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/cm 2 ) 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 χ 2 . 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.