2015 ISAKOS Biennial Congress Paper #0

Photobiomodulation Home-Use Device Reduces Pain and Improves Quality of Life Post Arthroscopic Rotator Cuff Repair - A Double-Blind, Sham-Controlled, Randomized Clinical Trial

Lilach Gavish, PhD, MPH, Jerusalem ISRAEL
Rabie Bassam Abu Foul, MD, Nazareth ISRAEL
Marwan Hadad, MD, Nazareth ISRAEL
Holy Family Hospital, Nazareth, ISRAEL

FDA Status Not Applicable

Summary: Self-applied photobiomodulation significantly accelerates reduction in pain and improvement in quality of life following rotator cuff arthroscopic repair.

Abstract:

Objective

The rehabilitation period following rotator cuff arthroscopic surgery (RCAS) is characterized with significant pain and reduced quality of life (QOL). The current study was designed to evaluate the efficacy of self-applied photobiomodulation (PBM), a non-ionizing, non-thermal red to near-infrared optical irradiation, during the first 6 months post-RCAS.

Methods

This was a prospective, double-blind, sham-controlled, randomized, clinical trial (NCT04593342). Patients (n=50, Age 55±7yo, Male:Female 29:21) that underwent primary RCAS were randomized to receive active (n=22) or sham (n=28) B-Cure Laser PBM devices (Erica Carmel, Haifa, Israel) and to self-apply the treatments (808nm, 15minutes, 16.5J/cm2) at home additionaly to standard care. Outcomes including shoulder function by the Constant-Murley Score (CMS); Subjective pain by visual analogue scale (VAS score=0[none]-100[intolerable], and QOL by SF-12, were collected before the surgery (Baseline) and at follow-ups 1-3-and-6 months’ post-RCAS (FU1, FU-3M, FU-6M). The %patients achieving minimal clinical important difference ([MCID]=15) and patient acceptable symptom state ([PASS]=17) was calculated. Groups were compared by superiority 2-sample t-test and chi-square.

Results

Baseline scores were not significantly different between groups. As expected, post-RCAS, the CMS improved over time and was similar for both groups. However, compared to sham, PBM significantly accelerated the reduction in subjective pain at 3 and 6 months (Change over baseline in VAS score, mean±SD, PBM vs Sham: FU3 32±33-vs-16±27, p=0.040; FU6 41±36-vs-23±26, p=0.038), with a significantly higher proportion of patients achieving MCID at 3 months (76%-vs-48%, p=0.027) and PASS at 6 months (48%-vs-23%, p=0.044). PBM also significantly improved the reported QOL at 6 months (physical component 6.8±12.5-vs-0.4±8.6, p=0.031; Mental component 8.5±9.1-vs-2.2±12, p=0.032).

Discussion

Self-applied photobiomodulation was found to significantly accelerate reduction in pain and improvement in quality of life following rotator cuff arthroscopic surgery. These findings may indicate the usefulness of photobiomodulation for rehabilitation in other orthopedic surgeries.

Sponsored by Erica Carmel ltd.