoza & F. Amsler, Effect of MLD and IPC in lymphedema 425 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
