Photobiomodulation self-treatment at home after rotator cuff arthroscopic repair accelerates improvement in pain, functionality, and quality of life: A double-blind, sham-controlled, randomized clinical trial

Abstract

Objective: To determine whether self-applied photobiomodulation (PBM) therapy at home, following rotator cuff arthroscopic surgery (RCAS) can accelerate improvement in patient-reported outcomes within the first 6 months postsurgery. Methods: This study was a prospective, double-blind, sham-controlled, randomized clinical trial (NCT04593342). Patients (n = 50, age 55 ± 7 years, male:female 29:21) who underwent primary RCAS were randomized to receive active (n = 22) or sham (n = 28) PBM devices (B-Cure Laser Pro, Erica B-Cure LASER Ltd., Haifa, Israel) in addition to standard care. Patients self-applied the treatments (808 nm, 15 min, 16.5 J/cm2) at home for 3 months postsurgery. Evaluations were conducted before the surgery (baseline) and at 1–3 and 6 months post-RCAS (FU-1M, FU-3M, FU-6M), and included Constant–Murley score (CMS), range of motion (ROM), subjective pain by visual analogue scale (VAS), disability by QuickDASH, and quality of life (QOL) by SF-12. The difference from baseline to follow-up (ΔFU), %patients achieving minimal clinical important difference (MCID), and patient acceptable symptom score (PASS) were calculated. Comparisons were conducted with superiority 2-sample t test and χ2. Results: Baseline values were not significantly different between groups. Both groups had similar improvements in CMS and ROM. However, compared to Sham, PBM significantly accelerated subjective pain reduction at 3 and 6 months (VAS mean ± SD, PBM-vs-Sham: ΔFU-3M 32 ± 33 vs. 16 ± 27, p = 0.040; ΔFU-6M: 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 accelerated improvement in functionality and QOL at 6 months (QuickDASH ΔFU-6M: 30 ± 24 vs. 18 ± 14, p = 0.029; SF-12 physical component 6.8 ± 12.5 vs. 0.4 ± 8.6, p = 0.031; SF-12 mental component 8.5 ± 9.1 vs. 2.2 ± 12, p = 0.032). Conclusions: Self-applied photobiomodulation following RCAS significantly accelerates decrease in pain and disability, and improves QOL. This nonpharmacologic add-on therapeutic modality is easy to use and encourages active patient involvement. Its potential use in rehabilitation following other surgeries should be considered. Level of evidence: Level I, high-quality RCT.