This study aims to evaluate the efficacy of thread embedding acupuncture using a longitudinal oblique technique from BL40 toward BL57 in patients with knee osteoarthritis. The effects of the intervention will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and knee range of motion (ROM), compared with sham thread embedding acupuncture in a double-blind randomized controlled trial.
Male and female patients aged 51 to 70 years.
Clinically and radiologically diagnosed with bilateral knee osteoarthritis according to ACR (American College of Rheumatology) criteria.
Kellgren-Lawrence grade II or III knee osteoarthritis.
NRS (Numeric Rating Scale) score >3 during activity (activities of daily living or light exercise).
History of knee surgery such as total knee replacement, arthroscopy, or ligament reconstruction.
Inflammatory joint disease or autoimmune conditions (e.g., rheumatoid arthritis, gouty arthritis, spondyloarthritis, or lupus arthritis) assessed via clinical symptoms and/or radiological findings.
Presence of a tumor, wound, or local infection at the injection site.
History of peripheral vascular disease, DVT/thromboembolism, aneurysm or pseudoaneurysm, or coagulation/bleeding disorders.
Factorial
Thread Embedding Acupuncture
DeviceParticipants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The assigned procedures will be administered once, and outcomes will be evaluated over an 8-week follow-up period.
Sham Thread Embedding Acupuncture
DeviceParticipants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The assigned procedures will be administered once, and outcomes will be evaluated over an 8-week follow-up period.
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a 42-item patient-reported outcome questionnaire consisting of five subscales: Pain (9 items), Symptoms (7 items), Activities of Daily Living (17 items), Sport and Recreation (5 items), and Knee-related Quality of Life (4 items). Each subscale is scored from 0 to 100, with higher scores indicating better knee-related health status. Change in KOOS from baseline, assessing knee pain, symptoms, activities of daily living, sport and recreational activities, and knee-related quality of life. KOOS will be assessed at baseline and at weeks 2, 4, and 8 after intervention. Changes in KOOS scores from baseline will be evaluated at each follow-up time point (week 2, week 4, and week 8).
Change in ROM (Range of Motion)
Knee ROM will be assessed using a goniometer by measuring maximum knee flexion and extension in degrees. Measurements will be performed three times by the assessor, and the mean value will be recorded. Change in maximum knee flexion and extension ROM measured using a goniometer in degrees. Measurements are performed three times by the assessor, and the mean value is recorded.
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