Introduction: Complete Decongestive Therapy (CDT) is the first choice of treatment according the current clinical guidelines for lymphedema. This conservative treatment consists of two phases. Whereas the first or intensive phase aims to reduce the swelling as much as possible by multilayer bandaging, exercises, skin care and manual lymph drainage (if necessary); the second or maintenance phase focuses on maintaining the reduction by promoting self-management, continuing skin care, exercises, manual lymph drainage (if necessary) and replacing the multilayer bandages by compression garments during the day. Unfortunately, in clinical practice and according to previous clinical studies, the maintenance phase of DLT is insufficient to perfectly stabilize the volume in the maintenance phase. Therefore, many lymphedema clinics, clinical guidelines and studies already include compression therapy during the night in the maintenance phase. However, the additional effect of nighttime compression in the maintenance phase in patients with lower limb lymphedema has never been investigated.
Aim: To investigate the added value of nighttime self-bandaging and its cost-effectiveness in the maintenance phase in addition to exercise, skin care, manual lymph drainage (if necessary) and wearing compression garments during the day in patients with lower limb lymphedema.
Method: 198 patients with primary or secondary lower limb lymphedema will be recruited during their multidisciplinary intensive treatment in two hospitals specialized in lymphedema treatment, i.e. UZ Leuven and CHU UCL Namur. During this intensive treatment all patients receive multilayer bandaging, skin care, if needed manual lymph drainage, exercises and educational sessions about lymphedema treatment and self-management, including self-bandaging. At the end of the intensive treatment patients will be randomized in either the intervention (N=99) or control (N=99) group. Both groups will be asked to wear the compression garment during the day, continue the exercises, skin care (and if needed manual lymph drainage). Additionally, the intervention group will be asked to apply self-bandages three times a week during the first two months, two times a week the third and fourth month and once a week the fifth and sixth month after the end of the intensive phase. Thereafter, all patients are free to continue or start self-bandaging or not. Patients are evaluated at the end of the intensive phase and at two, four, six and twelve months follow-up by an assessor blinded for allocation to the intervention or the control group. During these visits following aspects will be assessed: volume of the limbs (circumferential measurements at the legs, water displacement at the feet); (lymphedema-) specific quality of life (EQ-5D-5L and Lymph-ICF-LL); acceptance and experience of the compression garment (ICC compression questionnaire); infection rate (interview) and the need for an intensive treatment (in case ≥50% increase of the reduction during the intensive phase). Interface pressure (standing, resting and dynamic with PicoPress) and static and dynamic stiffness index of the new compression garment will be measured at the end of the intensive phase and two months follow-up (also at four and six months in case no new compression garment was measured). Direct medical and non-medical costs and the applied therapies will be evaluated every month (self-developed questionnaires). At twelve months follow-up patients will receive an additional questionnaire with questions about whether they continued or started self-bandaging or not.
Conclusion: The results of this study will indicate if nighttime bandaging should be further encouraged in patients with lower limb lymphedema to stabilize the edema in the maintenance phase.
Dra. An-Kathleen Heroes - Dpt Revalidatiewetenschappen, KU Leuven. Centrum voor lymfoedeem, UZ Leuven, campus Pellenberg. (Belgium)
Prof. Dr. Nele Devoogdt - Dpt Revalidatiewetenschappen, KU Leuven. Centrum voor lymfoedeem, UZ Leuven, campus Pellenberg. (Belgium)
Prof. Dr. Sarah Thomis - Dpt. Vasculaire Heelkunde & Centrum voor lymfoedeem, UZ Leuven. (Belgium)
Dra. Charlotte Van Calster – Dpt Revalidatiewetenschappen, KU Leuven. (Belgium)
Mevr. Jacqueline Frippiat - Centre de référence du lymphoedème, CHU UCL Namur, site Godinne. (Belgium)