PMID- 37288499 OWN - NLM STAT- MEDLINE DCOM- 20230814 LR - 20230817 IS - 1096-9101 (Electronic) IS - 0196-8092 (Linking) VI - 55 IP - 7 DP - 2023 Sep TI - 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. PG - 662-673 LID - 10.1002/lsm.23692 [doi] AB - 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 (DeltaFU), %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 chi(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: DeltaFU-3M 32 +/- 33 vs. 16 +/- 27, p = 0.040; DeltaFU-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 DeltaFU-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. CI - (c) 2023 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC. FAU - Abufoul, Rabie AU - Abufoul R AD - Orthopedic Department, The Holy Family Hospital, Nazareth, Israel. FAU - Gavish, Lilach AU - Gavish L AUID- ORCID: 0000-0003-0392-8958 AD - Institute for Research in Military Medicine (IRMM), Faculty of Medicine, The Hebrew University of Jerusalem and the Israel Defense Forces Medical Corps, Jerusalem, Israel. AD - The Saul and Joyce Brandman Hub for Cardiovascular Research and the Department of Medical Neurobiology, Institute for Medical Research (IMRIC), Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel. FAU - Haddad, Marwan AU - Haddad M AD - Orthopedic Department, The Holy Family Hospital, Nazareth, Israel. LA - eng SI - ClinicalTrials.gov/NCT04593342 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20230608 PL - United States TA - Lasers Surg Med JT - Lasers in surgery and medicine JID - 8007168 SB - IM MH - Humans MH - Male MH - Female MH - Middle Aged MH - *Rotator Cuff/surgery MH - *Rotator Cuff Injuries/surgery MH - Quality of Life MH - Prospective Studies MH - Treatment Outcome MH - Pain MH - Range of Motion, Articular OTO - NOTNLM OT - arthroscopy OT - low-level-laser OT - photobiomodulation OT - rotator cuff EDAT- 2023/06/08 06:42 MHDA- 2023/08/14 06:42 CRDT- 2023/06/08 04:38 PHST- 2023/05/22 00:00 [revised] PHST- 2022/12/21 00:00 [received] PHST- 2023/05/23 00:00 [accepted] PHST- 2023/08/14 06:42 [medline] PHST- 2023/06/08 06:42 [pubmed] PHST- 2023/06/08 04:38 [entrez] AID - 10.1002/lsm.23692 [doi] PST - ppublish SO - Lasers Surg Med. 2023 Sep;55(7):662-673. doi: 10.1002/lsm.23692. Epub 2023 Jun 8.