Invasive Laser Acupuncture vs Electroacupuncture for Non-specific Chronic Low Back Pain : Protocol for a Randomized Clinical Trial

Yejin Hong¹Dongwoo Nam^1,2Changsop Yang³Byoung-Kab Kang³Ae-Ran Kim⁴Kyung Min Shin³Jihye Kim⁵Saerom Jeon⁶Gwang-Cheon Park⁷Jeong Cheol Shin^7,8Jae-Hong Kim^7,8*

• ¹Department of Acupuncture and Moxibustion, Kyung Hee University Medical Center, Seoul, Republic of Korea
• ²Department of Acupuncture and Moxibustion, Kyung Hee University College of Korean Medicine, Dongdaemun-gu, Republic of Korea
• ³KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
• ⁴Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
• ⁵Digital Health Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
• ⁶Korean Medicine Research, Seoul, Republic of Korea
• ⁷Clinical Research Center, Dongshin University Gwangju Korean Medicine Hospital, Seoul, Republic of Korea
• ⁸Department of Acupuncture and Moxibustion Medicine, Dongshin University College of Korean Medicine, Naju-si, Republic of Korea

Background: This study aims to evaluate the short-term efficacy of 650 nm invasive laser acupuncture (ILA) compared to conventional electroacupuncture (EA) in reducing pain in patients with non-specific chronic low back pain (NSCLBP). Method: This is a prospective, multicenter, randomized, single-blind, controlled trial. Ninety patients with NSCLBP will be recruited and randomly assigned (1:1) to receive either 650 nm ILA or EA. Treatments will be administered at the bilateral acupoints BL23, BL24, BL25, and GB30 for 10 min per session, twice weekly for 4 weeks (8 sessions in total). The primary outcome is the change in the Visual Analog Scale (VAS) score 1 week after treatment completion. Secondary outcomes include VAS scores at interim and follow-up time points, Oswestry Disability Index, European Quality of Life Five Dimension Five-Level Scale, and the proportion of responders. Safety assessments and adverse event monitoring will be conducted throughout the trial. Conclusions: This multicenter randomized controlled trial compares the effects of ILA and EA with the change in VAS as a primary efficacy endpoint in 90 patients with NSCLBP. This findings will provide clinical evidence of the comparative efficacy and safety of 650 nm ILA versus EA in patients with NSCLBP, supporting its potential as a viable non-pharmacological treatment option. Trial registration: Clinical Research Information Service (https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=M& pageSize=10&page=undefined&seq=29960&status=5&seq_group=29960, identifier KCT0010475).