Importance <p>Knee osteoarthritis (OA) is a common degenerative joint disease in aging populations. Knee OA is difficult to cure and requires ongoing management. Thread embedding acupuncture (TEA) is a popular Korean medical treatment for knee OA. However, clinical evidence of its effectiveness and safety is insufficient.</p> Objective <p>This study aims to evaluate the effectiveness and safety of TEA compared with acupuncture for knee OA.</p> Design, Setting, and Population <p>A two-group, two-arm, parallel, single-center, randomized, controlled, and assessor-blinded pilot trial will be conducted. A total of sixty patients aged between 40 and 85 years old will be recruited.</p> Exposures <p>The TEA group will receive four sessions of TEA treatment over 4 weeks. The acupuncture group will receive eight sessions of acupuncture treatment over 4 weeks. A follow-up assessment will be conducted in week 8 for both groups.</p> Main Outcomes and Measures <p>Assessments will be performed at baseline, 2 weeks, 4 weeks, and 8 weeks. The primary outcome will be the mean change in the visual analog scale between the two groups at 4 weeks. The secondary outcomes will be the mean change in the Korean Western Ontario and McMaster Universities Osteoarthritis Index, knee range of motion, EuroQol 5-Dimension, patient global impression of change, and dosage of rescue medication. Statistical analysis will be conducted and the level of significance will be achieved in each variables.</p> Results <p>The results will be published in a peer-reviewed journal.</p> Conclusions and Relevance <p>This study provides a rationale for the effectiveness and safety of TEA for knee OA by comparing TEA treatment with acupuncture.</p>