Concordance and acceptability of electric stimulation therapy: a randomised controlled trial.

OBJECTIVE: A pilot single-blinded randomised controlled trial (RCT) was conducted to examine concordance with and acceptability of electric stimulation therapy (EST) in patients with venous leg ulcers (VLUs) who had not tolerated moderate to high compression. METHOD: Participants were randomised to the intervention group (n=15) or a placebo control group (n=8) in which EST was used four times daily for 20 minutes per session. Participants were monitored for eight weeks during which time concordance with the treatment and perceptions of the treatment were assessed. RESULTS: Concordance with the total recommended treatment time was 71.4% for the intervention group and 82.9% for the control group; a difference that was not statistically significant. Participants rated EST as acceptable (84.6% intervention; 83.3% control), only two participants, both from the placebo control group, would not be willing to use EST again. The majority considered EST easier to use than compression (68.4%). CONCLUSION: EST was a practical and acceptable treatment among people who have been unable to tolerate moderate to high compression therapy.

Venous leg ulcer healing with electric stimulation therapy: a pilot randomised controlled trial.

OBJECTIVE: Compression therapy is a gold standard treatment to promote venous leg ulcer (VLU) healing. Concordance with compression therapy is, however, often sub-optimal. The aim of this study was to evaluate the effectiveness of electric stimulation therapy (EST) to facilitate healing of VLUs among people who do not use moderate-to-high levels of compression (>25 mmHg). METHOD: A pilot multicentre, single-blinded randomised controlled trial was conducted. Participants were randomised (2:1) to the intervention group or a control group where EST or a sham device was used 4 times daily for 20 minutes per session. Participants were monitored fortnightly for eight weeks. The primary outcome measure was percentage of area (wound size) change. RESULTS: In the 23 patients recruited, an average redution in wound size of 23.15% (standard deviation [SD]: 61.23) was observed for the control group compared with 32.67 % (SD: 42.54) for the intervention. A moderate effect size favouring the intervention group was detected from univariate [F(1,18)=1.588, p=0.224, partial eta squared=0.081] and multivariate repeated measures [F(1,18)=2.053, p=0.169, partial eta squared=0.102] analyses. CONCLUSION: The pilot study was not powered to detect statistical significance, however, the difference in healing outcomes are encouraging. EST may be an effective adjunct treatment among patients who have experienced difficulty adhering to moderate-to-high levels of compression therapy.

Liposuction of Postmastectomy Arm Lymphedema Decreases the Incidence of Erysipelas.

The objective of this study was to assess erysipelas incidence before and after liposuction treatment for patients suffering from post-mastectomy lymphedema. A prospective cohort study of 130 patients at Skåne University Hospital in Malmö, Sweden with postmastectomy arm lymphedema, who had poor outcomes from prior conservative treatment and clinical signs of subcutaneous adipose tissue hypertrophy, underwent liposuction between 1993-2012. Pre- and postoperative incident data on erysipelas were available for all of them. Mean duration of lymphedema prior to liposuction was 8.8 years (range1-38, standard deviation (SD) 7.0 years). Mean age at liposuction was 63 years (range 39-89, SD 10 years). Total pre-liposuction observation years were 1147, and total post-liposuction observation years were 983. Erysipelas incidence dropped significantly (p<0.001) from 0.47 attacks/year (range 0-5.0, SD 0.8 attacks/year) to 0.06 attacks/year (range 0-3.0, SD 0.3 attacks/year) after liposuction, a reduction of 87%. Also, compared to 76 patients who experienced at least 1 erysipelas episode preoperatively, only 13 patients experienced erysipelas postoperatively. Of the 54 patients who did not have erysipelas preoperatively, 6 patients had erysipelas postoperatively. The total number of erysipelas attacks observed decreased from 534 to 60 bouts after liposuction. The excess arm volume of 1607 ml (range 570-3950, SD 707) was reduced to -43 ml (range -945 to 1390, SD 379) after 6 months and was maintained during the postoperative follow-up period of, at most, 18 years. Our data suggest that liposuction can significantly reduce incidence of erysipelas in patients with post mastectomy arm lymphedema who prior to the intervention suffered one or more attacks.

A 10 Minute Self-Care Program May Reduce Breast Cancer-Related Lymphedema: A Six-Month Prospective Longitudinal Comparative Study.

Patients with breast cancer-related lymphedema (BCRL) need a life-long self-care program that they can adhere to enable them to manage their lymphedema. The objective of this study was to assess the effectiveness of a holistic BCRL self-care program that patients could easily adhere to and comply with. A prospective, longitudinal, comparative study between affected arms and unaffected arms in unilateral breast cancer patients was implemented over a six-month period. Both the lymphedematous and unaffected arms of 23 patients with unilateral BCRL were followed and measured. The daily 10-minute holistic BCRL self-care program consisted of modified Japanese rajio taiso (Japanese radio calisthenics), a gentle arm exercise combined with deep breathing, skin moisturizing care using a traditional lymphatic drainage technique, and basic self-care education. Arm and edema volume, relative volume change, resistance of the skin to compression (fibrosis), lymphedema-related symptoms, skin condition, and self-care were assessed. At the end of six-months the volume of all limb segments and resistance of the tissues to compression at all measurement points of the affected arm were significantly reduced. On the unaffected side, only the volume of the forearm and the whole arm was significantly reduced and fibrosis significantly reduced only in the forearm. There was no significant difference in edema volume and relative volume change. Lymphedema-related symptoms significantly improved. Perceived adherence, effectiveness, burden, score and average time for self-care significantly increased. Our results demonstrate that this 10-minute self-care program may improve BCRL and its self-care.

Pilot study of the impact of sporting compression garments on composition and volume of normal and lymphedema legs.

Once clinically manifested as a swollen limb, lymphedema can be difficult to manage. Our focus thus must shift from reactive treatment to proactive management and prevention. On the basis of strong evidence in the literature, lymphedema specialists now encourage exercise as it can improve lymphatic drainage through muscle pump action. However, exercise may increase the lymph load on the vulnerable limb. We aimed to examine whether low level sporting compression is a reasonable recommendation for those with early stage lymphedema by measuring whether sporting compression (SC) tights decrease limb extracellular fluid as measured by Bio-impedance Spectroscopy (BIS) and Perometry in legs following exercise in both healthy controls and those with early stage lymphedema. A group of normal subjects (n=10) and a group of Stage 1 (ISL) lymphedema patients (n=9) were enrolled. Efforts were made to match participants in each group. For those with unilateral lymphedema, the non-affected leg was used as a control. All were measured using BIS, Perometry and Indurometry before and after exercise both with and without sporting compression clothing. The exercise regime was standardized and involved treadmill walking at increasing rates within each person's activity limitation. SC tights were shown to significantly decrease the fluid build up caused by exercise in lymphedema-affected limbs as measured with BIS (p=0.0302). Perometry measurements showed that SC caused a significant decrease in limb volume post exercise of the whole cohort (p=0.0081) and of the control Group B (p=0.0348). Our findings support the notion that SC may provide a socially acceptable and effective means of lymphedema control during exercise for early lymphedema management.

Reliability of bioimpedance spectroscopy and tonometry after breast conserving cancer treatment.

BACKGROUND: Measuring the female breast, especially after breast cancer treatment, is problematic due to breast size, texture, and patient positioning. However, being able to accurately measure changes in the breast is important, as it may help in the earlier diagnosis and treatment of early breast edema and later lymphedema. METHODS: 14 women who had undergone breast conserving surgery for breast cancer (> 12 months ago) were recruited to assess the between subject reproducibility of tonometry and bioimpedance spectroscopy (BIS). With the participant supine, two repeat measurements of the resistance of the tissues to compression (tonometry) and fluid levels (BIS) of the treated and normal breast were taken for each of the four quadrants of the breast. RESULTS: The between subject reproducibility for both measurement techniques was high, with covariance ranging from 1.29% to 3.25% for tonometry and 0.20-0.86% for BIS. CONCLUSIONS: The reliability of these two measurement techniques provides an opportunity for researchers and clinicians to easily quantify breast tissue and fluid changes which in turn may lead to the earlier diagnosis and targeted treatment of breast edema and lymphedema.

In Memoriam Prof. Prof. h.c. Dr. med. Michael Földi, January 10, 1920 - October 20, 2018 "Father of Lymphology".

In Memoriam: With deep sadness the world of Lymphology learned of the death of Prof. Prof. h.c. Dr. med. Michael Földi, a ground breaking pioneer of modern Lymphology. Words alone will never fully describe or capture the breadth and depth of Michael's contribution to our lymphatic knowledge and the legacy he has left for us all.

Endermologie (with and without compression bandaging)--a new treatment option for secondary arm lymphedema.

Two treatment protocols are presented using the LPG Endermologie system in combination with compression bandaging as a new treatment option for secondary arm lymphedema. Both protocols were applied 4 days a week for 4 weeks but differed in Trial II in time spent clearing the regions of the trunk adjacent to the swollen limb and the addition of a larger treatment head so that a greater area could be covered more quickly. The first protocol involved 24 women and the second involved 10 women. At the end of the treatment period, both protocols demonstrated overall reductions in limb volume (134mls; 18.3% p = 0.000 and 185mls; 28%, p = 0.002), limb fluid (182mls; 28%, p = 0.000 and 216mls; 33%. p = 0.014), truncal fluid (342mls; p = 0.002 and 290mls; p = 0.066), improvements in fibrotic induration in some lymphatic territories, and significant improvements in subject reporting of heaviness, tightness, tissue hardness and limb size. Trial II demonstrated additional benefits in terms of reduction in whole arm volume at 24 hours, improved fluid and arm volume reductions, and a significant improvement in subject reported arm range of movement. The additional time spent clearing the regions adjacent to the swollen limb in the second protocol appears to produce an increase in limb volume and limb fluid loss compared to the original treatment protocol.

The effect of gentle arm exercise and deep breathing on secondary arm lymphedema.

The aim of this study was to explore the benefits of gentle arm exercise combined with deep breathing for secondary arm lymphedema. 38 women participated in 10 minutes of standardized arm exercise and deep breathing and were measured every 10 minutes for 1 hour, then 24 hours and 1 week post regime. A smaller cohort of 24 women continued the 10 minute exercise regime morning and evening for 1 month, with measurements being repeated at the end of this time. Directly after performing the regime, there was a reduction in arm volume of 52 mls (5.8%), with the reduction being sustained at 30 minutes (50 mls, 5.3%). Even though participants were told not to further do the exercise, at 24 hours the volume reduction was 46 mls (4.3%) and at 1 week, 33 mls (3.5%). At the one month follow-up, the reduction was 101 mls (9.0%). All reductions were statistically significant. Reported arm heaviness and tightness also statistically significantly decreased directly after the regime with the reduction in tightness being sustained at 24 hours. The reduction in heaviness was sustained at 24 hours, 1 week, and even one month after the program. Perceived limb size was significantly reduced at 1 week and at the 1 month follow-up. There was also a significant improvement in the anterior thorax tonometry reading at the 1 month follow-up.

Indurometer vs. Tonometer: Is the Indurometer Currently Able to Replace and Improve Upon the Tonometer?

BACKGROUND: The Indurometer is a tool designed by the Flinders Biomedical Engineering Department to replace the Tissue Tonometer. It measures the resistance to an applied force to quantify the amount of fibrosis present within the epifascial compartment of tissue. The aim of the study was to compare the current model of the Indurometer with the Tonometer to determine the level of variability and repeatability between the two devices and how the variability differs when compared to an individual's ISL stage. METHODS AND RESULTS: Data were gathered on a total of 180 participants with unilateral arm lymphedema as part of an international multicenter trial. For each participant three repeat measurements were obtained with the Indurometer and Tonometer at the anterior mid forearm and anterior mid upper arm. The Indurometer gave lower measurement values than the Tonometer. The Tonometer was found to be less variable than the Indurometer when measurements were taken from the anterior mid upper arm and the anterior mid forearm site. The Tonometer values were significantly less variable than the Indurometer values in ISL stages 1 and 2. No significant variability was found in stage 3. CONCLUSION: The Indurometer is easier to use as compared to the Tonometer. Modification of the Indurometer needs to take place in order to improve its variability before it can be considered as a replacement for the Tonometer in the assessment of lymphedema. The lack of understanding of the ISL classification system is a significant issue.

Energy flow in light-coupling masks for lensless optical lithography.

We illustrate the propagation of light in a new type of coupling mask for lensless optical lithography. Our investigation shows how the different elements comprising such masks contribute to the definition of an optical path that allows the exposure of features in the 100-nm-size range in the photoresist.

The lymphogogue action of calcium dobesilate on the flow of lymph from the thoracic duct of anesthetized and mobile guinea pigs.

Calcium dobesilate increases thoracic duct lymph flow in both anesthetized and mobile guinea pigs. The marked lymphogogue action of this drug may explain in part the improvement in tissue survival with ischemic insult.

Lymphoedema, macrophages and benzopyrones.

The role of macrophages in lymphoedema is discussed, with particular reference to post mastectomy lymphoedema. In the latter, the normal course of events is detailed using clinical and experimental evidence. Particular importance is placed on the events of the latent phase since it is during this time that important changes are occurring in the functioning of the blood-tissue-lymph system. These changes are not usually demonstrable clinically until the end of the latent phase when lymphoedema becomes manifest. Evidence suggests that the majority of these changes can be linked with changes in the functioning of the members of the mononuclear phagocytic system. Of particular importance is the disruption to the normal tissue remodelling processes as we know in lymphoedema the delicate balance between the deposition and lysis of collagenous fibres is shifted in favour of deposition--thus fibrosis occurs. The basic mechanisms behind such changes are discussed. A group of drugs, called the benzopyrones have been shown both clinically and experimentally to be of benefit in reducing most forms of high protein oedemas including lymphoedema. It is shown that they can do this by stimulating the rather depressed functioning of the members of the mononuclear phagotic system. The exact mechanism of action of these drugs is discussed with particular emphasis on coumarin which is one of the components of Venalot.

Conservative treatment of acute and chronic lymphoedema with benzo-pyrones.

Generally, the success of conservative therapy is only limited to a transient reduction in oedema. Concomitant with this, subjective improvements such as a reduced feeling of heaviness, a lessening of pain and of the bursting feeling of the affected limb are frequently reported. Once the oedema is reduced, the reduction must be maintained by elevation, elastic compression bandages, and by careful attention to infection. A failure to observe these points results in a very rapid reformation of the oedema. Experimental results have shown the benzopyrones to be very useful in reducing high protein oedemas, particularly those of lymph and thermal oedema. They do this by enhancing the lysis and removal of the abnormal accumulated protein from the affected part. They also enhance glucose uptake by the various cells, thus allowing them to survive in a viable state in severe conditions such as those of metabolic acidosis characteristic of stagnant tissue fluids. Since the benzopyrones remove the excess protein, the tendency for further fibrotic tissue formation is reduced. In addition, like some other anti-inflammatory drugs, the benzopyrones may be able to enhance the removal of existing fibrotic tissue by causing its lysis. The cells involved in this action seem to be the macrophages. The remarkable reductions of lymph and thermal oedemas obtained in animal experiments with the benzopyrones have not been reported in many clinical trials. There seem to be two main reasons for this. Firstly much lower doses are used than have been shown to be optimal. Secondly, the follow up periods of observations have usually only been short. Some clinical trials even with these lower doses have however been very promising, and this is especially enlightening when it is considered that such doses in animals only result in minimal changes in the oedema volume. This may be the reason for the high proportion of "subjective improvement only" reports in clinical trials.

The use of a tissue tonometer as a diagnostic aid in extremity lymphoedema: a determination of its conservative treatment with benzo-pyrones.

With the aid of a tissue tonometer, we have been able to gain an estimate of the rate at which the lymphoedematous tissue loses its compressability and regains it upon treatment with the non-steroidal anti-inflammatory drugs: the benzo-pyrones. The values obtained by tonometry, unlike other objective methods of measurement of the effectiveness of a therapy, approximate closely to the patients subjective claims.

Treatment of chronic postmastectomy lymphedema with low level laser therapy: a 2.5 year follow-up.

Ten women with unilateral arm lymphedema after axillary clearance (radical mastectomy) and radiotherapy for breast cancer received 16 treatment sessions with Low Level Laser Therapy (LLLT) over 10 weeks and seven patients were followed for 36 months. The effect of LLLT was monitored by arm circumference, plethysmography, tonometry, bioimpedance and a questionnaire dealing with subjective symptoms. After treatment, edema volume (both extracellular and intracellular) was decreased, the tissue (except for the upper arm) progressively softened or approached a normal texture, and the patients reported improvement in aches/pains, tightness, heaviness, cramps, pins/needles, and mobility of the arm. Skin integrity was also improved and the index for risk of infection decreased. Follow-up assessment at 1, 3, 6, and 30-36 months showed varying trends although at 30-36 months most subjective parameters and bioimpedance derived data on ECF and ICF tended to return toward pre-treatment levels. Arm circumference continued to show overall improvement, however, with a volume reduction of the affected arm reaching 29%. Tonometry also showed maintenance of near normal values for the involved forearm and anterior and posterior chest; however, the upper arm showed progressive induration. The data suggest that laser treatment, at least initially, improved most objective and subjective parameters of arm lymphedema.

Combined opto-electronic perometry and bioimpedance to measure objectively the effectiveness of a new treatment intervention for chronic secondary leg lymphedema.

Secondary lymphedema of the legs is a common sequela of patients treated for cancer of the reproductive, gastrointestinal, urinary systems and melanoma. From a clinical and research perspective it is of utmost importance to use techniques that objectively quantify leg volume and fluid composition as an indicator of lymphedema severity and response to treatment. Two techniques often used in both the clinical and research setting are leg perometry and multi-frequency bioimpedance. Although both techniques have been extensively validated, this trial aimed to cross correlate both measurement techniques to ascertain whether each or both could be used reliably for measurement of leg lymphedema. These measurements were utilized throughout a clinical trial that assessed the effectiveness of a new home based treatment program in the form of the Sun Ancon Aerobic Exerciser. This machine delivered both elevation and passive exercise to the legs, with participants using the machine over a three week period during which time their leg volumes were measured using both perometry and bioimpedance. The results demonstrated that leg volume measurements decreased using both perometry and bioimpedance. The reduction in body extracellular fluid as measured by bioimpedance correlated well with a reduction in leg volume as measured by perometry. Bioimpedance also recorded a reduction in weight, which was correlated with the reduction in leg volume as measured by perometry. This trial confirms that perometry and bioimpedance were both effective in independently showing a reduction in leg lymphedema using the Aerobic Exerciser therapy, and that both methods can be reliably used to measure and follow leg lymphedema.

A new instrument for the evaluation fo tissue tonicity in lymphoedema.

An instrument which measures the resistance of the tissues to compression has been used to assess the effectiveness of a therapy for long term lymphoedema. In this preliminary study, all cases of long standing lymphodema showed an increased resistance of the affected tissue to compression. Following an average of 30 months' Venalot treatment the resistance of the fibrotic tissues was restored to normal levels. It is believed that this way of assessing the state of the tissues and the value of therapy is a more accurate representation of the actual situation and should be used in preference to measurement of the circumference or plethysmography.

The Sun Ancon Chi Machine Aerobic Exerciser: a new patient focused, home based therapy for people with chronic secondary leg lymphedema.

A significant proportion of those who survive lower torso cancer treatments will go on to develop clinically discernible bilateral or unilateral leg lymphedema. Although beneficial treatments exist for this condition, many are expensive and involve visits to outpatient clinics or allied health professionals--making the patient dependent upon others for treatment and maintenance. This clinical trial tested the efficacy of the Sun Ancon Chi Machine Aerobic Exerciser, a home based therapy that delivered both elevation and passive exercise to the legs. This machine was used in the participant's home according to a set regime with measurements being taken immediately before trial commencement, at weekly intervals and then 1 month after treatment cessation. After a three week treatment period there were statistically significant reductions in total leg volume and fluids, whole body extracellular fluid, weight and subjective leg symptoms. Lymphscintigraphy in a sub-group of patients suggested an increase in lymphatic transport in some individuals. Although some of the fluid and symptoms had returned at the 1 month follow up, none of the parameters had returned to pre-treatment levels. This finding indicates that this equipment may have ongoing beneficial effects. This clinical trial demonstrates that the Sun Ancon Chi Machine Aerobic Exerciser is an effective adjunct therapy that can be used in the patient's own home.

Tissue changes in chronic experimental lymphoedema in dogs.

Chronic lymphoedema was experimentally induced in the legs of dogs and studied with the electron microscope, including by quantitation. It was found that some cells (macrophages, fibroblasts and, to a lesser extent, lymphocytes) increased greatly in numbers and relative volumes. Collagen (and fat cells) also greatly increased in relative volume. The lengths of blood vessels and initial lymphatics were much greater in the injured tissue. The numbers of small vesicles and vacuoles rose greatly in both types of vessels. Both also had many open endothelial junctions--although no doubt from different causes. It is probably caused by excessive accumulations of proteins, so chronic lymphoedema is probably a form of chronic inflammation.