Effects of Invasive Laser Acupuncture on Knee Osteoarthritis: Protocol for a Pilot Clinical Trial

Background: Invasive laser acupuncture (ILA) involves simultaneous application of focused laser irradiation and acupuncture. This study aims to explore the effects of ILA on knee osteoarthritis (KOA) through a pilot clinical trial. Methods: This prospective, patient-blinded, single-center, and para...

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Main Authors: Jae-Hong Kim, Changsop Yang, Jeong-Cheol Shin, Raeon Jang, Gwang-Cheon Park, Kyung-Min Shin, Byoung-Kab Kang, Ae-Ran Kim
Format: Article
Language:English
Published: MEDrang Inc. 2024-11-01
Series:Journal of Acupuncture Research
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author Jae-Hong Kim
Changsop Yang
Jeong-Cheol Shin
Raeon Jang
Gwang-Cheon Park
Kyung-Min Shin
Byoung-Kab Kang
Ae-Ran Kim
author_facet Jae-Hong Kim
Changsop Yang
Jeong-Cheol Shin
Raeon Jang
Gwang-Cheon Park
Kyung-Min Shin
Byoung-Kab Kang
Ae-Ran Kim
author_sort Jae-Hong Kim
collection DOAJ
description Background: Invasive laser acupuncture (ILA) involves simultaneous application of focused laser irradiation and acupuncture. This study aims to explore the effects of ILA on knee osteoarthritis (KOA) through a pilot clinical trial. Methods: This prospective, patient-blinded, single-center, and parallel-arm pilot randomized controlled trial will enroll 45 patients with KOA randomized to the control, 830, and 650 groups. All patients will receive education on exercise and self-care. Their ILA treatment will correspond to their group (control group, sham; 830 group, 830 nm; 650 group, 650-nm wavelength laser) for 10 minutes once daily, twice weekly for 6 weeks at EX-LE4, ST35, ST34, SP10, SP9, GB34, and EXLE2 acupoints. Results: The primary endpoint will be changes in the visual analog scale (VAS) score of pain at rest and during activity 1 week after interventions (week 7). The secondary outcomes will be the responder rate; VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total, WOMAC pain subscale, WOMAC function subscale, European quality of life five-dimension five-level scale, and patient global assessment scores; and rescue medication doses. Safety outcome measures will include blood chemistry parameters, occurrence of adverse events, pulse rate, and blood pressure. The efficacy outcomes will be measured at baseline, visit after six treatments, 1 week after the last treatment, and 6 weeks after the last treatment. Conclusion: The findings will provide preliminary data on the effects of ILA on KOA.
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spelling doaj-art-6b74cd9b84bc488ea8caaac87cee6e132024-12-02T03:16:47ZengMEDrang Inc.Journal of Acupuncture Research2586-288X2586-28982024-11-0141300309https://doi.org/10.13045/jar.24.0035Effects of Invasive Laser Acupuncture on Knee Osteoarthritis: Protocol for a Pilot Clinical TrialJae-Hong Kim0https://orcid.org/0000-0002-4806-3401Changsop Yang1https://orcid.org/0000-0003-1277-3329Jeong-Cheol Shin2https://orcid.org/0000-0002-3162-4620Raeon Jang3https://orcid.org/0009-0008-3150-1197Gwang-Cheon Park4https://orcid.org/0000-0003-0986-2048Kyung-Min Shin5https://orcid.org/0000-0001-7850-8574Byoung-Kab Kang6https://orcid.org/0000-0002-3016-2428Ae-Ran Kim7https://orcid.org/0000-0003-3600-0806Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Dongshin University, Naju, KoreaKM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, KoreaDepartment of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Dongshin University, Naju, KoreaDepartment of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Dongshin University, Naju, KoreaClinical Research Center, Dongshin University Gwangju Korean Medicine Hospital, Gwangju, KoreaKM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, KoreaKM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, KoreaClinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, KoreaBackground: Invasive laser acupuncture (ILA) involves simultaneous application of focused laser irradiation and acupuncture. This study aims to explore the effects of ILA on knee osteoarthritis (KOA) through a pilot clinical trial. Methods: This prospective, patient-blinded, single-center, and parallel-arm pilot randomized controlled trial will enroll 45 patients with KOA randomized to the control, 830, and 650 groups. All patients will receive education on exercise and self-care. Their ILA treatment will correspond to their group (control group, sham; 830 group, 830 nm; 650 group, 650-nm wavelength laser) for 10 minutes once daily, twice weekly for 6 weeks at EX-LE4, ST35, ST34, SP10, SP9, GB34, and EXLE2 acupoints. Results: The primary endpoint will be changes in the visual analog scale (VAS) score of pain at rest and during activity 1 week after interventions (week 7). The secondary outcomes will be the responder rate; VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total, WOMAC pain subscale, WOMAC function subscale, European quality of life five-dimension five-level scale, and patient global assessment scores; and rescue medication doses. Safety outcome measures will include blood chemistry parameters, occurrence of adverse events, pulse rate, and blood pressure. The efficacy outcomes will be measured at baseline, visit after six treatments, 1 week after the last treatment, and 6 weeks after the last treatment. Conclusion: The findings will provide preliminary data on the effects of ILA on KOA.knee osteoarthritislaser acupuncturelow-level laserrandomized controlled trialstudy protocol
spellingShingle Jae-Hong Kim
Changsop Yang
Jeong-Cheol Shin
Raeon Jang
Gwang-Cheon Park
Kyung-Min Shin
Byoung-Kab Kang
Ae-Ran Kim
Effects of Invasive Laser Acupuncture on Knee Osteoarthritis: Protocol for a Pilot Clinical Trial
Journal of Acupuncture Research
knee osteoarthritis
laser acupuncture
low-level laser
randomized controlled trial
study protocol
title Effects of Invasive Laser Acupuncture on Knee Osteoarthritis: Protocol for a Pilot Clinical Trial
title_full Effects of Invasive Laser Acupuncture on Knee Osteoarthritis: Protocol for a Pilot Clinical Trial
title_fullStr Effects of Invasive Laser Acupuncture on Knee Osteoarthritis: Protocol for a Pilot Clinical Trial
title_full_unstemmed Effects of Invasive Laser Acupuncture on Knee Osteoarthritis: Protocol for a Pilot Clinical Trial
title_short Effects of Invasive Laser Acupuncture on Knee Osteoarthritis: Protocol for a Pilot Clinical Trial
title_sort effects of invasive laser acupuncture on knee osteoarthritis protocol for a pilot clinical trial
topic knee osteoarthritis
laser acupuncture
low-level laser
randomized controlled trial
study protocol
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