Laser Treatment of Lymphoedema

We report a randomised, placebo controlled, double blind, crossover trial to determine the clinical efficacy of treating post-mastectomy lymphoedema (PML) with Low Level Laser Therapy (LTU-904H, RianCorp Pty Ltd, Australia). Participants in an 'active group' were treated (Rx) three times per week for 3 weeks, 8 weeks interval, then a 2nd 3 weeks Rx. The 'placebo group' received placebo for the 1st 3 weeks, an 8 week break, then active Rx in the 2nd 3 weeks. Patient follow up occurred at 1 and 3 months after cessation of Rx. Participants were treated using a 2cm2 treatment grid of 17 points in the axilla of the affected arm (total energy delivered: 5.1 Joules in 17min, Energy Density: 1.53J/cm2). Outcomes were measured by volume measurements, tonometry bio-impedance, Range of Movement (ROM), and subjective self-reported measures. Bio-impedance showed significant sustained improvements in extracellular fluid content within the treated group (n=37) in the affected arm, trunk and in the unaffected arm. Mean affected limb volume reduction was 59.2ml in the active group at 1month post Rx, compared with 4.9ml after placebo, but this was not significant; power analysis predicted statistical significance between groups with an additional sample size of 15. 22.9% of participants in the active group showed a clinically significant reduction (>5% ~180 ml) in affected arm volume at 1 month follow-up, compared with only 3.6% in the placebo group (p=0.05). Tonometry changes were significantly different between the active and placebo groups in the posterior thorax, and affected upper arm, but not in the affected forearm. Subjective measurements showed significant improvements in most measures between the initial visit and the end of 2nd block of Rx, but these were not significantly different to the placebo group