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

Rabie Abufoul; Lilach Gavish; Marwan Haddad

doi:10.1002/lsm.23692

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

Rabie Abufoul, Lilach Gavish^*, Marwan Haddad

^*Corresponding author for this work

Institute for Research in Military Medicine

Research output: Contribution to journal › Article › peer-review

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
Journal	Lasers in Surgery and Medicine
DOIs	https://doi.org/10.1002/lsm.23692
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

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@article{2ed7b6bae4ce42d0b49f0895a8dfdb9f,

title = "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.",

keywords = "arthroscopy, low-level-laser, photobiomodulation, rotator cuff",

author = "Rabie Abufoul and Lilach Gavish and Marwan Haddad",

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: {\textcopyright} 2023 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.",

year = "2023",

doi = "10.1002/lsm.23692",

language = "American English",

journal = "Lasers in Surgery and Medicine",

issn = "0196-8092",

publisher = "Wiley-Liss Inc.",

}

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. / Abufoul, Rabie; Gavish, Lilach; Haddad, Marwan.
In: Lasers in Surgery and Medicine, 2023.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Abufoul, Rabie

AU - Gavish, Lilach

AU - Haddad, Marwan

N1 - 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.

PY - 2023

Y1 - 2023

N2 - 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.

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/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.

KW - arthroscopy

KW - low-level-laser

KW - photobiomodulation

KW - rotator cuff

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U2 - 10.1002/lsm.23692

DO - 10.1002/lsm.23692

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AN - SCOPUS:85161588401

SN - 0196-8092

JO - Lasers in Surgery and Medicine

JF - Lasers in Surgery and Medicine

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