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.
Original language | American English |
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Journal | Lasers in Surgery and Medicine |
DOIs | |
State | Accepted/In press - 2023 |
Bibliographical note
Funding Information:We would like to thank Mr. Maroun Yacoub, Mrs. Aya Abu Farha, Mrs. Suzan Abd Algane, Miss Rawan Abu Saleh, Mrs Deema Dai, and Miss Noa Makhervax for administrative and technical assistance. These studies were supported in part by The Stuart Roden Family Research Fund, London, UK; The Saul and Joyce Brandman Fund for Cardiovascular Research, The Alexander Grass Family Research Fund, The Dr. Bruce and Baila Waldholtz Research Fund, and The Dr. Martin and Grace Rosman Research Fund, Faculty of Medicine, The Hebrew University of Jerusalem, Israel.
Publisher Copyright:
© 2023 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.
Keywords
- arthroscopy
- low-level-laser
- photobiomodulation
- rotator cuff