Assessing the effectiveness of the SOLIO Alfa Cure Plus device in treating low back pain: a randomized controlled study

Abstract Background Nonspecific low back pain (LBP) has become a significant worldwide public health problem. It is estimated that 84% of people present it at some point in their lives, in which 23% experience its chronic form, negatively affecting their daily lives. Because pain management tool tha...

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Main Authors: Hadari Yotam, Pesah Galia, Goor-Aryeh Itay, Ungar Lior
Format: Article
Language:English
Published: BMC 2025-01-01
Series:Journal of Orthopaedic Surgery and Research
Subjects:
Online Access:https://doi.org/10.1186/s13018-024-05441-0
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author Hadari Yotam
Pesah Galia
Goor-Aryeh Itay
Ungar Lior
author_facet Hadari Yotam
Pesah Galia
Goor-Aryeh Itay
Ungar Lior
author_sort Hadari Yotam
collection DOAJ
description Abstract Background Nonspecific low back pain (LBP) has become a significant worldwide public health problem. It is estimated that 84% of people present it at some point in their lives, in which 23% experience its chronic form, negatively affecting their daily lives. Because pain management tool that doesn’t require a firm diagnosis, the development of a device, as SOLIO Alfa Cure Plus, that emanates low level laser therapy, radio frequency and heat with the goal of easing chronic back pain was highly expected. Methods randomized, single blinded, controlled trial. Measures: Numeric Pain Rating Scale (NPRS), the Oswestry Disability Index (ODI) and the Schober’s test. Thirty-seven patients completed pain, disability, and lower back flexibility scales. Randomization was obtained by having an equal amount of sham and real devices and distributing them randomly to patients out of a box where the devices were. Results We observed a larger pain relief in the SOLIO group (42% vs. 23% p = 0.03), and a higher improvement in flexibility (13%) compared to a worsening in the sham group (6.5%; p = 0.04). Conclusion We concluded that utilizing the SOLIO Alfa Cure Plus device may dramatically reduce back pain and allow patients to experience an improvement in quality of life as a result. Trial registration: The clinical trials registration is 8475-21-SMC.
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institution Kabale University
issn 1749-799X
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publishDate 2025-01-01
publisher BMC
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series Journal of Orthopaedic Surgery and Research
spelling doaj-art-f785a9948ff241b193ec887a748ae06c2025-01-26T12:43:35ZengBMCJournal of Orthopaedic Surgery and Research1749-799X2025-01-012011610.1186/s13018-024-05441-0Assessing the effectiveness of the SOLIO Alfa Cure Plus device in treating low back pain: a randomized controlled studyHadari Yotam0Pesah Galia1Goor-Aryeh Itay2Ungar Lior3Institute for Pain Medicine, Chaim Sheba Medical CenterInstitute for Pain Medicine, Chaim Sheba Medical CenterInstitute for Pain Medicine, Chaim Sheba Medical CenterInstitute for Pain Medicine, Chaim Sheba Medical CenterAbstract Background Nonspecific low back pain (LBP) has become a significant worldwide public health problem. It is estimated that 84% of people present it at some point in their lives, in which 23% experience its chronic form, negatively affecting their daily lives. Because pain management tool that doesn’t require a firm diagnosis, the development of a device, as SOLIO Alfa Cure Plus, that emanates low level laser therapy, radio frequency and heat with the goal of easing chronic back pain was highly expected. Methods randomized, single blinded, controlled trial. Measures: Numeric Pain Rating Scale (NPRS), the Oswestry Disability Index (ODI) and the Schober’s test. Thirty-seven patients completed pain, disability, and lower back flexibility scales. Randomization was obtained by having an equal amount of sham and real devices and distributing them randomly to patients out of a box where the devices were. Results We observed a larger pain relief in the SOLIO group (42% vs. 23% p = 0.03), and a higher improvement in flexibility (13%) compared to a worsening in the sham group (6.5%; p = 0.04). Conclusion We concluded that utilizing the SOLIO Alfa Cure Plus device may dramatically reduce back pain and allow patients to experience an improvement in quality of life as a result. Trial registration: The clinical trials registration is 8475-21-SMC.https://doi.org/10.1186/s13018-024-05441-0Nonspecific low back painSOLIO Alfa Cure Plus deviceDiagnosisPain visual analog scaleRadiofrequencyLLLT devices
spellingShingle Hadari Yotam
Pesah Galia
Goor-Aryeh Itay
Ungar Lior
Assessing the effectiveness of the SOLIO Alfa Cure Plus device in treating low back pain: a randomized controlled study
Journal of Orthopaedic Surgery and Research
Nonspecific low back pain
SOLIO Alfa Cure Plus device
Diagnosis
Pain visual analog scale
Radiofrequency
LLLT devices
title Assessing the effectiveness of the SOLIO Alfa Cure Plus device in treating low back pain: a randomized controlled study
title_full Assessing the effectiveness of the SOLIO Alfa Cure Plus device in treating low back pain: a randomized controlled study
title_fullStr Assessing the effectiveness of the SOLIO Alfa Cure Plus device in treating low back pain: a randomized controlled study
title_full_unstemmed Assessing the effectiveness of the SOLIO Alfa Cure Plus device in treating low back pain: a randomized controlled study
title_short Assessing the effectiveness of the SOLIO Alfa Cure Plus device in treating low back pain: a randomized controlled study
title_sort assessing the effectiveness of the solio alfa cure plus device in treating low back pain a randomized controlled study
topic Nonspecific low back pain
SOLIO Alfa Cure Plus device
Diagnosis
Pain visual analog scale
Radiofrequency
LLLT devices
url https://doi.org/10.1186/s13018-024-05441-0
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AT pesahgalia assessingtheeffectivenessofthesolioalfacureplusdeviceintreatinglowbackpainarandomizedcontrolledstudy
AT gooraryehitay assessingtheeffectivenessofthesolioalfacureplusdeviceintreatinglowbackpainarandomizedcontrolledstudy
AT ungarlior assessingtheeffectivenessofthesolioalfacureplusdeviceintreatinglowbackpainarandomizedcontrolledstudy