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.