A Pilot Randomized Trial Of Invasive Laser Acupuncture Combined With Electroacupuncture For Knee Osteoarthritis

Knee osteoarthritis (KOA) is a common degenerative joint disease impairing mobility and quality of life, especially in the elderly. Conventional treatments often fail to address its multifactorial nature. This study explores invasive laser acupuncture integrated with electroacupuncture, delivering precise and minimally invasive multimodal stimulation. A randomized, sham-controlled, assessor-blinded, pilot sized clinical trial will evaluate the safety and efficacy of laser acupuncture combined with electroacupuncture in 45 KOA patients. Participants will be assigned to one of three groups: (1) 650 nm laser with electroacupuncture, (2) 830 nm laser with electroacupuncture, or (3) sham laser with sham electroacupuncture. Treatments occur twice weekly for four weeks. Primary outcome: pain reduction (VAS). Secondary outcomes: functional improvement (KOOS), quality of life (EQ-5D-5L), and safety. Of 45 randomized patients, 43 completed the trial. At week 5, VAS at rest decreased from 62.5 ± 11.3 to 32.7 ± 15.6 in the 650-nm group, 59.7 ± 8.6 to 30.5 ± 23.0 in the 830-nm group, and 66.9 ± 10.3 to 41.9 ± 20.5 in the control group. VAS during activity decreased from 68.7 ± 8.7 to 32.8 ± 14.6, 67.8 ± 7.6 to 31.4 ± 22.0, and 69.3 ± 10.2 to 43.8 ± 20.6, respectively. KOOS improved to 84.7 ± 19.5 (650 nm) and 83.3 ± 25.5 (830 nm) but not in controls (91.1 ± 21.1). EQ-5D scores improved slightly but without significance. PGA rose to 6.7 ± 1.1 (650 nm), 7.1 ± 1.5 (830 nm), and 6.8 ± 1.0 (control). No serious adverse events occurred; mild bruising was the most common event. This pilot-sized trial proposes an innovative, patient-centered approach to KOA management, potentially reducing reliance on medications and invasive procedures. And is a cornerstone to larger clinical trials. Trial Registration: CRIS PRE20231022-003.