At-home, Self-applied B-cure Laser Photobiomodulation Reduces Disability Following Arthroscopic Rotator Cuff Repair - A Double-blind, Sham-controlled, Randomized Clinical Trial

Background and Objectives: The first month following rotator cuff arthroscopic surgery (RCAS) is characterized with significant disability. Photobiomodulation (PBM), a non-ionizing radiation in the red to near-infrared range has been shown to accelerate wound healing and reduce pain. PBM was specifically shown to be safe and effective in shoulder conditions, but required multiple treatments. However, arriving at the clinic during the first period post-surgery is difficult. The current study was therefore designed to evaluate the efficacy of self-applied PBM treatments at home, during the first month post-RCAS.

Methods: This is a prospective, double-blind, sham-controlled, randomized, clinical trial (NCT04593342). Patients (n=37, Age 56±7yo, Male:Female 19:18) that underwent primary RCAS were randomized to receive active (n=20) or sham (n=17) B-Cure Laser devices (Erica Carmel, Haifa, Israel) and self-applied daily treatments (808nm, 15minutes, 16.5J/cm2) at home in addition to standard care. The Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0[best]-100[worst]) was collected at baseline and at 1-month post-surgery (FU1M). The %patients achieving the QuickDASH minimal clinical important difference (MCID=9 [Polsonet 2010]) was calculated.

Results:Baseline QuickDASH scores were not significantly different between groups (p=0.2). However, at FU1M, PBM-group had significantly lower disability score compared to baseline while the sham-group did not (QuickDASH baseline vs FU1M: PBM 76±17-vs-68±17 and Sham 68±20-vs-70±22, p=0.044 and p=0.7 respectively by paired ttest). MCID was achieved by 55% (11/20) of PBM-group but only by 24% (4/17) of sham-group (p=0.046 by superiority Fisher’s exact test). No adverse events were reported.

Discussion: Addition of self-applied PBM to standard care was found to significantly reduce disability compared to sham in the first month post-RCAS. Further long-term follow ups of 3, 6, and 12 months are warranted. These findings may indicate the usefulness of PBM for rehabilitation in other orthopedic surgeries.