Manual Lymph Drainage in Lower Extremity Lymphedema Management: An Essential Component or An Optional Extra? A Single-Blind, Randomized Non-Inferiority Trial.

OBJECTIVE: To determine whether compression bandaging (CB) alone is non-inferior to CB combined with manual lymphatic drainage (MLD) in terms of reducing limb volume, tissue stiffness, and skin/subcutaneous thickness during the intensive phase of Stage 2-3 lower extremity lymphedema (LEL) treatment. DESIGN: A single-blind, randomized non-inferiority trial. SETTING: xxx University, Department of Physiotherapy and Rehabilitation, xxx Physical Therapy and Rehabilitation Training and Research Hospital. PARTICIPANTS: A total of 32 extremities with Stage 2-3 LEL were randomly assigned to either the CB group (n = 16) or the CB+MLD group (n = 16). Thirty-one extremities completed the study (CB: n = 16; CB+MLD: n = 15). INTERVENTIONS: Interventions were administered 5 days a week for 4 weeks. The CB group received CB alone, while the CB+MLD group received a combination of compression bandaging and MLD. MAIN OUTCOME MEASURES: The primary outcome was percentage volume reduction (PVR), with a pre-specified non-inferiority margin (Δ) of -5%. Secondary outcomes included tissue stiffness measured via SkinFibroMeter, and skin and subcutaneous thickness evaluated using ultrasound at 17 standardized points across the lower extremity. RESULTS: Both groups achieved significant reductions in limb volume (p<0.001, Cohen's d: 1.35 for CB, 1.49 for CB+MLD). No significant difference in PVR was observed between the CB (19.67±8.47%) and CB+MLD (22.23±8.74%) groups (p=0.466). The 95% confidence interval for the mean difference in PVR was [-4.57,9.68], which remained within the field non-inferiority margin. Both groups also demonstrated significant improvements in distal tissue stiffness (p<0.001, d: 1.27 for CB, 1.32 for CB+MLD) and subcutaneous thickness (p<0.001, d: 1.06-1.24), with no significant inter-group differences (p>0.05). CONCLUSIONS: CB alone is non-inferior to CB+MLD for reducing edema and tissue stiffness in Stage 2-3 LEL. Consequently, prioritizing appropriate compression may allow for more cost-effective and less time-consuming treatment strategies without compromising therapeutic efficacy.