Can weekly self-bandaging help to maintain the results of the intensive phase and be cost-effective in patients with lower limb lymphedema? (Maintenance-lymph-trial)

In lymphedema swelling appears as a consequence of lymphatic system insufficiency and disturbance of the lymphatic transport.[1] The International Society of Lymphology[1], the Dutch Guideline for lymphedema[2] and the International Lymphedema framework[3] state that decongestive lymphatic therapy (DLT) is the first choice of treatment for lymphedema. This conservative treatment consists of two phases. The aim of the first phase or intensive phase is to reduce the swelling by applying bandages together with skin care, exercises and manual lymph drainage. The aim of the second phase or maintenance phase is to maintain the result by continuing skin care, exercises, manual lymph drainage and replacing the bandages by compression garments. [1-3].
Unfortunately, in practice we notice that it is not easy to stabilize the volume during the maintenance phase. This is confirmed by scientific research in patients with lower limb lymphedema[4, 5].

However, to evaluate lymphedema during this maintenance phase it is important to know which measurement methods are reliable and feasible to use in clinical practice. Following evaluation tools for lower limb lymphedema can be used: perimeter, volumeter, perometer to evaluate the volume; SkinFibroMeter®, palpation tests to evaluate the hardness; increased skin fold, pitting test, MoistureMeter D Compact Device® to evaluate the water content; and bio-impedance multi-frequent analyses/ spectroscopy devices to evaluate extracellular fluid. Reliability, clinical feasibility and validity of these evaluation tools have been demonstrated in patients with upper limb lymphedema.[6-11] However, the clinometric properties of these tools still need to be demonstrated in patients with (bilateral) lower limb lymphedema.[12] Therefore 50 patients with lower limb lymphedema and a control group of 50 persons without lymphedema with comparable characteristics (age, BMI, gender) as the patients with lower limb lymphedema will be asked to participate to evaluate the reliability of these different measurement tools. To investigate intra- and interrater reliability, at first, all measurements are performed by assessor 1, then by assessor 2 and again by assessor 1. To analyze the between-session reliability, in a subgroup of 30 patients and 30 healthy volunteers all measurements are performed 2 weeks later by assessor 1. To investigate clinical feasibility, time needed to perform the measurement as well as the practical limitations associated with the assessment tools (such as cost of the device, complexity of the measurement) will be collected. Since lymphedema affects the quality of life,[13, 14] questionnaires should also be a part of the evaluation. The Dutch version of the lymf-ICF-LL is shown to be a reliable and valid questionnaire to assess the lymphedema-specific quality of life.[15] However, in Belgium French is one of the three official languages. The clinometric properties of the French version have not yet been evaluated in patients with lower limb lymphedema. Forty native French speaking patients with lower limb lymphedema will be asked to fill out the questionnaire 24-48 hours before the consultation and once again at the consultation. To investigate construct validity, the patients also have to  complete SF-36. To investigate face and content validity, its completeness and comprehensibility is questioned.

Since it is not easy to stabilize the volume of lower limb lymphedema in the maintenance phase of DLT, [4, 5] it would be interesting to analyze predicting variables for stabilization of lower limb lymphedema in this phase. For this purpose data of patients who participated at the multidisciplinary care program for lower limb lymphedema and had their 6 months follow-up appointment between May 2018 and November 2021 will be retrospectively collected. Predictive variables (i.e. patient specific, lymphedema specific and lymphedema treatment specific variables) for a better lymphedema-specific quality of life (Lymph-ICF-LL questionnaire) and less volume changes (circumferential measurements) at 6 months follow-up will be assessed. One study that analyzed predicting variables in the maintenance phase in patients with upper limb lymphedema found that wearing low-stretch multilayer bandages overnight on top of wearing the compression garment during the day, significantly lowered the risk of treatment failure.[16] Therefore, weekly self-bandaging additional to compression garment, skin care, (manual lymph drainage) and exercises in patients with lower limb lymphedema could possibly help to stabilize the volume in the maintenance phase and be cost-effective. To investigate the additional effect of self-bandaging 200 patients with primary or secondary and unilateral or bilateral lower limb lymphedema who just finished the intensive phase at the multidisciplinary care program for lymphedema will be included. 100 patients will receive the usual care (DLT) according to the advice given at the multidisciplinary care program. The other 100 patients will have to , besides to the usual care, bandage the affected limb(s) three nights a week for the first three months. The following 6 weeks these patients will be asked to apply the bandages two nights a week and the last 6 weeks only one time a week. Patients who cannot apply bandages themselves will be excluded. All patients will be evaluated at the end of the intensive phase and at 3 and 6 months follow-up. Data at the start of the intensive phase will be retrospectively  collected, since inclusion will take place after the start of the intensive treatment. The evaluations consist of questionnaires about quality of life and compression; volume measurements (circumferential measurement and water displacement method); interface-pressure under the compression garment (PicoPress) and an interview (amount of infections, necessity to apply bandages in case the volume is increased >50% of the volume reduction obtained in the intensive phase). Besides the possible clinical advantage, it is also important to consider the economic consequences and the cost-effectiveness of the additional bandaging in this chronic condition. For this purpose additional information will be collected about the direct and indirect medical costs through a monthly questionnaires which will be send to the patients.

REFERENTIES

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2.            Damstra, R.J. and A.B. Halk, The Dutch lymphedema guidelines based on the International Classification of Functioning, Disability, and Health and the chronic care model. J Vasc Surg Venous Lymphat Disord, 2017. 5(5): p. 756-765.

3.            framework, L., Best practice for the management of lymphedema. International Consensus. 2006.

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5.            Kim, Y.B., et al., Would complex decongestive therapy reveal long term effect and lymphoscintigraphy predict the outcome of lower-limb lymphedema related to gynecologic cancer treatment? Gynecol Oncol, 2012. 127(3): p. 638-42.

6.            Devoogdt, N., et al., A new device to measure upper limb circumferences: validity and reliability. Int Angiol, 2010. 29(5): p. 401-7.

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8.            Taylor, R., et al., Reliability and validity of arm volume measurements for assessment of lymphedema. Phys Ther, 2006. 86(2): p. 205-14.

9.            Warren, A.G., et al., The use of bioimpedance analysis to evaluate lymphedema. Ann Plast Surg, 2007. 58(5): p. 541-3.

10.         Yu, Z., et al., Assessment of Skin Properties in Chronic Lymphedema: Measurement of Skin Stiffness, Percentage Water Content, and Transepidermal Water Loss. Lymphat Res Biol, 2020. 18(3): p. 212-218.

11.         De Vrieze, T., et al., Reliability of the MoistureMeterD Compact Device and the Pitting Test to Evaluate Local Tissue Water in Subjects with Breast Cancer-Related Lymphedema. Lymphat Res Biol, 2020. 18(2): p. 116-128.

12.         Hidding, J.T., et al., Measurement Properties of Instruments for Measuring of Lymphedema: Systematic Review. Phys Ther, 2016. 96(12): p. 1965-1981.

13.         Carter, J., et al., GOG 244 - The Lymphedema and Gynecologic cancer (LeG) study: The impact of lower-extremity lymphedema on quality of life, psychological adjustment, physical disability, and function. Gynecol Oncol, 2021. 160(1): p. 244-251.

14.         Park, J.E., H.J. Jang, and K.S. Seo, Quality of life, upper extremity function and the effect of lymphedema treatment in breast cancer related lymphedema patients. Ann Rehabil Med, 2012. 36(2): p. 240-7.

15.         Devoogdt, N., et al., Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL): reliability and validity. Phys Ther, 2014. 94(5): p. 705-21.

16.         Vignes, S., et al., Factors influencing breast cancer-related lymphedema volume after intensive decongestive physiotherapy. Support Care Cancer, 2011. 19(7): p. 935-40.